Leigh Syndrome, LHON, MELAS, Mitochondrial Disease, Mitochondrial DNA tRNALeu(UUR) m.3243A<G Mutation
Conditions
Brief summary
Mitochondrial Diseases are rare progressive, multi-system, often early fatal disorders affecting both children and adults. KH176 is a novel chemical entity currently under development for the treatment of inherited mitochondrial diseases, including MELAS (Mitochondrial Encephalomyopathy, Lactic acidosis, and Stroke-like episodes), Leigh's Disease and Leber's Hereditary Optic Neuropathy (LHON). KH176 is a potent intracellular redox modulating agent targeting the reactive oxygen species which are important in the pathogenesis of disorders of mitochondrial oxidative phosphorylation. After demonstrating a favourable safety profile in the pre-clinical testing, the safety, tolerability and pharmacokinetic and pharmacodynamic characteristics of the compound will now be evaluated in healthy male subjects in this trial
Interventions
DRUGKH176
DRUGplacebo
Sponsors
University Ghent
Khondrion BV
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy as assessed by medical history, physical examination, Vital Signs, Clinical Laboratory, ECG
Exclusion criteria
* Allergies, * Concomitant medication, * concomitant disease, * relevant surgery, * recent blood donation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SAD: Change From Baseline in ECG Results by Timepoint: Corrected QT Interval According to Fridericia's Formula (QTcF) | Baseline, 1, 2, 4, 6, 8, 12, 24 hours, 7 day follow up | The baseline ECG recording consists of a triplicate recording (3 recordings of a least 3 complexes within a 5 minute window) prior to dosing on Day 1. For the evaluation of the corrected QT intervals the average of the 3 recordings will be taken as baseline. Other ECG recordings will be singlet (one recording of at least 3 complexes) prior to dosing. QTcF is calculated as the quotient between the QT interval in milliseconds and the cube root of the RR interval in seconds, according to Fridericia's formula. |
| Pharmacodynamics of KH176 | Day 1, day 7 | Change from baseline in biochemistry related to Oxidative Phosphorylation (OXPHOS) (glutathione, lactate); MAD group |
| Relationship to Study Drug and Severity of Treatment-emergent Adverse Events | 4 months | — |
| Change From Baseline in Hematology Laboratory Test Results by Timepoint: Red Blood Cell Count. SAD Group | Baseline (pre-dose Day 1), 24h post dose, FU (7 days after last dosing) | Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. |
| Change From Baseline in Hematology Laboratory Test Results by Timepoint: Erythrocyte Sedimentation Rate (SAD Group) | Baseline (pre-dose Day1), 24h post dose, FU (7 days after last dosing) | — |
| Change From Baseline in Hematology Laboratory Test Results by Timepoint: Erythrocyte Sedimentation Rate MAD Group | Baseline (pre-dose Day 1), Day 3, Day 8, FU (7 days after last dosing) | — |
| Change From Baseline in Hematology Laboratory Test Results by Timepoint: Hematocrit SAD Group | Baseline (pre-dose Day 1), 24 h postdose, FU (7 days after last dosing) | Hematocrit is a measure of the ratio of red blood cells (RBCs) in the blood by volume. Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. |
| Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Haemoglobin. SAD | Baseline (pre-dose Day 1), 24 h post dose, FU (7 days after last dosing) | Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. |
| Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Hemoglobin Concentration - SAD | Baseline (pre-dose Day 1), 24 h post dose, FU (7 days after last dosing) | Erythrocyte mean corpuscular hemoglobin concentration (MCHC) is a measure of the average concentration of hemoglobin per red blood cell. Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. |
| Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Volume - SAD | Baseline (pre-dose Day 1), 24 h post dose, FU (7 days after last dosing) | Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. |
| MAD: Change From Baseline in ECG Results by Time Point: QTcF | Baseline, Day1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7 | The baseline ECG recording consists of a triplicate recording (3 recordings of a least 3 complexes within a 5 minute window) prior to dosing on Day 1. For the evaluation of the corrected QT intervals the average of the 3 recordings will be taken as baseline. Other ECG recordings will be singlet (one recording of at least 3 complexes) prior to dosing, or around the expected Cmax on Day 1 or 7 for the multiple-dose part. QTcF is calculated as the quotient between the QT interval in milliseconds and the cube root of the RR interval in seconds, according to Fridericia's formula. |
| Change From Baseline in Hematology Laboratory Test Results by Timepoint: White Blood Cell Count. SAD Group | Baseline (pre-dose Day 1), 24h post dose, FU (7 days after last dosing) | Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. |
| Change From Baseline in Hematology Laboratory Test Results by Timepoint: Lymphocytes. SAD Group | Baseline (pre-dose Day 1), 24h post dose, FU (7 days post dose) | Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. |
| Change From Baseline in Hematology Laboratory Test Results by Timepoint: Neutrophils. SAD Group | Baseline (pre-dose Day 1), 24h post dose, FU (7 days after last dosing) | Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. |
| Change From Baseline in Hematology Laboratory Test Results by Timepoint: Hematocrit MAD Group | Baseline (pre-dose Day 1), Day 3, Day 8, FU (7 days post dose) | Hematocrit is a measure of the ratio of red blood cells (RBCs) in the blood by volume. Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value |
| Change From Baseline in Hematology Laboratory Test Results by Timepoint: Eosinophils. SAD Group | Baseline (pre-dose Day 1), 24h post dose, FU (7 days after last dosing) | Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. |
| Change From Baseline in Hematology Laboratory Test Results by Timepoint: Thrombocytes. SAD Group | Baseline (pre-dose Day 1), 24h, FU (7 days post-dose) | Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. |
| Change From Baseline in Hematology Laboratory Test Results by Timepoint: Basophils. SAD Group | Baseline (pre-dose Day 1), 24h post dose, FU (7 days post-dose) | Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value ateach timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. |
| Change From Baseline in Hematology Laboratory Test Results by Timepoint: Monocytes. SAD Group | Baseline (pre-dose Day 1), 24h post dose, FU (7 days post-dose) | Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. |
| Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Volume. MAD Group | Baseline (pre-dose Day 1), Day 3, Day 8, FU (7 days post dose) | Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. |
| Change From Baseline in Hematology Laboratory Test Results by Timepoint: Hemoglobin. MAD Group | Baseline (pre-dose Day 1), Day 3, Day 8, FU (7 days post dose) | Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. |
| Change From Baseline in Hematology Laboratory Test Results by Timepoint: White Blood Cell Count. MAD | Baseline (pre-dose Day 1), Day 3, Day 8, FU (7 days post dose) | Blood samples were collected from participants at the indicated time points for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each time point are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. |
| Change From Baseline in Hematology Laboratory Test Results by Timepoint: Neutrophils. MAD Group | Baseline (pre-dose Day 1), Day 3, Day 8, FU (7 days post dose) | Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. |
| Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Haemoglobin Concentration. MAD Group | Baseline (pre-dose Day 1), Day 3, Day 8, FU (7 days post dose) | Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. |
| Change From Baseline in Hematology Laboratory Test Results by Timepoint: Lymphocytes. MAD Group | Baseline (pre-dose Day 1), Day 3, Day 8, FU (7 days post dose) | Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. |
| Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Hemoglobin. MAD Group | Baseline (pre-dose Day 1), Day 3, Day 8, FU (7 days post dose) | Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. |
| Change From Baseline in Hematology Laboratory Test Results by Timepoint: Red Blood Cell Count. MAD Group | Baseline (pre-dose Day 1), Day 3, Day 8, FU (7 days post dose) | Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. |
| Change From Baseline in Hematology Laboratory Test Results by Timepoint: Eosinophils. MAD Group | Baseline (pre-dose Day 1), Day 3, Day 8, FU (7 days post dose) | Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. |
| Change From Baseline in Hematology Laboratory Test Results by Timepoint: Monocytes. MAD Group | Baseline (pre-dose Day 1), Day 3, Day 8, FU (7 days post dose) | Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. |
| Change From Baseline in Hematology Laboratory Test Results by Timepoint: Thrombocytes. MAD Group | Baseline (pre-dose Day 1), Day 3, Day 8, FU (7 days post dose) | Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. |
| Change From Baseline in Hematology Laboratory Test Results by Timepoint: Basophils. MAD Group | Baseline (pre-dose Day 1), Day 3, Day 8, FU (7 days post dose) | Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. |
| Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Aspartate Aminotransferase. SAD Group | Baseline (pre-dose Day 1), 24h post dose, FU (7 days post dose) | Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. |
| Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Total Protein. SAD Group | Baseline (pre-dose Day 1), 24h post dose, FU (7 days post dose) | Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. |
| Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Gamma-GT. SAD Group | Baseline (pre-dose Day 1), 24h post dose, FU (7 days post dose) | Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value |
| Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Alkaline Phosphatase. SAD Group | Baseline (pre-dose Day 1), 24h post dose, FU (7 days post dose) | Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. |
| Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Creatinine. SAD Group | Baseline (pre-dose Day 1), 24h post dose, FU (7 days post dose) | Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. |
| Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Chloride. SAD Group | Baseline (pre-dose Day 1), 24h post dose, FU (7 days post dose) | Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. |
| Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Total Bilirubin. SAD Group | Baseline (pre-dose Day 1), 24h post dose, FU (7 days post dose) | Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. |
| Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Alanine Aminotransferase. SAD Group | Baseline (pre-dose Day 1), 24h post dose, FU (7 days post dose) | Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. |
| Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Creatinine Kinase. SAD Group | Baseline (pre-dose Day 1), 24h post dose, FU (7 days post dose) | Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. |
| Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Urea. SAD Group | Baseline (pre-dose Day 1), 24h post dose, FU (7 days post dose) | Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. |
| KH173 + KH183: Percentage of Administered Dose Excreted in Urine: MAD | Day 7 Post dose | Urine concentrations of KH176 and KH183 were analysed after multiple-dose administration of doses of 100, 200 and 400 mg b.i.d. |
| Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Sodium. SAD Group | Baseline (pre-dose Day 1), 24h post dose, FU (7 days post dose) | Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. |
| Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Potassium. SAD Group | Baseline (pre-dose Day 1), 24h post dose, FU (7 days post dose) | Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. |
| Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Phosphate. SAD Group | Baseline (pre-dose Day 1), 24h post dose, FU (7 days post dose) | Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. |
| Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Calcium (Corrected for Albumin). SAD Group | Baseline (pre-dose Day 1), 24h post dose, FU (7 days post dose) | Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. |
| Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Uric Acid. SAD Group | Baseline (pre-dose Day 1), 24h post dose, FU (7 days post dose) | Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. |
| Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Triiodothyronine (T3). SAD Group | Baseline (pre-dose Day 1), 24h post dose, FU (7 days post dose) | Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. |
| Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Lipase. SAD Group | Baseline (pre-dose Day 1), 24h post dose, FU (7 days post dose) | Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. |
| Change From Baseline in Chemistry Laboratory Test Results by Timepoint: (Fasting) Glucose. SAD Group | Baseline (pre-dose Day 1), 24h post dose, FU (7 days post dose) | Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. |
| Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Human Serum Albumin. SAD Group | Baseline (pre-dose Day 1), 24h post dose, FU (7 days post dose) | Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. |
| Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Cholesterol. SAD Group | Baseline (pre-dose Day 1), 24h post dose, FU (7 days post dose) | Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. |
| Change From Baseline in Chemistry Laboratory Test Results by Timepoint: High Density Lipoproteins. SAD Group | Baseline (pre-dose Day 1), 24h post dose, FU (7 days post dose) | Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. |
| Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Triglycerides. SAD Group | Baseline (pre-dose Day 1), 24h post dose, FU (7 days post dose) | Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. |
| Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Low Density Lipoproteins. SAD Group | Baseline (pre-dose Day 1), 24h post dose, FU (7 days post dose) | Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. |
| Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Bicarbonate. SAD Group | Baseline (pre-dose Day 1), 24h post dose, FU (7 days post dose) | Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. |
| Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Thyroid-stimulating Hormone. SAD Group | Baseline (pre-dose Day 1), 24h post dose, FU (7 days post dose) | Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. |
| Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Thyroxine (T4). SAD Group | Baseline (pre-dose Day 1), 24h post dose, FU (7 days post dose) | Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. |
| Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Lactate. SAD Group | Baseline (pre-dose Day 1), 24h post dose, FU (7 days post dose) | Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. |
| Change From Baseline in Chemistry Laboratory Test Results by Time Point: Total Protein. MAD Group | Baseline (pre-dose Day1), Day 3, Day 8, FU (one week after last dosing) | Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. |
| Change From Baseline in Chemistry Laboratory Test Results by Time Point: Alkaline Phosphatase. MAD Group | Baseline, Day 3, Day 8, FU (one week after last dosing) | Blood samples were collected from participants at the indicated timepoints for evaluation of chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. |
| Change From Baseline in Chemistry Laboratory Test Results by Time Point: Aspartate Aminotransferase. MAD Group | Baseline, Day 3, Day 8, FU (one week after last dosing) | Blood samples were collected from participants at the indicated timepoints for evaluation of chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. |
| Change From Baseline in Chemistry Laboratory Test Results by Time Point: Creatine Kinase. MAD Group | Baseline, Day 3, Day 8, FU (one week after last dosing) | Blood samples were collected from participants at the indicated timepoints for evaluation of chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. |
| Change From Baseline in Chemistry Laboratory Test Results by Time Point: Gamma GT. MAD Group | Baseline, Day 3, Day 8, FU (one week after last dosing) | Blood samples were collected from participants at the indicated timepoints for evaluation of chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. |
| Change From Baseline in Chemistry Laboratory Test Results by Time Point: Total Bilirubin. MAD Group | Baseline, Day 3, Day 8, FU (one week after last dosing) | Blood samples were collected from participants at the indicated timepoints for evaluation of chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. |
| Change From Baseline in Chemistry Laboratory Test Results by Time Point: Urea. MAD Group | Baseline, Day 3, Day 8, FU (one week after last dosing) | Blood samples were collected from participants at the indicated timepoints for evaluation of chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. |
| Change From Baseline in Chemistry Laboratory Test Results by Time Point: Creatinine. MAD Group | Baseline, Day 3, Day 8, FU (one week after last dosing) | Blood samples were collected from participants at the indicated timepoints for evaluation of chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. |
| Change From Baseline in Chemistry Laboratory Test Results by Time Point: Sodium. MAD Group | Baseline, Day 3, Day 8, FU (one week after last dosing) | Blood samples were collected from participants at the indicated timepoints for evaluation of chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. |
| Change From Baseline in Chemistry Laboratory Test Results by Time Point: Potassium. MAD Group | Baseline, Day 3, Day 8, FU (one week after last dosing) | Blood samples were collected from participants at the indicated timepoints for evaluation of chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. |
| Change From Baseline in Chemistry Laboratory Test Results by Time Point: Chloride. MAD Group | Baseline, Day 3, Day 8, FU (one week after last dosing) | Blood samples were collected from participants at the indicated timepoints for evaluation of chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. |
| Change From Baseline in Chemistry Laboratory Test Results by Time Point: Calcium (Corrected for Albumin). MAD Group | Baseline, Day 3, Day 8, FU (one week after last dosing) | Blood samples were collected from participants at the indicated timepoints for evaluation of chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. |
| Change From Baseline in Chemistry Laboratory Test Results by Time Point: Uric Acid. MAD Group | Baseline, Day 3, Day 8, FU (one week after last dosing) | Blood samples were collected from participants at the indicated timepoints for evaluation of chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. |
| Change From Baseline in Chemistry Laboratory Test Results by Time Point: Lipase. MAD Group | Baseline, Day 3, Day 8, FU (one week after last dosing) | Blood samples were collected from participants at the indicated timepoints for evaluation of chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. |
| Change From Baseline in Chemistry Laboratory Test Results by Time Point: Alanine Aminotransferase. MAD Group | Baseline, Day 3, Day 8, FU (one week after last dosing) | Blood samples were collected from participants at the indicated timepoints for evaluation of chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. |
| Change From Baseline in Chemistry Laboratory Test Results by Time Point: Phosphate. MAD Group | Baseline, Day 3, Day 8, FU (one week after last dosing) | Blood samples were collected from participants at the indicated timepoints for evaluation of chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. |
| Change From Baseline in Chemistry Laboratory Test Results by Time Point: Human Serum Albumin. MAD Group | Baseline, Day 3, Day 8, FU (one week after last dosing) | Blood samples were collected from participants at the indicated timepoints for evaluation of chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. |
| Change From Baseline in Chemistry Laboratory Test Results by Time Point: Fasting Glucose. MAD Group | Baseline, Day 3, Day 8, FU (one week after last dosing) | Blood samples were collected from participants at the indicated timepoints for evaluation of chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. |
| Change From Baseline in Chemistry Laboratory Test Results by Time Point: Cholesterol. MAD Group | Baseline, Day 3, Day 8, FU (one week after last dosing) | Blood samples were collected from participants at the indicated timepoints for evaluation of chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. |
| Change From Baseline in Chemistry Laboratory Test Results by Time Point: Triglycerides. MAD Group | Baseline, Day 3, Day 8, FU (one week after last dosing) | Blood samples were collected from participants at the indicated timepoints for evaluation of chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. |
| Change From Baseline in Chemistry Laboratory Test Results by Time Point: Low Density Lipoproteins. MAD Group | Baseline, Day 3, Day 8, FU (one week after last dosing) | Blood samples were collected from participants at the indicated timepoints for evaluation of chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. |
| Change From Baseline in Chemistry Laboratory Test Results by Time Point: High Density Lipoproteins. MAD Group | Baseline, Day 3, Day 8, FU (one week after last dosing) | Blood samples were collected from participants at the indicated timepoints for evaluation of chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. |
| Change From Baseline in Chemistry Laboratory Test Results by Time Point: Thyroid-stimulating Hormone. MAD Group | Baseline, Day 3, Day 8, FU (one week after last dosing) | Blood samples were collected from participants at the indicated timepoints for evaluation of chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. |
| Change From Baseline in Chemistry Laboratory Test Results by Time Point: Trilodothyronine (T3). MAD Group | Baseline, Day 3, Day 8, FU (one week after last dosing) | Blood samples were collected from participants at the indicated timepoints for evaluation of chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. |
| Change From Baseline in Chemistry Laboratory Test Results by Time Point: Thyroxine (T4). MAD Group | Baseline, Day 3, Day 8, FU (one week after last dosing) | Blood samples were collected from participants at the indicated timepoints for evaluation of chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. |
| Change From Baseline in Chemistry Laboratory Test Results by Time Point: Bicarbonate. MAD Group | Baseline, Day 3, Day 8, FU (one week after last dosing) | Blood samples were collected from participants at the indicated timepoints for evaluation of chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. |
| Change From Baseline in Chemistry Laboratory Test Results by Time Point: Lactate. MAD Group | Baseline, Day 3, Day 8, FU (one week after last dosing) | Blood samples were collected from participants at the indicated timepoints for evaluation of chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. |
| Phospholipidosis | Day 1, Day 7 | Change from Day 1 to Day 7 in di-docosahexaenoyl (22:6)-bis(monoacylglycerol) phosphate (di-22:6-BMP) and normalized di-22:6-BMP (urine) - MAD |
| MAD: Change From Baseline in ECG Results by Time Point: Corrected QT Interval According to Barret's Formaula (QTcB) | Baseline (pre-dose Day 1), Day1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Follow-up | The baseline ECG recording consists of a triplicate recording (3 recordings of a least 3 complexes within a 5 minute window) prior to dosing on Day 1. For the evaluation the average of the 3 recordings will be taken as baseline. Other ECG recordings will be singlet (one recording of at least 3 complexes) prior to dosing, or around the expected Cmax on Day 1 or 7 for the multiple- dose part. |
| MAD: Change From Baseline in ECG Results by Time Point: P Wave-Q Wave Interval (PQ Interval) | Baseline (pre-dose Day 1), Day1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Follow-up | The baseline ECG recording consists of a triplicate recording (3 recordings of a least 3 complexes within a 5 minute window) prior to dosing on Day 1. For the evaluation of the PQ interval the average of the 3 recordings will be taken as baseline. |
| MAD: Change From Baseline in ECG Results by Time Point: the Interval That Denotes Depolarization of the Ventricles, Between the Beginning of the Q Wave and the End of the S Wave (QRS Interval) | Baseline (pre-dose Day 1), Day1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Follow-up | The baseline ECG recording consists of a triplicate recording (3 recordings of a least 3 complexes within a 5 minute window) prior to dosing on Day 1. For the evaluation the average of the 3 recordings will be taken as baseline. Other ECG recordings will be singlet (one recording of at least 3 complexes) prior to dosing, or around the expected Cmax on Day 1 or 7 for the multiple- dose part. |
| MAD: Change From Baseline in ECG Results by Time Point: QT Interval | Baseline (pre-dose Day 1), Day1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Follow-up | The baseline ECG recording consists of a triplicate recording (3 recordings of a least 3 complexes within a 5 minute window) prior to dosing on Day 1. For the evaluation the average of the 3 recordings will be taken as baseline. Other ECG recordings will be singlet (one recording of at least 3 complexes) prior to dosing, or around the expected Cmax on Day 1 or 7 for the multiple- dose part. |
| SAD: Change From Baseline in ECG Results by Time Point: PQ Interval | Pre-dose, Day 1, Day 7 | The baseline ECG recording consists of a triplicate recording (3 recordings of a least 3 complexes within a 5 minute window) prior to dosing on Day 1. For the evaluation the average of the 3 recordings will be taken as baseline. |
| SAD: Change From Baseline in ECG Results by Time Point: QRS Interval | Pre-dose, Day 1, Day 7 | The baseline ECG recording consists of a triplicate recording (3 recordings of a least 3 complexes within a 5 minute window) prior to dosing on Day 1. For the evaluation the average of the 3 recordings will be taken as baseline. |
| SAD: Change From Baseline in ECG Results by Time Point: QT Interval | Pre-dose, Day 1, Day 7 | The baseline ECG recording consists of a triplicate recording (3 recordings of a least 3 complexes within a 5 minute window) prior to dosing on Day 1. For the evaluation the average of the 3 recordings will be taken as baseline. |
| SAD: Change From Baseline in ECG Results by Time Point: QTcB Interval | Pre-dose, Day1, Day 7 | The baseline ECG recording consists of a triplicate recording (3 recordings of a least 3 complexes within a 5 minute window) prior to dosing on Day 1. For the evaluation the average of the 3 recordings will be taken as baseline. |
| Terminal Elimination Half-life (T1/2) of KH176 Over 24 Hours: SAD | Pre-dose (5 min before dosing) and 0.5, 1, 1.5, 2, 3, 6, 8, 12, and 24 hours post-dose | Plasma concentrations of KH176 were analysed after single dose administration of doses 10mg, 30mg, 100mg (with and without food), 300mg, 800mg, 2000mg b.i.d. |
| Terminal Elimination Half-life (T1/2) of KH183: SAD | Pre-dose (5 min before dosing) and 0.5, 1, 1.5, 2, 3, 6, 8, 12, and 24 hours post-dose | Plasma concentrations of KH183 were analysed after single dose administration of doses 10mg, 30mg, 100mg (with and without food) , 300mg, 800mg, 2000mg b.i.d. |
| Maximum Concentration (Cmax) of KH176: SAD Group | Pre-dose (5 min before dosing) and 0.5, 1, 1.5, 2, 3, 6, 8, 12, and 24 hours post-dose | Plasma concentrations of KH176 were analysed after single dose administration of doses 10mg, 30mg, 100mg (with and without food), 300mg, 800mg, 2000mg b.i.d. |
| Maximum Concentration (Cmax) of KH183 Over 24 Hours: SAD | Pre-dose (5 min before dosing) and 0.5, 1, 1.5, 2, 3, 6, 8, 12, and 24 hours post-dose | Plasma concentrations of KH183 were analysed after single dose administration of doses 10mg, 30mg, 100mg (with and without food) , 300mg, 800mg, 2000mg b.i.d. |
| Maximum Concentration (Cmax) of KH183 (Active Metabolite of KH176): MAD Group | Predose at Day 1, 2, 4, 7, and post-dose at Day 1 and Day 7 at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours | Plasma concentrations of KH183 were analysed after multiple-dose administration of doses of 100, 200 and 400 mg b.i.d.: Cmax was obtained directly from the concentration-time data. |
| Maximum Concentration (Cmax) of KH176: MAD | pre-dose at Day 1, 2, 4, 7, and post-dose at Day 1 and Day 7 at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours | Plasma concentrations of KH176 were analysed after multiple-dose administration of doses of 100, 200 and 400 mg b.i.d. |
| Time to Maximum Concentration (Tmax) of KH176 Over 24 Hours: SAD | Pre-dose (5 min before dosing) and 0.5, 1, 1.5, 2, 3, 6, 8, 12, and 24 hours post-dose | Plasma concentrations of KH176 were analysed after single dose administration of doses 10mg, 30mg, 100mg (with and without food), 300mg, 800mg, 2000mg b.i.d. |
| Time to Reach Peak Plasma Concentration (Tmax) of KH183: SAD | Pre-dose (5 min before dosing) and 0.5, 1, 1.5, 2, 3, 6, 8, 12, and 24 hours post-dose | Plasma concentrations of KH183 were analysed after single dose administration of doses 10mg, 30mg, 100mg (with and without food), 300mg, 800mg, 2000mg b.i.d. |
| Time to Maximum Concentration (Tmax) of KH176 at Day 1, Day 7: MAD Group | pre-dose at Day 1, 2, 4, 7, and post-dose at Day 1 and Day 7 at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours | Plasma concentrations of KH176 were analysed after multiple-dose administration of doses of 100, 200 and 400 mg b.i.d. |
| Time to Maximum Concentration (Tmax) of KH183 (Active Metabolite of KH176): MAD Group | Predose at Day 1, 2, 4, 7, and post-dose at Day 1 and Day 7 at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours | Plasma concentrations of KH183 were analysed after multiple-dose administration of doses of 100, 200 and 400 mg b.i.d.. tmax was obtained directly from the concentration-time data. |
| Accumulation Factor (Racc) of KH176 Over 7 Days: MAD Group | Pre-dose at Day 1, 2, 4, 7, and post-dose at Day 1 and Day 7 at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours | Plasma concentrations of KH176 were analysed after multiple-dose administration of doses of 100, 200 and 400 mg b.i.d.. Racc was calculated as follows: AUCtau day 7/ AUCtau day 1. |
| Accumulation Factor (Racc) of KH183 (Active Metabolite of KH176): MAD Group | Predose at Day 1, 2, 4, 7, and post-dose at Day 1 and Day 7 at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours | Plasma concentrations of KH183 were analysed after multiple-dose administration of doses of 100, 200 and 400 mg b.i.d.: Accumulation factor was calculated as follows: AUCtau day 7/ AUCtau day 1. |
| Area Under the Plasma Concentration Versus Time Curve (AUClast) of KH183: SAD Group | Pre-dose (5 min before dosing) and 0.5, 1, 1.5, 2, 3, 6, 8, 12, and 24 hours post-dose | Plasma concentrations of KH183 were analysed after single dose administration of doses 10mg, 30mg, 100mg (with and without food) , 300mg, 800mg, 2000mg b.i.d. |
| Area Under the Plasma Concentration Versus Time Curve (AUClast) of KH176: SAD Group | pre-dose (5 min before dosing) and 0.5, 1, 1.5, 2, 3, 6, 8, 12, and 24 hours post-dose | Plasma concentrations of KH176 were analysed after single dose administration of doses 10mg, 30mg, 100mg (with and without food), 300mg, 800mg, 2000mg b.i.d. |
| Area Under the Plasma Concentration-time Curve (AUCtau) of KH176: MAD Group: | Pre-dose at Day 1, 2, 4, 7, and post-dose at Day 1 and Day 7 at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours | Plasma concentrations of KH176 were analysed after multiple-dose administration of doses of 100, 200 and 400 mg b.i.d. |
| Area Under the Plasma Concentration-time Curve During a Dose Interval (AUCtau) of KH183 (Active Metabolite of KH176): MAD Group | Predose at Day 1, 2, 4, 7, and post-dose at Day 1 and Day 7 at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours | Plasma concentrations of KH183 were analysed after multiple-dose administration of doses of 100, 200 and 400 mg b.i.d. |
| Area Under the Plasma Concentration-time Curve From Time Zero Until Infinity (AUCl0-inf) of KH183: SAD | Pre-dose (5 min before dosing) and 0.5, 1, 1.5, 2, 3, 6, 8, 12, and 24 hours post-dose | Plasma concentrations of KH183 were analysed after single dose administration of doses 10mg, 30mg, 100mg (with and without food) , 300mg, 800mg, 2000mg b.i.d. |
| Area Under the Plasma Concentration-time Curve From Time Zero Until Infinity (AUCl0-inf) of KH176: SAD | Pre-dose (5 min before dosing) and 0.5, 1, 1.5, 2, 3, 6, 8, 12, and 24 hours post-dose | Plasma concentrations of KH176 were analysed after single dose administration of doses 10mg, 30mg, 100mg (with and without food) , 300mg, 800mg, 2000mg b.i.d. |
| KH176: Percentage of Administered Dose Excreted in Urine: SAD | 24 hours post-dose | Urine concentrations of KH176 were analysed after single dose administration of doses 10mg, 30mg, 100mg (with and without food), 300mg, 800mg, 2000mg b.i.d. |
| KH183: Percentage of Administered Dose Excreted in Urine: SAD | 24 hours post-dose | Urine concentrations of KH176 were analysed after single dose administration of doses 10mg, 30mg, 100mg (with and without food), 300mg, 800mg, 2000mg b.i.d. |
| KH176 + KH183: Percentage of Administered Dose Excreted in Urine: SAD | 24 hours post-dose | Urine concentrations of KH176 were analysed after single dose administration of doses 10mg, 30mg, 100mg (with and without food), 300mg, 800mg, 2000mg b.i.d. |
| KH176: Percentage of Administered Dose Excreted in Urine: MAD | Day 7 post dose | Urine concentrations of KH176 were analysed after multiple-dose administration of doses of 100, 200 and 400 mg b.i.d. |
| KH183: Percentage of Administered Dose Excreted in Urine: MAD | Post dose Day 7 | Urine concentrations of KH183 were analysed after multiple-dose administration of doses of 100, 200 and 400 mg b.i.d. |
Countries
Belgium
Participant flow
Recruitment details
All studies were conducted at the Drug Research Unit Ghent. Participants agreed to stay in the Drug Research Unit during the first 24 h after dosing (SAD) and during Day 8 (MAD).
Participants by arm
| Arm | Count |
|---|---|
| SAD Group I SAD group I: 10mg, 100mg, 800mg | 7 |
| SAD Group II SAD group II: 30mg, 300mg, 2000mg | 7 |
| MAD Group III MAD group III:100mg bis in die (BID) | 4 |
| MAD Group IV MAD group IV: 200mg BID | 4 |
| MAD Group V MAD group V: 400mg BID | 4 |
| Placebo Placebo group | 6 |
| Total | 32 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 1 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | SAD Group I | Total | Placebo | MAD Group V | MAD Group IV | MAD Group III | SAD Group II |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 30.4 years STANDARD_DEVIATION 10.5 | 40.0 years STANDARD_DEVIATION 4 | 44.7 years STANDARD_DEVIATION 9.8 | 44.0 years STANDARD_DEVIATION 8.2 | 34.5 years STANDARD_DEVIATION 11.6 | 40.8 years STANDARD_DEVIATION 13 | 32.0 years STANDARD_DEVIATION 11.3 |
| BMI | 26.09 kg/m^2 STANDARD_DEVIATION 2.51 | 24.0 kg/m^2 STANDARD_DEVIATION 4 | 23.43 kg/m^2 STANDARD_DEVIATION 1.98 | 26.28 kg/m^2 STANDARD_DEVIATION 1.67 | 23.60 kg/m^2 STANDARD_DEVIATION 3.82 | 26.10 kg/m^2 STANDARD_DEVIATION 2.74 | 24.01 kg/m^2 STANDARD_DEVIATION 4.01 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 3 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants | 29 Participants | 5 Participants | 4 Participants | 3 Participants | 4 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Height | 178.07 cm STANDARD_DEVIATION 6.56 | 184.0 cm STANDARD_DEVIATION 4 | 175.55 cm STANDARD_DEVIATION 8.25 | 175.70 cm STANDARD_DEVIATION 3.18 | 181.75 cm STANDARD_DEVIATION 5.25 | 184.63 cm STANDARD_DEVIATION 2.81 | 176.01 cm STANDARD_DEVIATION 8.11 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 7 Participants | 32 Participants | 6 Participants | 4 Participants | 4 Participants | 4 Participants | 7 Participants |
| Region of Enrollment Belgium | 7 participants | 32 participants | 6 participants | 4 participants | 4 participants | 4 participants | 7 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 7 Participants | 32 Participants | 6 Participants | 4 Participants | 4 Participants | 4 Participants | 7 Participants |
| Weight | 82.86 kg STANDARD_DEVIATION 10.56 | 80.0 kg STANDARD_DEVIATION 8 | 72.03 kg STANDARD_DEVIATION 6.06 | 81.10 kg STANDARD_DEVIATION 4.82 | 77.85 kg STANDARD_DEVIATION 11.96 | 89.05 kg STANDARD_DEVIATION 11.84 | 74.29 kg STANDARD_DEVIATION 12.61 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 6 | 0 / 4 | 0 / 4 | 0 / 4 | 0 / 4 | 0 / 4 | 0 / 4 | 0 / 2 | 0 / 4 | 0 / 4 | 0 / 4 | 0 / 4 | 0 / 6 |
| other Total, other adverse events | 2 / 6 | 1 / 6 | 2 / 4 | 3 / 4 | 4 / 4 | 1 / 4 | 0 / 4 | 4 / 4 | 1 / 2 | 1 / 4 | 3 / 4 | 3 / 4 | 4 / 4 | 5 / 6 |
| serious Total, serious adverse events | 0 / 6 | 0 / 6 | 0 / 4 | 0 / 4 | 0 / 4 | 0 / 4 | 0 / 4 | 0 / 4 | 0 / 2 | 0 / 4 | 0 / 4 | 0 / 4 | 0 / 4 | 0 / 6 |
Outcome results
Primary
Accumulation Factor (Racc) of KH176 Over 7 Days: MAD Group
Plasma concentrations of KH176 were analysed after multiple-dose administration of doses of 100, 200 and 400 mg b.i.d.. Racc was calculated as follows: AUCtau day 7/ AUCtau day 1.
Time frame: Pre-dose at Day 1, 2, 4, 7, and post-dose at Day 1 and Day 7 at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours
Population: Per protocol set
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Group I Placebo | Accumulation Factor (Racc) of KH176 Over 7 Days: MAD Group | 2.52 ratio | Geometric Coefficient of Variation 31.2 |
| Group II Placebo | Accumulation Factor (Racc) of KH176 Over 7 Days: MAD Group | 2.65 ratio | Geometric Coefficient of Variation 2.5 |
| SAD Group I 10mg | Accumulation Factor (Racc) of KH176 Over 7 Days: MAD Group | 2.17 ratio | Geometric Coefficient of Variation 14.4 |
Primary
Accumulation Factor (Racc) of KH183 (Active Metabolite of KH176): MAD Group
Plasma concentrations of KH183 were analysed after multiple-dose administration of doses of 100, 200 and 400 mg b.i.d.: Accumulation factor was calculated as follows: AUCtau day 7/ AUCtau day 1.
Time frame: Predose at Day 1, 2, 4, 7, and post-dose at Day 1 and Day 7 at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours
Population: Per protocol set. The placebo subjects were excluded from the PK analysis per-protocol set.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Group I Placebo | Accumulation Factor (Racc) of KH183 (Active Metabolite of KH176): MAD Group | 1.86 ratio | Geometric Coefficient of Variation 46.7 |
| Group II Placebo | Accumulation Factor (Racc) of KH183 (Active Metabolite of KH176): MAD Group | 1.32 ratio | Geometric Coefficient of Variation 13.1 |
| SAD Group I 10mg | Accumulation Factor (Racc) of KH183 (Active Metabolite of KH176): MAD Group | 1.19 ratio | Geometric Coefficient of Variation 24.7 |
Primary
Area Under the Plasma Concentration-time Curve (AUCtau) of KH176: MAD Group:
Plasma concentrations of KH176 were analysed after multiple-dose administration of doses of 100, 200 and 400 mg b.i.d.
Time frame: Pre-dose at Day 1, 2, 4, 7, and post-dose at Day 1 and Day 7 at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours
Population: Per protocol set
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Group I Placebo | Area Under the Plasma Concentration-time Curve (AUCtau) of KH176: MAD Group: | Day 1 | 1090 h*ng/mL | Geometric Coefficient of Variation 49.3 |
| Group I Placebo | Area Under the Plasma Concentration-time Curve (AUCtau) of KH176: MAD Group: | Day 7 | 2760 h*ng/mL | Geometric Coefficient of Variation 22.6 |
| Group II Placebo | Area Under the Plasma Concentration-time Curve (AUCtau) of KH176: MAD Group: | Day 1 | 2250 h*ng/mL | Geometric Coefficient of Variation 26.1 |
| Group II Placebo | Area Under the Plasma Concentration-time Curve (AUCtau) of KH176: MAD Group: | Day 7 | 5960 h*ng/mL | Geometric Coefficient of Variation 26.8 |
| SAD Group I 10mg | Area Under the Plasma Concentration-time Curve (AUCtau) of KH176: MAD Group: | Day 1 | 6890 h*ng/mL | Geometric Coefficient of Variation 19.2 |
| SAD Group I 10mg | Area Under the Plasma Concentration-time Curve (AUCtau) of KH176: MAD Group: | Day 7 | 14900 h*ng/mL | Geometric Coefficient of Variation 28.2 |
Primary
Area Under the Plasma Concentration-time Curve During a Dose Interval (AUCtau) of KH183 (Active Metabolite of KH176): MAD Group
Plasma concentrations of KH183 were analysed after multiple-dose administration of doses of 100, 200 and 400 mg b.i.d.
Time frame: Predose at Day 1, 2, 4, 7, and post-dose at Day 1 and Day 7 at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours
Population: Per protocol set. The placebo subjects were excluded from the PharmaocoKinetics (PK) analysis per-protocol set.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Group I Placebo | Area Under the Plasma Concentration-time Curve During a Dose Interval (AUCtau) of KH183 (Active Metabolite of KH176): MAD Group | Day 1 | 702 h*ng/mL | Geometric Coefficient of Variation 29.2 |
| Group I Placebo | Area Under the Plasma Concentration-time Curve During a Dose Interval (AUCtau) of KH183 (Active Metabolite of KH176): MAD Group | Day 7 | 1310 h*ng/mL | Geometric Coefficient of Variation 29.5 |
| Group II Placebo | Area Under the Plasma Concentration-time Curve During a Dose Interval (AUCtau) of KH183 (Active Metabolite of KH176): MAD Group | Day 1 | 1680 h*ng/mL | Geometric Coefficient of Variation 21 |
| Group II Placebo | Area Under the Plasma Concentration-time Curve During a Dose Interval (AUCtau) of KH183 (Active Metabolite of KH176): MAD Group | Day 7 | 2220 h*ng/mL | Geometric Coefficient of Variation 12.7 |
| SAD Group I 10mg | Area Under the Plasma Concentration-time Curve During a Dose Interval (AUCtau) of KH183 (Active Metabolite of KH176): MAD Group | Day 1 | 3600 h*ng/mL | Geometric Coefficient of Variation 11.1 |
| SAD Group I 10mg | Area Under the Plasma Concentration-time Curve During a Dose Interval (AUCtau) of KH183 (Active Metabolite of KH176): MAD Group | Day 7 | 4270 h*ng/mL | Geometric Coefficient of Variation 30.5 |
Primary
Area Under the Plasma Concentration-time Curve From Time Zero Until Infinity (AUCl0-inf) of KH176: SAD
Plasma concentrations of KH176 were analysed after single dose administration of doses 10mg, 30mg, 100mg (with and without food) , 300mg, 800mg, 2000mg b.i.d.
Time frame: Pre-dose (5 min before dosing) and 0.5, 1, 1.5, 2, 3, 6, 8, 12, and 24 hours post-dose
Population: Per protocol set
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Group I Placebo | Area Under the Plasma Concentration-time Curve From Time Zero Until Infinity (AUCl0-inf) of KH176: SAD | 0 h*ng/mL | Geometric Coefficient of Variation 0 |
| Group II Placebo | Area Under the Plasma Concentration-time Curve From Time Zero Until Infinity (AUCl0-inf) of KH176: SAD | 474 h*ng/mL | Geometric Coefficient of Variation 8.39 |
| SAD Group I 10mg | Area Under the Plasma Concentration-time Curve From Time Zero Until Infinity (AUCl0-inf) of KH176: SAD | 1540 h*ng/mL | Geometric Coefficient of Variation 13.1 |
| SAD Group II 30mg | Area Under the Plasma Concentration-time Curve From Time Zero Until Infinity (AUCl0-inf) of KH176: SAD | 7500 h*ng/mL | Geometric Coefficient of Variation 19.1 |
| SAD Group I 100mg | Area Under the Plasma Concentration-time Curve From Time Zero Until Infinity (AUCl0-inf) of KH176: SAD | 25800 h*ng/mL | Geometric Coefficient of Variation 33.9 |
| SAD Group II 300mg | Area Under the Plasma Concentration-time Curve From Time Zero Until Infinity (AUCl0-inf) of KH176: SAD | 79100 h*ng/mL | Geometric Coefficient of Variation 8.82 |
| SAD Group I 800mg | Area Under the Plasma Concentration-time Curve From Time Zero Until Infinity (AUCl0-inf) of KH176: SAD | 1970 h*ng/mL | Geometric Coefficient of Variation 1.04 |
Primary
Area Under the Plasma Concentration-time Curve From Time Zero Until Infinity (AUCl0-inf) of KH183: SAD
Plasma concentrations of KH183 were analysed after single dose administration of doses 10mg, 30mg, 100mg (with and without food) , 300mg, 800mg, 2000mg b.i.d.
Time frame: Pre-dose (5 min before dosing) and 0.5, 1, 1.5, 2, 3, 6, 8, 12, and 24 hours post-dose
Population: Per protocol set
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Group I Placebo | Area Under the Plasma Concentration-time Curve From Time Zero Until Infinity (AUCl0-inf) of KH183: SAD | 234 h*ng/mL | Geometric Coefficient of Variation 26.7 |
| Group II Placebo | Area Under the Plasma Concentration-time Curve From Time Zero Until Infinity (AUCl0-inf) of KH183: SAD | 881 h*ng/mL | Geometric Coefficient of Variation 19.6 |
| SAD Group I 10mg | Area Under the Plasma Concentration-time Curve From Time Zero Until Infinity (AUCl0-inf) of KH183: SAD | 2690 h*ng/mL | Geometric Coefficient of Variation 38.4 |
| SAD Group II 30mg | Area Under the Plasma Concentration-time Curve From Time Zero Until Infinity (AUCl0-inf) of KH183: SAD | 6690 h*ng/mL | Geometric Coefficient of Variation 11 |
| SAD Group I 100mg | Area Under the Plasma Concentration-time Curve From Time Zero Until Infinity (AUCl0-inf) of KH183: SAD | 18700 h*ng/mL | Geometric Coefficient of Variation 26.7 |
| SAD Group II 300mg | Area Under the Plasma Concentration-time Curve From Time Zero Until Infinity (AUCl0-inf) of KH183: SAD | 41300 h*ng/mL | Geometric Coefficient of Variation 10.5 |
| SAD Group I 800mg | Area Under the Plasma Concentration-time Curve From Time Zero Until Infinity (AUCl0-inf) of KH183: SAD | 2410 h*ng/mL | Geometric Coefficient of Variation 29.1 |
Primary
Area Under the Plasma Concentration Versus Time Curve (AUClast) of KH176: SAD Group
Plasma concentrations of KH176 were analysed after single dose administration of doses 10mg, 30mg, 100mg (with and without food), 300mg, 800mg, 2000mg b.i.d.
Time frame: pre-dose (5 min before dosing) and 0.5, 1, 1.5, 2, 3, 6, 8, 12, and 24 hours post-dose
Population: Per protocol set
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Group I Placebo | Area Under the Plasma Concentration Versus Time Curve (AUClast) of KH176: SAD Group | 75 h*ng/mL | Geometric Coefficient of Variation 14.8 |
| Group II Placebo | Area Under the Plasma Concentration Versus Time Curve (AUClast) of KH176: SAD Group | 389 h*ng/mL | Geometric Coefficient of Variation 8.16 |
| SAD Group I 10mg | Area Under the Plasma Concentration Versus Time Curve (AUClast) of KH176: SAD Group | 1310 h*ng/mL | Geometric Coefficient of Variation 16.7 |
| SAD Group II 30mg | Area Under the Plasma Concentration Versus Time Curve (AUClast) of KH176: SAD Group | 6320 h*ng/mL | Geometric Coefficient of Variation 20.2 |
| SAD Group I 100mg | Area Under the Plasma Concentration Versus Time Curve (AUClast) of KH176: SAD Group | 21000 h*ng/mL | Geometric Coefficient of Variation 27.5 |
| SAD Group II 300mg | Area Under the Plasma Concentration Versus Time Curve (AUClast) of KH176: SAD Group | 61200 h*ng/mL | Geometric Coefficient of Variation 9.07 |
| SAD Group I 800mg | Area Under the Plasma Concentration Versus Time Curve (AUClast) of KH176: SAD Group | 1650 h*ng/mL | Geometric Coefficient of Variation 1.67 |
Primary
Area Under the Plasma Concentration Versus Time Curve (AUClast) of KH183: SAD Group
Plasma concentrations of KH183 were analysed after single dose administration of doses 10mg, 30mg, 100mg (with and without food) , 300mg, 800mg, 2000mg b.i.d.
Time frame: Pre-dose (5 min before dosing) and 0.5, 1, 1.5, 2, 3, 6, 8, 12, and 24 hours post-dose
Population: Per protocol set
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Group I Placebo | Area Under the Plasma Concentration Versus Time Curve (AUClast) of KH183: SAD Group | 151 h*ng/mL | Geometric Coefficient of Variation 26.7 |
| Group II Placebo | Area Under the Plasma Concentration Versus Time Curve (AUClast) of KH183: SAD Group | 547 h*ng/mL | Geometric Coefficient of Variation 12.4 |
| SAD Group I 10mg | Area Under the Plasma Concentration Versus Time Curve (AUClast) of KH183: SAD Group | 1810 h*ng/mL | Geometric Coefficient of Variation 37.4 |
| SAD Group II 30mg | Area Under the Plasma Concentration Versus Time Curve (AUClast) of KH183: SAD Group | 4830 h*ng/mL | Geometric Coefficient of Variation 11.8 |
| SAD Group I 100mg | Area Under the Plasma Concentration Versus Time Curve (AUClast) of KH183: SAD Group | 11700 h*ng/mL | Geometric Coefficient of Variation 20.2 |
| SAD Group II 300mg | Area Under the Plasma Concentration Versus Time Curve (AUClast) of KH183: SAD Group | 23900 h*ng/mL | Geometric Coefficient of Variation 22.2 |
| SAD Group I 800mg | Area Under the Plasma Concentration Versus Time Curve (AUClast) of KH183: SAD Group | 1590 h*ng/mL | Geometric Coefficient of Variation 26.1 |
Primary
Change From Baseline in Chemistry Laboratory Test Results by Time Point: Alanine Aminotransferase. MAD Group
Blood samples were collected from participants at the indicated timepoints for evaluation of chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time frame: Baseline, Day 3, Day 8, FU (one week after last dosing)
Population: The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Alanine Aminotransferase. MAD Group | Baseline (pre-dose Day 1) | 25.3 U/L | Standard Deviation 9.7 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Alanine Aminotransferase. MAD Group | Change from BL at Day 3 | 0.0 U/L | Standard Deviation 5.9 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Alanine Aminotransferase. MAD Group | Change from BL at Day 8 | -1.8 U/L | Standard Deviation 12.9 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Alanine Aminotransferase. MAD Group | Change from BL at FU | 1.3 U/L | Standard Deviation 11.4 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Alanine Aminotransferase. MAD Group | Change from BL at Day 3 | -0.3 U/L | Standard Deviation 2.2 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Alanine Aminotransferase. MAD Group | Change from BL at Day 8 | 2.3 U/L | Standard Deviation 2.6 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Alanine Aminotransferase. MAD Group | Change from BL at FU | 6.3 U/L | Standard Deviation 8.3 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Alanine Aminotransferase. MAD Group | Baseline (pre-dose Day 1) | 21.3 U/L | Standard Deviation 17.4 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Alanine Aminotransferase. MAD Group | Change from BL at Day 8 | 0.3 U/L | Standard Deviation 5.4 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Alanine Aminotransferase. MAD Group | Change from BL at Day 3 | -1.3 U/L | Standard Deviation 0.5 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Alanine Aminotransferase. MAD Group | Change from BL at FU | 4.8 U/L | Standard Deviation 7.9 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Alanine Aminotransferase. MAD Group | Baseline (pre-dose Day 1) | 20.5 U/L | Standard Deviation 6.8 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Alanine Aminotransferase. MAD Group | Change from BL at FU | 2.3 U/L | Standard Deviation 6.9 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Alanine Aminotransferase. MAD Group | Change from BL at Day 3 | 2.0 U/L | Standard Deviation 4.2 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Alanine Aminotransferase. MAD Group | Baseline (pre-dose Day 1) | 22.3 U/L | Standard Deviation 5.2 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Alanine Aminotransferase. MAD Group | Change from BL at Day 8 | 2.8 U/L | Standard Deviation 5.9 |
Primary
Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Alanine Aminotransferase. SAD Group
Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time frame: Baseline (pre-dose Day 1), 24h post dose, FU (7 days post dose)
Population: The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Alanine Aminotransferase. SAD Group | Baseline (pre-dose Day 1) | 20.2 U/L | Standard Deviation 11.3 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Alanine Aminotransferase. SAD Group | Change from BL at FU | -1.0 U/L | Standard Deviation 4.5 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Alanine Aminotransferase. SAD Group | Change from BL at 24h | -1.2 U/L | Standard Deviation 2.2 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Alanine Aminotransferase. SAD Group | Change from BL at 24h | -0.3 U/L | Standard Deviation 3.2 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Alanine Aminotransferase. SAD Group | Change from BL at FU | 5.7 U/L | Standard Deviation 17.7 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Alanine Aminotransferase. SAD Group | Baseline (pre-dose Day 1) | 17.2 U/L | Standard Deviation 6.9 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Alanine Aminotransferase. SAD Group | Change from BL at FU | 2.3 U/L | Standard Deviation 7.8 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Alanine Aminotransferase. SAD Group | Baseline (pre-dose Day 1) | 19.3 U/L | Standard Deviation 3.2 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Alanine Aminotransferase. SAD Group | Change from BL at 24h | 0.8 U/L | Standard Deviation 2.9 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Alanine Aminotransferase. SAD Group | Change from BL at FU | 8.3 U/L | Standard Deviation 18 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Alanine Aminotransferase. SAD Group | Baseline (pre-dose Day 1) | 20.0 U/L | Standard Deviation 10.1 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Alanine Aminotransferase. SAD Group | Change from BL at 24h | -1.3 U/L | Standard Deviation 3.5 |
| SAD Group I 100mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Alanine Aminotransferase. SAD Group | Baseline (pre-dose Day 1) | 15.0 U/L | Standard Deviation 6.9 |
| SAD Group I 100mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Alanine Aminotransferase. SAD Group | Change from BL at 24h | 1.3 U/L | Standard Deviation 1.3 |
| SAD Group I 100mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Alanine Aminotransferase. SAD Group | Change from BL at FU | 1.8 U/L | Standard Deviation 2.6 |
| SAD Group II 300mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Alanine Aminotransferase. SAD Group | Change from BL at 24h | -0.3 U/L | Standard Deviation 2.8 |
| SAD Group II 300mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Alanine Aminotransferase. SAD Group | Baseline (pre-dose Day 1) | 19.3 U/L | Standard Deviation 6.6 |
| SAD Group II 300mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Alanine Aminotransferase. SAD Group | Change from BL at FU | 6.0 U/L | Standard Deviation 21.5 |
| SAD Group I 800mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Alanine Aminotransferase. SAD Group | Baseline (pre-dose Day 1) | 22.8 U/L | Standard Deviation 12.8 |
| SAD Group I 800mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Alanine Aminotransferase. SAD Group | Change from BL at FU | -2.3 U/L | Standard Deviation 5.7 |
| SAD Group I 800mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Alanine Aminotransferase. SAD Group | Change from BL at 24h | -2.0 U/L | Standard Deviation 3.6 |
| SAD Group II 2000mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Alanine Aminotransferase. SAD Group | Change from BL at 24h | 0.3 U/L | Standard Deviation 3.9 |
| SAD Group II 2000mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Alanine Aminotransferase. SAD Group | Baseline (pre-dose Day 1) | 17.8 U/L | Standard Deviation 6.8 |
| SAD Group II 2000mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Alanine Aminotransferase. SAD Group | Change from BL at FU | -1.0 U/L | Standard Deviation 2.9 |
| Group I Placebo + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Alanine Aminotransferase. SAD Group | Change from BL at 24h | 1.5 U/L | Standard Deviation 2.1 |
| Group I Placebo + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Alanine Aminotransferase. SAD Group | Baseline (pre-dose Day 1) | 19.0 U/L | Standard Deviation 1.4 |
| Group I Placebo + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Alanine Aminotransferase. SAD Group | Change from BL at FU | 7.5 U/L | Standard Deviation 9.2 |
| Group I 100mg + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Alanine Aminotransferase. SAD Group | Baseline (pre-dose Day 1) | 15.0 U/L | Standard Deviation 5.7 |
| Group I 100mg + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Alanine Aminotransferase. SAD Group | Change from BL at FU | 1.8 U/L | Standard Deviation 2.1 |
| Group I 100mg + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Alanine Aminotransferase. SAD Group | Change from BL at 24h | 1.5 U/L | Standard Deviation 1 |
Primary
Change From Baseline in Chemistry Laboratory Test Results by Time Point: Alkaline Phosphatase. MAD Group
Blood samples were collected from participants at the indicated timepoints for evaluation of chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time frame: Baseline, Day 3, Day 8, FU (one week after last dosing)
Population: The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Alkaline Phosphatase. MAD Group | Baseline (pre-dose Day 1) | 66.0 U/L | Standard Deviation 16.1 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Alkaline Phosphatase. MAD Group | Change from BL at Day 3 | 7.3 U/L | Standard Deviation 6.7 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Alkaline Phosphatase. MAD Group | Change from BL at Day 8 | 13.0 U/L | Standard Deviation 9.7 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Alkaline Phosphatase. MAD Group | Change from BL at FU | 9.0 U/L | Standard Deviation 13.3 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Alkaline Phosphatase. MAD Group | Change from BL at Day 3 | 2.0 U/L | Standard Deviation 1.4 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Alkaline Phosphatase. MAD Group | Change from BL at Day 8 | 5.0 U/L | Standard Deviation 4.2 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Alkaline Phosphatase. MAD Group | Change from BL at FU | 10.8 U/L | Standard Deviation 4.6 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Alkaline Phosphatase. MAD Group | Baseline (pre-dose Day 1) | 67.3 U/L | Standard Deviation 10.7 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Alkaline Phosphatase. MAD Group | Change from BL at Day 8 | 6.0 U/L | Standard Deviation 6.4 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Alkaline Phosphatase. MAD Group | Change from BL at Day 3 | 1.5 U/L | Standard Deviation 3.9 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Alkaline Phosphatase. MAD Group | Change from BL at FU | 9.8 U/L | Standard Deviation 5.2 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Alkaline Phosphatase. MAD Group | Baseline (pre-dose Day 1) | 55.3 U/L | Standard Deviation 7.3 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Alkaline Phosphatase. MAD Group | Change from BL at FU | 3.3 U/L | Standard Deviation 4 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Alkaline Phosphatase. MAD Group | Change from BL at Day 3 | 1.8 U/L | Standard Deviation 1.8 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Alkaline Phosphatase. MAD Group | Baseline (pre-dose Day 1) | 52.3 U/L | Standard Deviation 9.5 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Alkaline Phosphatase. MAD Group | Change from BL at Day 8 | 3.3 U/L | Standard Deviation 1.9 |
Primary
Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Alkaline Phosphatase. SAD Group
Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time frame: Baseline (pre-dose Day 1), 24h post dose, FU (7 days post dose)
Population: The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Alkaline Phosphatase. SAD Group | Change from BL at FU | -1.5 U/L | Standard Deviation 9 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Alkaline Phosphatase. SAD Group | Baseline (pre-dose Day 1) | 62.0 U/L | Standard Deviation 18.6 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Alkaline Phosphatase. SAD Group | Change from BL at 24h | -0.2 U/L | Standard Deviation 3 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Alkaline Phosphatase. SAD Group | Change from BL at FU | 1.7 U/L | Standard Deviation 6.3 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Alkaline Phosphatase. SAD Group | Baseline (pre-dose Day 1) | 64.0 U/L | Standard Deviation 19.8 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Alkaline Phosphatase. SAD Group | Change from BL at 24h | 1.7 U/L | Standard Deviation 3.5 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Alkaline Phosphatase. SAD Group | Baseline (pre-dose Day 1) | 66.0 U/L | Standard Deviation 18.5 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Alkaline Phosphatase. SAD Group | Change from BL at FU | 1.8 U/L | Standard Deviation 3.5 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Alkaline Phosphatase. SAD Group | Change from BL at 24h | 1.0 U/L | Standard Deviation 2.8 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Alkaline Phosphatase. SAD Group | Baseline (pre-dose Day 1) | 75.0 U/L | Standard Deviation 32.2 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Alkaline Phosphatase. SAD Group | Change from BL at 24h | -1.8 U/L | Standard Deviation 8.1 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Alkaline Phosphatase. SAD Group | Change from BL at FU | -3.8 U/L | Standard Deviation 18.2 |
| SAD Group I 100mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Alkaline Phosphatase. SAD Group | Change from BL at FU | 1.5 U/L | Standard Deviation 3.4 |
| SAD Group I 100mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Alkaline Phosphatase. SAD Group | Change from BL at 24h | 1.0 U/L | Standard Deviation 4.7 |
| SAD Group I 100mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Alkaline Phosphatase. SAD Group | Baseline (pre-dose Day 1) | 66.0 U/L | Standard Deviation 25 |
| SAD Group II 300mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Alkaline Phosphatase. SAD Group | Change from BL at 24h | 3.8 U/L | Standard Deviation 4.6 |
| SAD Group II 300mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Alkaline Phosphatase. SAD Group | Baseline (pre-dose Day 1) | 68.3 U/L | Standard Deviation 28 |
| SAD Group II 300mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Alkaline Phosphatase. SAD Group | Change from BL at FU | -1.5 U/L | Standard Deviation 11.3 |
| SAD Group I 800mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Alkaline Phosphatase. SAD Group | Baseline (pre-dose Day 1) | 53.3 U/L | Standard Deviation 10.2 |
| SAD Group I 800mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Alkaline Phosphatase. SAD Group | Change from BL at FU | -2.0 U/L | Standard Deviation 5.4 |
| SAD Group I 800mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Alkaline Phosphatase. SAD Group | Change from BL at 24h | 1.3 U/L | Standard Deviation 3.6 |
| SAD Group II 2000mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Alkaline Phosphatase. SAD Group | Change from BL at 24h | 6.8 U/L | Standard Deviation 3.5 |
| SAD Group II 2000mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Alkaline Phosphatase. SAD Group | Baseline (pre-dose Day 1) | 49.0 U/L | Standard Deviation 8.9 |
| SAD Group II 2000mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Alkaline Phosphatase. SAD Group | Change from BL at FU | 4.3 U/L | Standard Deviation 1.5 |
| Group I Placebo + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Alkaline Phosphatase. SAD Group | Change from BL at 24h | 2.0 U/L | Standard Deviation 2.8 |
| Group I Placebo + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Alkaline Phosphatase. SAD Group | Baseline (pre-dose Day 1) | 54.5 U/L | Standard Deviation 2.1 |
| Group I Placebo + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Alkaline Phosphatase. SAD Group | Change from BL at FU | 2.0 U/L | Standard Deviation 2.8 |
| Group I 100mg + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Alkaline Phosphatase. SAD Group | Baseline (pre-dose Day 1) | 62.3 U/L | Standard Deviation 21.7 |
| Group I 100mg + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Alkaline Phosphatase. SAD Group | Change from BL at FU | -0.8 U/L | Standard Deviation 4.9 |
| Group I 100mg + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Alkaline Phosphatase. SAD Group | Change from BL at 24h | 0.8 U/L | Standard Deviation 3.6 |
Primary
Change From Baseline in Chemistry Laboratory Test Results by Time Point: Aspartate Aminotransferase. MAD Group
Blood samples were collected from participants at the indicated timepoints for evaluation of chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time frame: Baseline, Day 3, Day 8, FU (one week after last dosing)
Population: The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Aspartate Aminotransferase. MAD Group | Baseline (pre-dose Day 1) | 20.3 U/L | Standard Deviation 3.8 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Aspartate Aminotransferase. MAD Group | Change from BL at Day 3 | -2.0 U/L | Standard Deviation 4.2 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Aspartate Aminotransferase. MAD Group | Change from BL at Day 8 | -1.0 U/L | Standard Deviation 6.1 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Aspartate Aminotransferase. MAD Group | Change from BL at FU | 1.5 U/L | Standard Deviation 3.9 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Aspartate Aminotransferase. MAD Group | Change from BL at Day 3 | -5.0 U/L | Standard Deviation 1.4 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Aspartate Aminotransferase. MAD Group | Change from BL at Day 8 | -2.8 U/L | Standard Deviation 1.9 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Aspartate Aminotransferase. MAD Group | Change from BL at FU | 1.3 U/L | Standard Deviation 4.6 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Aspartate Aminotransferase. MAD Group | Baseline (pre-dose Day 1) | 21.5 U/L | Standard Deviation 5.7 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Aspartate Aminotransferase. MAD Group | Change from BL at Day 8 | -0.3 U/L | Standard Deviation 2.8 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Aspartate Aminotransferase. MAD Group | Change from BL at Day 3 | -2.5 U/L | Standard Deviation 1.3 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Aspartate Aminotransferase. MAD Group | Change from BL at FU | 9.8 U/L | Standard Deviation 16.3 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Aspartate Aminotransferase. MAD Group | Baseline (pre-dose Day 1) | 18.5 U/L | Standard Deviation 0.6 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Aspartate Aminotransferase. MAD Group | Change from BL at FU | 2.8 U/L | Standard Deviation 8.2 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Aspartate Aminotransferase. MAD Group | Change from BL at Day 3 | -1.7 U/L | Standard Deviation 3.6 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Aspartate Aminotransferase. MAD Group | Baseline (pre-dose Day 1) | 23.0 U/L | Standard Deviation 6.6 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Aspartate Aminotransferase. MAD Group | Change from BL at Day 8 | -1.5 U/L | Standard Deviation 4.8 |
Primary
Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Aspartate Aminotransferase. SAD Group
Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time frame: Baseline (pre-dose Day 1), 24h post dose, FU (7 days post dose)
Population: The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Aspartate Aminotransferase. SAD Group | Change from BL at FU | 0.3 U/L | Standard Deviation 1 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Aspartate Aminotransferase. SAD Group | Change from BL at 24h | -2.7 U/L | Standard Deviation 1.2 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Aspartate Aminotransferase. SAD Group | Baseline (pre-dose Day 1) | 20.5 U/L | Standard Deviation 5.9 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Aspartate Aminotransferase. SAD Group | Change from BL at 24h | 0.3 U/L | Standard Deviation 2.1 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Aspartate Aminotransferase. SAD Group | Change from BL at FU | 3.3 U/L | Standard Deviation 5.8 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Aspartate Aminotransferase. SAD Group | Baseline (pre-dose Day 1) | 16.8 U/L | Standard Deviation 2.7 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Aspartate Aminotransferase. SAD Group | Change from BL at 24h | -0.5 U/L | Standard Deviation 1.3 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Aspartate Aminotransferase. SAD Group | Baseline (pre-dose Day 1) | 19.3 U/L | Standard Deviation 4.3 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Aspartate Aminotransferase. SAD Group | Change from BL at FU | 2.8 U/L | Standard Deviation 6.2 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Aspartate Aminotransferase. SAD Group | Baseline (pre-dose Day 1) | 17.5 U/L | Standard Deviation 3.8 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Aspartate Aminotransferase. SAD Group | Change from BL at FU | 4.8 U/L | Standard Deviation 7.6 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Aspartate Aminotransferase. SAD Group | Change from BL at 24h | 1.8 U/L | Standard Deviation 3 |
| SAD Group I 100mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Aspartate Aminotransferase. SAD Group | Change from BL at FU | 0.3 U/L | Standard Deviation 4.9 |
| SAD Group I 100mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Aspartate Aminotransferase. SAD Group | Change from BL at 24h | -2.5 U/L | Standard Deviation 4.7 |
| SAD Group I 100mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Aspartate Aminotransferase. SAD Group | Baseline (pre-dose Day 1) | 18.3 U/L | Standard Deviation 9.2 |
| SAD Group II 300mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Aspartate Aminotransferase. SAD Group | Change from BL at FU | 0.5 U/L | Standard Deviation 7.6 |
| SAD Group II 300mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Aspartate Aminotransferase. SAD Group | Baseline (pre-dose Day 1) | 20.8 U/L | Standard Deviation 4.4 |
| SAD Group II 300mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Aspartate Aminotransferase. SAD Group | Change from BL at 24h | -0.3 U/L | Standard Deviation 1 |
| SAD Group I 800mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Aspartate Aminotransferase. SAD Group | Change from BL at FU | 1.3 U/L | Standard Deviation 3.6 |
| SAD Group I 800mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Aspartate Aminotransferase. SAD Group | Change from BL at 24h | -1.0 U/L | Standard Deviation 3.3 |
| SAD Group I 800mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Aspartate Aminotransferase. SAD Group | Baseline (pre-dose Day 1) | 18.8 U/L | Standard Deviation 6.1 |
| SAD Group II 2000mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Aspartate Aminotransferase. SAD Group | Change from BL at FU | 1.0 U/L | Standard Deviation 3.7 |
| SAD Group II 2000mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Aspartate Aminotransferase. SAD Group | Change from BL at 24h | 0.5 U/L | Standard Deviation 2.5 |
| SAD Group II 2000mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Aspartate Aminotransferase. SAD Group | Baseline (pre-dose Day 1) | 17.0 U/L | Standard Deviation 2.9 |
| Group I Placebo + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Aspartate Aminotransferase. SAD Group | Baseline (pre-dose Day 1) | 19.5 U/L | Standard Deviation 2.1 |
| Group I Placebo + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Aspartate Aminotransferase. SAD Group | Change from BL at FU | 3.5 U/L | Standard Deviation 6.4 |
| Group I Placebo + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Aspartate Aminotransferase. SAD Group | Change from BL at 24h | -1.0 U/L | Standard Deviation 2.8 |
| Group I 100mg + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Aspartate Aminotransferase. SAD Group | Change from BL at FU | 0.0 U/L | Standard Deviation 1.4 |
| Group I 100mg + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Aspartate Aminotransferase. SAD Group | Change from BL at 24h | -1.0 U/L | Standard Deviation 2.2 |
| Group I 100mg + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Aspartate Aminotransferase. SAD Group | Baseline (pre-dose Day 1) | 18.5 U/L | Standard Deviation 4.8 |
Primary
Change From Baseline in Chemistry Laboratory Test Results by Time Point: Bicarbonate. MAD Group
Blood samples were collected from participants at the indicated timepoints for evaluation of chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time frame: Baseline, Day 3, Day 8, FU (one week after last dosing)
Population: The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Bicarbonate. MAD Group | Baseline (pre-dose Day 1) | 27.53 mmol/L | Standard Deviation 0.54 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Bicarbonate. MAD Group | Change from BL at Day 3 | -0.38 mmol/L | Standard Deviation 0.79 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Bicarbonate. MAD Group | Change from BL at Day 8 | -1.10 mmol/L | Standard Deviation 1.62 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Bicarbonate. MAD Group | Change from BL at FU | -1.18 mmol/L | Standard Deviation 0.69 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Bicarbonate. MAD Group | Change from BL at Day 3 | 2.20 mmol/L | Standard Deviation 1.51 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Bicarbonate. MAD Group | Change from BL at Day 8 | 1.42 mmol/L | Standard Deviation 1.59 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Bicarbonate. MAD Group | Change from BL at FU | 1.68 mmol/L | Standard Deviation 1.27 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Bicarbonate. MAD Group | Baseline (pre-dose Day 1) | 25.53 mmol/L | Standard Deviation 0.92 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Bicarbonate. MAD Group | Change from BL at Day 8 | -0.55 mmol/L | Standard Deviation 1.72 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Bicarbonate. MAD Group | Change from BL at Day 3 | 0.10 mmol/L | Standard Deviation 1.55 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Bicarbonate. MAD Group | Change from BL at FU | -0.32 mmol/L | Standard Deviation 1.78 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Bicarbonate. MAD Group | Baseline (pre-dose Day 1) | 28.53 mmol/L | Standard Deviation 0.59 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Bicarbonate. MAD Group | Change from BL at FU | -0.27 mmol/L | Standard Deviation 1.87 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Bicarbonate. MAD Group | Change from BL at Day 3 | 0.03 mmol/L | Standard Deviation 1.4 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Bicarbonate. MAD Group | Baseline (pre-dose Day 1) | 27.23 mmol/L | Standard Deviation 0.87 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Bicarbonate. MAD Group | Change from BL at Day 8 | 0.47 mmol/L | Standard Deviation 1.69 |
Primary
Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Bicarbonate. SAD Group
Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time frame: Baseline (pre-dose Day 1), 24h post dose, FU (7 days post dose)
Population: The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Bicarbonate. SAD Group | Baseline (pre-dose Day 1) | 25.68 mmol/L | Standard Deviation 1.38 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Bicarbonate. SAD Group | Change from BL at FU | -1.22 mmol/L | Standard Deviation 1.38 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Bicarbonate. SAD Group | Change from BL at 24h | -0.05 mmol/L | Standard Deviation 1.15 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Bicarbonate. SAD Group | Change from BL at 24h | 0.28 mmol/L | Standard Deviation 1.31 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Bicarbonate. SAD Group | Change from BL at FU | 0.97 mmol/L | Standard Deviation 1.04 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Bicarbonate. SAD Group | Baseline (pre-dose Day 1) | 25.22 mmol/L | Standard Deviation 0.51 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Bicarbonate. SAD Group | Change from BL at FU | -0.58 mmol/L | Standard Deviation 1.46 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Bicarbonate. SAD Group | Baseline (pre-dose Day 1) | 24.78 mmol/L | Standard Deviation 1.09 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Bicarbonate. SAD Group | Change from BL at 24h | 1.05 mmol/L | Standard Deviation 1.27 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Bicarbonate. SAD Group | Change from BL at FU | 0.95 mmol/L | Standard Deviation 0.88 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Bicarbonate. SAD Group | Baseline (pre-dose Day 1) | 25.85 mmol/L | Standard Deviation 0.53 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Bicarbonate. SAD Group | Change from BL at 24h | 1.18 mmol/L | Standard Deviation 0.9 |
| SAD Group I 100mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Bicarbonate. SAD Group | Baseline (pre-dose Day 1) | 24.85 mmol/L | Standard Deviation 1.21 |
| SAD Group I 100mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Bicarbonate. SAD Group | Change from BL at 24h | 0.40 mmol/L | Standard Deviation 0.94 |
| SAD Group I 100mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Bicarbonate. SAD Group | Change from BL at FU | -0.15 mmol/L | Standard Deviation 0.55 |
| SAD Group II 300mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Bicarbonate. SAD Group | Change from BL at 24h | 2.35 mmol/L | Standard Deviation 0.7 |
| SAD Group II 300mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Bicarbonate. SAD Group | Baseline (pre-dose Day 1) | 24.28 mmol/L | Standard Deviation 0.33 |
| SAD Group II 300mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Bicarbonate. SAD Group | Change from BL at FU | 1.65 mmol/L | Standard Deviation 1.2 |
| SAD Group I 800mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Bicarbonate. SAD Group | Baseline (pre-dose Day 1) | 27.05 mmol/L | Standard Deviation 0.91 |
| SAD Group I 800mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Bicarbonate. SAD Group | Change from BL at FU | -2.38 mmol/L | Standard Deviation 1.64 |
| SAD Group I 800mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Bicarbonate. SAD Group | Change from BL at 24h | -0.17 mmol/L | Standard Deviation 0.94 |
| SAD Group II 2000mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Bicarbonate. SAD Group | Change from BL at 24h | 0.05 mmol/L | Standard Deviation 1.55 |
| SAD Group II 2000mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Bicarbonate. SAD Group | Baseline (pre-dose Day 1) | 26.03 mmol/L | Standard Deviation 1.8 |
| SAD Group II 2000mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Bicarbonate. SAD Group | Change from BL at FU | -0.20 mmol/L | Standard Deviation 1.03 |
| Group I Placebo + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Bicarbonate. SAD Group | Change from BL at 24h | 1.95 mmol/L | Standard Deviation 0.64 |
| Group I Placebo + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Bicarbonate. SAD Group | Baseline (pre-dose Day 1) | 24.90 mmol/L | Standard Deviation 0.71 |
| Group I Placebo + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Bicarbonate. SAD Group | Change from BL at FU | -0.55 mmol/L | Standard Deviation 0.49 |
| Group I 100mg + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Bicarbonate. SAD Group | Baseline (pre-dose Day 1) | 25.93 mmol/L | Standard Deviation 0.84 |
| Group I 100mg + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Bicarbonate. SAD Group | Change from BL at FU | -1.23 mmol/L | Standard Deviation 0.3 |
| Group I 100mg + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Bicarbonate. SAD Group | Change from BL at 24h | 0.05 mmol/L | Standard Deviation 0.39 |
Primary
Change From Baseline in Chemistry Laboratory Test Results by Time Point: Calcium (Corrected for Albumin). MAD Group
Blood samples were collected from participants at the indicated timepoints for evaluation of chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time frame: Baseline, Day 3, Day 8, FU (one week after last dosing)
Population: The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Calcium (Corrected for Albumin). MAD Group | Baseline (pre-dose Day 1) | 2.278 mmol/L | Standard Deviation 0.117 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Calcium (Corrected for Albumin). MAD Group | Change from BL at Day 3 | 0.105 mmol/L | Standard Deviation 0.051 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Calcium (Corrected for Albumin). MAD Group | Change from BL at Day 8 | 0.127 mmol/L | Standard Deviation 0.091 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Calcium (Corrected for Albumin). MAD Group | Change from BL at FU | 0.087 mmol/L | Standard Deviation 0.088 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Calcium (Corrected for Albumin). MAD Group | Change from BL at Day 3 | 0.083 mmol/L | Standard Deviation 0.067 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Calcium (Corrected for Albumin). MAD Group | Change from BL at Day 8 | 0.083 mmol/L | Standard Deviation 0.063 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Calcium (Corrected for Albumin). MAD Group | Change from BL at FU | 0.083 mmol/L | Standard Deviation 0.075 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Calcium (Corrected for Albumin). MAD Group | Baseline (pre-dose Day 1) | 2.310 mmol/L | Standard Deviation 0.058 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Calcium (Corrected for Albumin). MAD Group | Change from BL at Day 8 | 0.100 mmol/L | Standard Deviation 0.095 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Calcium (Corrected for Albumin). MAD Group | Change from BL at Day 3 | 0.048 mmol/L | Standard Deviation 0.068 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Calcium (Corrected for Albumin). MAD Group | Change from BL at FU | 0.045 mmol/L | Standard Deviation 0.082 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Calcium (Corrected for Albumin). MAD Group | Baseline (pre-dose Day 1) | 2.265 mmol/L | Standard Deviation 0.024 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Calcium (Corrected for Albumin). MAD Group | Change from BL at FU | 0.055 mmol/L | Standard Deviation 0.037 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Calcium (Corrected for Albumin). MAD Group | Change from BL at Day 3 | 0.068 mmol/L | Standard Deviation 0.046 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Calcium (Corrected for Albumin). MAD Group | Baseline (pre-dose Day 1) | 2.323 mmol/L | Standard Deviation 0.039 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Calcium (Corrected for Albumin). MAD Group | Change from BL at Day 8 | 0.088 mmol/L | Standard Deviation 0.037 |
Primary
Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Calcium (Corrected for Albumin). SAD Group
Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time frame: Baseline (pre-dose Day 1), 24h post dose, FU (7 days post dose)
Population: The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Calcium (Corrected for Albumin). SAD Group | Baseline (pre-dose Day 1) | 2.380 mmol/L | Standard Deviation 0.073 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Calcium (Corrected for Albumin). SAD Group | Change from BL at FU | 0.010 mmol/L | Standard Deviation 0.041 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Calcium (Corrected for Albumin). SAD Group | Change from BL at 24h | 0.033 mmol/L | Standard Deviation 0.045 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Calcium (Corrected for Albumin). SAD Group | Change from BL at 24h | 0.095 mmol/L | Standard Deviation 0.066 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Calcium (Corrected for Albumin). SAD Group | Change from BL at FU | 0.062 mmol/L | Standard Deviation 0.075 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Calcium (Corrected for Albumin). SAD Group | Baseline (pre-dose Day 1) | 2.303 mmol/L | Standard Deviation 0.087 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Calcium (Corrected for Albumin). SAD Group | Change from BL at FU | 0.085 mmol/L | Standard Deviation 0.07 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Calcium (Corrected for Albumin). SAD Group | Baseline (pre-dose Day 1) | 2.290 mmol/L | Standard Deviation 0.114 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Calcium (Corrected for Albumin). SAD Group | Change from BL at 24h | 0.098 mmol/L | Standard Deviation 0.05 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Calcium (Corrected for Albumin). SAD Group | Change from BL at FU | 0.073 mmol/L | Standard Deviation 0.098 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Calcium (Corrected for Albumin). SAD Group | Baseline (pre-dose Day 1) | 2.288 mmol/L | Standard Deviation 0.03 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Calcium (Corrected for Albumin). SAD Group | Change from BL at 24h | 0.093 mmol/L | Standard Deviation 0.028 |
| SAD Group I 100mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Calcium (Corrected for Albumin). SAD Group | Baseline (pre-dose Day 1) | 2.373 mmol/L | Standard Deviation 0.116 |
| SAD Group I 100mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Calcium (Corrected for Albumin). SAD Group | Change from BL at 24h | 0.058 mmol/L | Standard Deviation 0.105 |
| SAD Group I 100mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Calcium (Corrected for Albumin). SAD Group | Change from BL at FU | 0.042 mmol/L | Standard Deviation 0.03 |
| SAD Group II 300mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Calcium (Corrected for Albumin). SAD Group | Change from BL at 24h | 0.085 mmol/L | Standard Deviation 0.059 |
| SAD Group II 300mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Calcium (Corrected for Albumin). SAD Group | Baseline (pre-dose Day 1) | 2.358 mmol/L | Standard Deviation 0.069 |
| SAD Group II 300mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Calcium (Corrected for Albumin). SAD Group | Change from BL at FU | -0.032 mmol/L | Standard Deviation 0.006 |
| SAD Group I 800mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Calcium (Corrected for Albumin). SAD Group | Baseline (pre-dose Day 1) | 2.353 mmol/L | Standard Deviation 0.102 |
| SAD Group I 800mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Calcium (Corrected for Albumin). SAD Group | Change from BL at FU | -0.005 mmol/L | Standard Deviation 0.033 |
| SAD Group I 800mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Calcium (Corrected for Albumin). SAD Group | Change from BL at 24h | 0.078 mmol/L | Standard Deviation 0.075 |
| SAD Group II 2000mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Calcium (Corrected for Albumin). SAD Group | Change from BL at 24h | 0.148 mmol/L | Standard Deviation 0.055 |
| SAD Group II 2000mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Calcium (Corrected for Albumin). SAD Group | Baseline (pre-dose Day 1) | 2.323 mmol/L | Standard Deviation 0.044 |
| SAD Group II 2000mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Calcium (Corrected for Albumin). SAD Group | Change from BL at FU | 0.090 mmol/L | Standard Deviation 0.059 |
| Group I Placebo + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Calcium (Corrected for Albumin). SAD Group | Change from BL at 24h | -0.005 mmol/L | Standard Deviation 0.021 |
| Group I Placebo + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Calcium (Corrected for Albumin). SAD Group | Baseline (pre-dose Day 1) | 2.340 mmol/L | Standard Deviation 0 |
| Group I Placebo + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Calcium (Corrected for Albumin). SAD Group | Change from BL at FU | -0.065 mmol/L | Standard Deviation 0.049 |
| Group I 100mg + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Calcium (Corrected for Albumin). SAD Group | Baseline (pre-dose Day 1) | 2.360 mmol/L | Standard Deviation 0.118 |
| Group I 100mg + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Calcium (Corrected for Albumin). SAD Group | Change from BL at FU | 0.055 mmol/L | Standard Deviation 0.039 |
| Group I 100mg + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Calcium (Corrected for Albumin). SAD Group | Change from BL at 24h | 0.075 mmol/L | Standard Deviation 0.088 |
Primary
Change From Baseline in Chemistry Laboratory Test Results by Time Point: Chloride. MAD Group
Blood samples were collected from participants at the indicated timepoints for evaluation of chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time frame: Baseline, Day 3, Day 8, FU (one week after last dosing)
Population: The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Chloride. MAD Group | Baseline (pre-dose Day 1) | 103.8 mmol/L | Standard Deviation 2.2 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Chloride. MAD Group | Change from BL at Day 3 | -2.5 mmol/L | Standard Deviation 0.6 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Chloride. MAD Group | Change from BL at Day 8 | -3.5 mmol/L | Standard Deviation 1 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Chloride. MAD Group | Change from BL at FU | -2.0 mmol/L | Standard Deviation 0 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Chloride. MAD Group | Change from BL at Day 3 | -2.0 mmol/L | Standard Deviation 1.8 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Chloride. MAD Group | Change from BL at Day 8 | -2.0 mmol/L | Standard Deviation 1.4 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Chloride. MAD Group | Change from BL at FU | -2.3 mmol/L | Standard Deviation 1.9 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Chloride. MAD Group | Baseline (pre-dose Day 1) | 101.5 mmol/L | Standard Deviation 0.6 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Chloride. MAD Group | Change from BL at Day 8 | -2.8 mmol/L | Standard Deviation 1 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Chloride. MAD Group | Change from BL at Day 3 | -1.5 mmol/L | Standard Deviation 0.6 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Chloride. MAD Group | Change from BL at FU | -2.0 mmol/L | Standard Deviation 0.8 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Chloride. MAD Group | Baseline (pre-dose Day 1) | 102.0 mmol/L | Standard Deviation 1.8 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Chloride. MAD Group | Change from BL at FU | -1.3 mmol/L | Standard Deviation 1.5 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Chloride. MAD Group | Change from BL at Day 3 | -1.5 mmol/L | Standard Deviation 0.8 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Chloride. MAD Group | Baseline (pre-dose Day 1) | 102.2 mmol/L | Standard Deviation 1.5 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Chloride. MAD Group | Change from BL at Day 8 | -2.2 mmol/L | Standard Deviation 2.1 |
Primary
Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Chloride. SAD Group
Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time frame: Baseline (pre-dose Day 1), 24h post dose, FU (7 days post dose)
Population: The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Chloride. SAD Group | Baseline (pre-dose Day 1) | 102.7 mmol/L | Standard Deviation 2.7 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Chloride. SAD Group | Change from BL at FU | -1.5 mmol/L | Standard Deviation 3.5 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Chloride. SAD Group | Change from BL at 24h | -0.5 mmol/L | Standard Deviation 1.4 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Chloride. SAD Group | Change from BL at 24h | -2.5 mmol/L | Standard Deviation 1.4 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Chloride. SAD Group | Change from BL at FU | -3.2 mmol/L | Standard Deviation 2.2 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Chloride. SAD Group | Baseline (pre-dose Day 1) | 104.0 mmol/L | Standard Deviation 1.7 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Chloride. SAD Group | Change from BL at FU | -2.5 mmol/L | Standard Deviation 2.1 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Chloride. SAD Group | Baseline (pre-dose Day 1) | 103.8 mmol/L | Standard Deviation 1.7 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Chloride. SAD Group | Change from BL at 24h | -1.5 mmol/L | Standard Deviation 2.5 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Chloride. SAD Group | Change from BL at FU | -3.5 mmol/L | Standard Deviation 1.3 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Chloride. SAD Group | Baseline (pre-dose Day 1) | 104.0 mmol/L | Standard Deviation 0.8 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Chloride. SAD Group | Change from BL at 24h | -3.5 mmol/L | Standard Deviation 0.6 |
| SAD Group I 100mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Chloride. SAD Group | Baseline (pre-dose Day 1) | 102.3 mmol/L | Standard Deviation 2.4 |
| SAD Group I 100mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Chloride. SAD Group | Change from BL at 24h | 0.0 mmol/L | Standard Deviation 1.8 |
| SAD Group I 100mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Chloride. SAD Group | Change from BL at FU | -0.8 mmol/L | Standard Deviation 2.2 |
| SAD Group II 300mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Chloride. SAD Group | Change from BL at 24h | -2.8 mmol/L | Standard Deviation 1 |
| SAD Group II 300mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Chloride. SAD Group | Baseline (pre-dose Day 1) | 103.0 mmol/L | Standard Deviation 1.4 |
| SAD Group II 300mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Chloride. SAD Group | Change from BL at FU | -2.3 mmol/L | Standard Deviation 2.2 |
| SAD Group I 800mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Chloride. SAD Group | Baseline (pre-dose Day 1) | 103.3 mmol/L | Standard Deviation 1.5 |
| SAD Group I 800mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Chloride. SAD Group | Change from BL at FU | -0.8 mmol/L | Standard Deviation 3.5 |
| SAD Group I 800mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Chloride. SAD Group | Change from BL at 24h | -1.3 mmol/L | Standard Deviation 1 |
| SAD Group II 2000mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Chloride. SAD Group | Change from BL at 24h | -3.5 mmol/L | Standard Deviation 1.7 |
| SAD Group II 2000mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Chloride. SAD Group | Baseline (pre-dose Day 1) | 103.8 mmol/L | Standard Deviation 1.7 |
| SAD Group II 2000mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Chloride. SAD Group | Change from BL at FU | -3.0 mmol/L | Standard Deviation 0 |
| Group I Placebo + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Chloride. SAD Group | Change from BL at 24h | 2.0 mmol/L | Standard Deviation 0 |
| Group I Placebo + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Chloride. SAD Group | Baseline (pre-dose Day 1) | 100.5 mmol/L | Standard Deviation 2.1 |
| Group I Placebo + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Chloride. SAD Group | Change from BL at FU | 3.5 mmol/L | Standard Deviation 3.5 |
| Group I 100mg + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Chloride. SAD Group | Baseline (pre-dose Day 1) | 101.5 mmol/L | Standard Deviation 2.1 |
| Group I 100mg + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Chloride. SAD Group | Change from BL at FU | 0.0 mmol/L | Standard Deviation 2.7 |
| Group I 100mg + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Chloride. SAD Group | Change from BL at 24h | -0.5 mmol/L | Standard Deviation 1.3 |
Primary
Change From Baseline in Chemistry Laboratory Test Results by Time Point: Cholesterol. MAD Group
Blood samples were collected from participants at the indicated timepoints for evaluation of chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time frame: Baseline, Day 3, Day 8, FU (one week after last dosing)
Population: The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Cholesterol. MAD Group | Baseline (pre-dose Day 1) | 192.8 mg/dL | Standard Deviation 33.5 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Cholesterol. MAD Group | Change from BL at Day 3 | 20.0 mg/dL | Standard Deviation 11.5 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Cholesterol. MAD Group | Change from BL at Day 8 | 32.3 mg/dL | Standard Deviation 25.3 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Cholesterol. MAD Group | Change from BL at FU | 9.3 mg/dL | Standard Deviation 14.2 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Cholesterol. MAD Group | Change from BL at Day 3 | 8.8 mg/dL | Standard Deviation 9.7 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Cholesterol. MAD Group | Change from BL at Day 8 | 2.5 mg/dL | Standard Deviation 20.5 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Cholesterol. MAD Group | Change from BL at FU | 8.0 mg/dL | Standard Deviation 22.2 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Cholesterol. MAD Group | Baseline (pre-dose Day 1) | 191.0 mg/dL | Standard Deviation 11.3 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Cholesterol. MAD Group | Change from BL at Day 8 | 13.3 mg/dL | Standard Deviation 17.7 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Cholesterol. MAD Group | Change from BL at Day 3 | 13.5 mg/dL | Standard Deviation 4 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Cholesterol. MAD Group | Change from BL at FU | 9.8 mg/dL | Standard Deviation 17.8 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Cholesterol. MAD Group | Baseline (pre-dose Day 1) | 203.5 mg/dL | Standard Deviation 7.4 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Cholesterol. MAD Group | Change from BL at FU | -5.5 mg/dL | Standard Deviation 8.6 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Cholesterol. MAD Group | Change from BL at Day 3 | 19.7 mg/dL | Standard Deviation 15.3 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Cholesterol. MAD Group | Baseline (pre-dose Day 1) | 177.8 mg/dL | Standard Deviation 30.7 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Cholesterol. MAD Group | Change from BL at Day 8 | 24.3 mg/dL | Standard Deviation 24.4 |
Primary
Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Cholesterol. SAD Group
Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time frame: Baseline (pre-dose Day 1), 24h post dose, FU (7 days post dose)
Population: The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Cholesterol. SAD Group | Baseline (pre-dose Day 1) | 176.0 mg/dL | Standard Deviation 47.7 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Cholesterol. SAD Group | Change from BL at FU | 5.0 mg/dL | Standard Deviation 20.4 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Cholesterol. SAD Group | Change from BL at 24h | 4.8 mg/dL | Standard Deviation 5.5 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Cholesterol. SAD Group | Change from BL at 24h | 12.5 mg/dL | Standard Deviation 10.6 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Cholesterol. SAD Group | Change from BL at FU | 26.3 mg/dL | Standard Deviation 27.2 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Cholesterol. SAD Group | Baseline (pre-dose Day 1) | 151.0 mg/dL | Standard Deviation 26.6 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Cholesterol. SAD Group | Change from BL at FU | 25.3 mg/dL | Standard Deviation 5.1 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Cholesterol. SAD Group | Baseline (pre-dose Day 1) | 146.3 mg/dL | Standard Deviation 37.5 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Cholesterol. SAD Group | Change from BL at 24h | 5.3 mg/dL | Standard Deviation 2.2 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Cholesterol. SAD Group | Change from BL at FU | 21.5 mg/dL | Standard Deviation 15.5 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Cholesterol. SAD Group | Baseline (pre-dose Day 1) | 149.0 mg/dL | Standard Deviation 38.3 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Cholesterol. SAD Group | Change from BL at 24h | 5.3 mg/dL | Standard Deviation 6.4 |
| SAD Group I 100mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Cholesterol. SAD Group | Baseline (pre-dose Day 1) | 146.5 mg/dL | Standard Deviation 49.7 |
| SAD Group I 100mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Cholesterol. SAD Group | Change from BL at 24h | 9.5 mg/dL | Standard Deviation 14 |
| SAD Group I 100mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Cholesterol. SAD Group | Change from BL at FU | 28.3 mg/dL | Standard Deviation 17.7 |
| SAD Group II 300mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Cholesterol. SAD Group | Change from BL at 24h | 19.5 mg/dL | Standard Deviation 4 |
| SAD Group II 300mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Cholesterol. SAD Group | Baseline (pre-dose Day 1) | 167.5 mg/dL | Standard Deviation 42.3 |
| SAD Group II 300mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Cholesterol. SAD Group | Change from BL at FU | 24.3 mg/dL | Standard Deviation 16.7 |
| SAD Group I 800mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Cholesterol. SAD Group | Baseline (pre-dose Day 1) | 212.8 mg/dL | Standard Deviation 48.2 |
| SAD Group I 800mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Cholesterol. SAD Group | Change from BL at FU | -13.8 mg/dL | Standard Deviation 33.7 |
| SAD Group I 800mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Cholesterol. SAD Group | Change from BL at 24h | 8.3 mg/dL | Standard Deviation 21 |
| SAD Group II 2000mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Cholesterol. SAD Group | Change from BL at 24h | 25.0 mg/dL | Standard Deviation 12.7 |
| SAD Group II 2000mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Cholesterol. SAD Group | Baseline (pre-dose Day 1) | 174.5 mg/dL | Standard Deviation 34.5 |
| SAD Group II 2000mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Cholesterol. SAD Group | Change from BL at FU | 6.8 mg/dL | Standard Deviation 5.4 |
| Group I Placebo + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Cholesterol. SAD Group | Change from BL at 24h | 12.5 mg/dL | Standard Deviation 12 |
| Group I Placebo + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Cholesterol. SAD Group | Baseline (pre-dose Day 1) | 200.5 mg/dL | Standard Deviation 10.6 |
| Group I Placebo + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Cholesterol. SAD Group | Change from BL at FU | -2.5 mg/dL | Standard Deviation 41.7 |
| Group I 100mg + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Cholesterol. SAD Group | Baseline (pre-dose Day 1) | 166.5 mg/dL | Standard Deviation 28.1 |
| Group I 100mg + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Cholesterol. SAD Group | Change from BL at FU | 8.3 mg/dL | Standard Deviation 9.3 |
| Group I 100mg + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Cholesterol. SAD Group | Change from BL at 24h | 5.8 mg/dL | Standard Deviation 10.7 |
Primary
Change From Baseline in Chemistry Laboratory Test Results by Time Point: Creatine Kinase. MAD Group
Blood samples were collected from participants at the indicated timepoints for evaluation of chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time frame: Baseline, Day 3, Day 8, FU (one week after last dosing)
Population: The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Creatine Kinase. MAD Group | Baseline (pre-dose Day 1) | 129.5 U/L | Standard Deviation 62 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Creatine Kinase. MAD Group | Change from BL at Day 3 | -48.5 U/L | Standard Deviation 40.7 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Creatine Kinase. MAD Group | Change from BL at Day 8 | -50.8 U/L | Standard Deviation 49.4 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Creatine Kinase. MAD Group | Change from BL at FU | 27.0 U/L | Standard Deviation 23.1 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Creatine Kinase. MAD Group | Change from BL at Day 3 | -68.8 U/L | Standard Deviation 57.3 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Creatine Kinase. MAD Group | Change from BL at Day 8 | -83.8 U/L | Standard Deviation 91.7 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Creatine Kinase. MAD Group | Change from BL at FU | -7.5 U/L | Standard Deviation 81.2 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Creatine Kinase. MAD Group | Baseline (pre-dose Day 1) | 192.3 U/L | Standard Deviation 149.4 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Creatine Kinase. MAD Group | Change from BL at Day 8 | -68.0 U/L | Standard Deviation 57.7 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Creatine Kinase. MAD Group | Change from BL at Day 3 | -58.0 U/L | Standard Deviation 53.3 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Creatine Kinase. MAD Group | Change from BL at FU | 150.5 U/L | Standard Deviation 313.3 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Creatine Kinase. MAD Group | Baseline (pre-dose Day 1) | 146.5 U/L | Standard Deviation 70.8 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Creatine Kinase. MAD Group | Change from BL at FU | 42.2 U/L | Standard Deviation 153.5 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Creatine Kinase. MAD Group | Change from BL at Day 3 | -106.5 U/L | Standard Deviation 115.2 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Creatine Kinase. MAD Group | Baseline (pre-dose Day 1) | 229.8 U/L | Standard Deviation 156 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Creatine Kinase. MAD Group | Change from BL at Day 8 | -123.5 U/L | Standard Deviation 144.9 |
Primary
Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Creatinine Kinase. SAD Group
Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time frame: Baseline (pre-dose Day 1), 24h post dose, FU (7 days post dose)
Population: The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Creatinine Kinase. SAD Group | Baseline (pre-dose Day 1) | 118.2 U/L | Standard Deviation 39.3 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Creatinine Kinase. SAD Group | Change from BL at FU | 13.0 U/L | Standard Deviation 43.7 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Creatinine Kinase. SAD Group | Change from BL at 24h | -34.3 U/L | Standard Deviation 23.1 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Creatinine Kinase. SAD Group | Change from BL at 24h | -14.0 U/L | Standard Deviation 3.3 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Creatinine Kinase. SAD Group | Change from BL at FU | 16.7 U/L | Standard Deviation 35.7 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Creatinine Kinase. SAD Group | Baseline (pre-dose Day 1) | 78.7 U/L | Standard Deviation 5.9 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Creatinine Kinase. SAD Group | Change from BL at FU | -17.3 U/L | Standard Deviation 88.6 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Creatinine Kinase. SAD Group | Baseline (pre-dose Day 1) | 181.8 U/L | Standard Deviation 59.3 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Creatinine Kinase. SAD Group | Change from BL at 24h | -51.0 U/L | Standard Deviation 34.6 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Creatinine Kinase. SAD Group | Change from BL at FU | 24.5 U/L | Standard Deviation 39.4 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Creatinine Kinase. SAD Group | Baseline (pre-dose Day 1) | 78.8 U/L | Standard Deviation 13.4 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Creatinine Kinase. SAD Group | Change from BL at 24h | -12.8 U/L | Standard Deviation 1.9 |
| SAD Group I 100mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Creatinine Kinase. SAD Group | Baseline (pre-dose Day 1) | 209.3 U/L | Standard Deviation 223.6 |
| SAD Group I 100mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Creatinine Kinase. SAD Group | Change from BL at 24h | -97.8 U/L | Standard Deviation 137.1 |
| SAD Group I 100mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Creatinine Kinase. SAD Group | Change from BL at FU | -110.0 U/L | Standard Deviation 173.1 |
| SAD Group II 300mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Creatinine Kinase. SAD Group | Change from BL at 24h | -15.5 U/L | Standard Deviation 14.1 |
| SAD Group II 300mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Creatinine Kinase. SAD Group | Baseline (pre-dose Day 1) | 82.3 U/L | Standard Deviation 28 |
| SAD Group II 300mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Creatinine Kinase. SAD Group | Change from BL at FU | 6.0 U/L | Standard Deviation 7.5 |
| SAD Group I 800mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Creatinine Kinase. SAD Group | Baseline (pre-dose Day 1) | 68.5 U/L | Standard Deviation 49.5 |
| SAD Group I 800mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Creatinine Kinase. SAD Group | Change from BL at FU | 15.8 U/L | Standard Deviation 16.9 |
| SAD Group I 800mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Creatinine Kinase. SAD Group | Change from BL at 24h | -14.0 U/L | Standard Deviation 23.6 |
| SAD Group II 2000mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Creatinine Kinase. SAD Group | Change from BL at 24h | -14.8 U/L | Standard Deviation 26.9 |
| SAD Group II 2000mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Creatinine Kinase. SAD Group | Baseline (pre-dose Day 1) | 89.5 U/L | Standard Deviation 45.4 |
| SAD Group II 2000mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Creatinine Kinase. SAD Group | Change from BL at FU | 7.0 U/L | Standard Deviation 61.9 |
| Group I Placebo + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Creatinine Kinase. SAD Group | Change from BL at 24h | -31.5 U/L | Standard Deviation 43.1 |
| Group I Placebo + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Creatinine Kinase. SAD Group | Baseline (pre-dose Day 1) | 82.5 U/L | Standard Deviation 89.8 |
| Group I Placebo + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Creatinine Kinase. SAD Group | Change from BL at FU | 21.5 U/L | Standard Deviation 17.7 |
| Group I 100mg + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Creatinine Kinase. SAD Group | Baseline (pre-dose Day 1) | 81.3 U/L | Standard Deviation 29.4 |
| Group I 100mg + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Creatinine Kinase. SAD Group | Change from BL at FU | 18.0 U/L | Standard Deviation 31.2 |
| Group I 100mg + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Creatinine Kinase. SAD Group | Change from BL at 24h | -14.8 U/L | Standard Deviation 8.3 |
Primary
Change From Baseline in Chemistry Laboratory Test Results by Time Point: Creatinine. MAD Group
Blood samples were collected from participants at the indicated timepoints for evaluation of chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time frame: Baseline, Day 3, Day 8, FU (one week after last dosing)
Population: The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Creatinine. MAD Group | Change from BL at Day 3 | 0.095 mg/dL | Standard Deviation 0.025 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Creatinine. MAD Group | Baseline (pre-dose Day 1) | 0.910 mg/dL | Standard Deviation 0.042 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Creatinine. MAD Group | Change from BL at Day 8 | 0.005 mg/dL | Standard Deviation 0.247 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Creatinine. MAD Group | Change from BL at FU | 0.008 mg/dL | Standard Deviation 0.13 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Creatinine. MAD Group | Change from BL at Day 3 | 0.122 mg/dL | Standard Deviation 0.033 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Creatinine. MAD Group | Change from BL at Day 8 | 0.122 mg/dL | Standard Deviation 0.069 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Creatinine. MAD Group | Baseline (pre-dose Day 1) | 0.960 mg/dL | Standard Deviation 0.079 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Creatinine. MAD Group | Change from BL at FU | -0.020 mg/dL | Standard Deviation 0.024 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Creatinine. MAD Group | Baseline (pre-dose Day 1) | 0.913 mg/dL | Standard Deviation 0.067 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Creatinine. MAD Group | Change from BL at Day 3 | 0.165 mg/dL | Standard Deviation 0.031 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Creatinine. MAD Group | Change from BL at FU | 0.017 mg/dL | Standard Deviation 0.043 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Creatinine. MAD Group | Change from BL at Day 8 | 0.133 mg/dL | Standard Deviation 0.082 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Creatinine. MAD Group | Change from BL at FU | 0.007 mg/dL | Standard Deviation 0.039 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Creatinine. MAD Group | Change from BL at Day 8 | 0.053 mg/dL | Standard Deviation 0.056 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Creatinine. MAD Group | Change from BL at Day 3 | 0.057 mg/dL | Standard Deviation 0.05 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Creatinine. MAD Group | Baseline (pre-dose Day 1) | 0.897 mg/dL | Standard Deviation 0.11 |
Primary
Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Creatinine. SAD Group
Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time frame: Baseline (pre-dose Day 1), 24h post dose, FU (7 days post dose)
Population: The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Creatinine. SAD Group | Baseline (pre-dose Day 1) | 0.927 mg/dL | Standard Deviation 0.058 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Creatinine. SAD Group | Change from BL at FU | -0.003 mg/dL | Standard Deviation 0.048 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Creatinine. SAD Group | Change from BL at 24h | 0.023 mg/dL | Standard Deviation 0.05 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Creatinine. SAD Group | Change from BL at 24h | 0.067 mg/dL | Standard Deviation 0.033 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Creatinine. SAD Group | Change from BL at FU | 0.065 mg/dL | Standard Deviation 0.048 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Creatinine. SAD Group | Baseline (pre-dose Day 1) | 0.768 mg/dL | Standard Deviation 0.108 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Creatinine. SAD Group | Change from BL at FU | 0.012 mg/dL | Standard Deviation 0.039 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Creatinine. SAD Group | Baseline (pre-dose Day 1) | 0.903 mg/dL | Standard Deviation 0.028 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Creatinine. SAD Group | Change from BL at 24h | 0.080 mg/dL | Standard Deviation 0.054 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Creatinine. SAD Group | Change from BL at FU | 0.073 mg/dL | Standard Deviation 0.056 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Creatinine. SAD Group | Baseline (pre-dose Day 1) | 0.810 mg/dL | Standard Deviation 0.091 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Creatinine. SAD Group | Change from BL at 24h | 0.053 mg/dL | Standard Deviation 0.076 |
| SAD Group I 100mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Creatinine. SAD Group | Baseline (pre-dose Day 1) | 0.838 mg/dL | Standard Deviation 0.035 |
| SAD Group I 100mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Creatinine. SAD Group | Change from BL at 24h | 0.040 mg/dL | Standard Deviation 0.041 |
| SAD Group I 100mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Creatinine. SAD Group | Change from BL at FU | 0.088 mg/dL | Standard Deviation 0.068 |
| SAD Group II 300mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Creatinine. SAD Group | Change from BL at 24h | 0.115 mg/dL | Standard Deviation 0.025 |
| SAD Group II 300mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Creatinine. SAD Group | Baseline (pre-dose Day 1) | 0.735 mg/dL | Standard Deviation 0.108 |
| SAD Group II 300mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Creatinine. SAD Group | Change from BL at FU | 0.063 mg/dL | Standard Deviation 0.028 |
| SAD Group I 800mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Creatinine. SAD Group | Baseline (pre-dose Day 1) | 0.918 mg/dL | Standard Deviation 0.043 |
| SAD Group I 800mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Creatinine. SAD Group | Change from BL at FU | -0.020 mg/dL | Standard Deviation 0.096 |
| SAD Group I 800mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Creatinine. SAD Group | Change from BL at 24h | 0.090 mg/dL | Standard Deviation 0.043 |
| SAD Group II 2000mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Creatinine. SAD Group | Change from BL at 24h | 0.075 mg/dL | Standard Deviation 0.112 |
| SAD Group II 2000mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Creatinine. SAD Group | Baseline (pre-dose Day 1) | 0.838 mg/dL | Standard Deviation 0.213 |
| SAD Group II 2000mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Creatinine. SAD Group | Change from BL at FU | -0.017 mg/dL | Standard Deviation 0.085 |
| Group I Placebo + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Creatinine. SAD Group | Change from BL at 24h | 0.015 mg/dL | Standard Deviation 0.106 |
| Group I Placebo + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Creatinine. SAD Group | Baseline (pre-dose Day 1) | 0.935 mg/dL | Standard Deviation 0.078 |
| Group I Placebo + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Creatinine. SAD Group | Change from BL at FU | -0.080 mg/dL | Standard Deviation 0.071 |
| Group I 100mg + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Creatinine. SAD Group | Baseline (pre-dose Day 1) | 0.863 mg/dL | Standard Deviation 0.024 |
| Group I 100mg + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Creatinine. SAD Group | Change from BL at FU | 0.063 mg/dL | Standard Deviation 0.068 |
| Group I 100mg + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Creatinine. SAD Group | Change from BL at 24h | 0.038 mg/dL | Standard Deviation 0.071 |
Primary
Change From Baseline in Chemistry Laboratory Test Results by Time Point: Fasting Glucose. MAD Group
Blood samples were collected from participants at the indicated timepoints for evaluation of chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time frame: Baseline, Day 3, Day 8, FU (one week after last dosing)
Population: The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Fasting Glucose. MAD Group | Baseline (pre-dose Day 1) | 89.0 mg/dL | Standard Deviation 5.4 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Fasting Glucose. MAD Group | Change from BL at Day 3 | -6.8 mg/dL | Standard Deviation 4.5 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Fasting Glucose. MAD Group | Change from BL at Day 8 | -6.5 mg/dL | Standard Deviation 7 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Fasting Glucose. MAD Group | Change from BL at FU | -2.2 mg/dL | Standard Deviation 1.4 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Fasting Glucose. MAD Group | Change from BL at Day 3 | 2.8 mg/dL | Standard Deviation 6.3 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Fasting Glucose. MAD Group | Change from BL at Day 8 | -9.5 mg/dL | Standard Deviation 5.5 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Fasting Glucose. MAD Group | Change from BL at FU | 2.0 mg/dL | Standard Deviation 5.7 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Fasting Glucose. MAD Group | Baseline (pre-dose Day 1) | 85.5 mg/dL | Standard Deviation 13.8 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Fasting Glucose. MAD Group | Change from BL at Day 8 | -7.0 mg/dL | Standard Deviation 6.1 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Fasting Glucose. MAD Group | Change from BL at Day 3 | -6.8 mg/dL | Standard Deviation 7.9 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Fasting Glucose. MAD Group | Change from BL at FU | -10.8 mg/dL | Standard Deviation 7.8 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Fasting Glucose. MAD Group | Baseline (pre-dose Day 1) | 89.8 mg/dL | Standard Deviation 7.5 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Fasting Glucose. MAD Group | Change from BL at FU | 0.0 mg/dL | Standard Deviation 7.2 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Fasting Glucose. MAD Group | Change from BL at Day 3 | 1.5 mg/dL | Standard Deviation 2.5 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Fasting Glucose. MAD Group | Baseline (pre-dose Day 1) | 87.2 mg/dL | Standard Deviation 10 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Fasting Glucose. MAD Group | Change from BL at Day 8 | -3.5 mg/dL | Standard Deviation 7.7 |
Primary
Change From Baseline in Chemistry Laboratory Test Results by Timepoint: (Fasting) Glucose. SAD Group
Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time frame: Baseline (pre-dose Day 1), 24h post dose, FU (7 days post dose)
Population: The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: (Fasting) Glucose. SAD Group | Change from BL at 24h | -1.0 mg/dL | Standard Deviation 3.2 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: (Fasting) Glucose. SAD Group | Baseline (pre-dose Day 1) | 85.0 mg/dL | Standard Deviation 7.3 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: (Fasting) Glucose. SAD Group | Change from BL at FU | -0.2 mg/dL | Standard Deviation 7 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: (Fasting) Glucose. SAD Group | Change from BL at FU | 5.5 mg/dL | Standard Deviation 6.9 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: (Fasting) Glucose. SAD Group | Change from BL at 24h | 1.2 mg/dL | Standard Deviation 5.2 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: (Fasting) Glucose. SAD Group | Baseline (pre-dose Day 1) | 86.8 mg/dL | Standard Deviation 8.9 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: (Fasting) Glucose. SAD Group | Baseline (pre-dose Day 1) | 84.8 mg/dL | Standard Deviation 7.4 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: (Fasting) Glucose. SAD Group | Change from BL at FU | -0.3 mg/dL | Standard Deviation 7.7 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: (Fasting) Glucose. SAD Group | Change from BL at 24h | 2.0 mg/dL | Standard Deviation 3.7 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: (Fasting) Glucose. SAD Group | Change from BL at 24h | -2.0 mg/dL | Standard Deviation 3.2 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: (Fasting) Glucose. SAD Group | Baseline (pre-dose Day 1) | 88.5 mg/dL | Standard Deviation 12.2 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: (Fasting) Glucose. SAD Group | Change from BL at FU | 6.3 mg/dL | Standard Deviation 6.7 |
| SAD Group I 100mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: (Fasting) Glucose. SAD Group | Change from BL at FU | 7.3 mg/dL | Standard Deviation 6.2 |
| SAD Group I 100mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: (Fasting) Glucose. SAD Group | Baseline (pre-dose Day 1) | 77.8 mg/dL | Standard Deviation 5.7 |
| SAD Group I 100mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: (Fasting) Glucose. SAD Group | Change from BL at 24h | 7.0 mg/dL | Standard Deviation 4.5 |
| SAD Group II 300mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: (Fasting) Glucose. SAD Group | Change from BL at FU | 0.5 mg/dL | Standard Deviation 5.9 |
| SAD Group II 300mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: (Fasting) Glucose. SAD Group | Baseline (pre-dose Day 1) | 86.3 mg/dL | Standard Deviation 9.4 |
| SAD Group II 300mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: (Fasting) Glucose. SAD Group | Change from BL at 24h | -1.0 mg/dL | Standard Deviation 1.4 |
| SAD Group I 800mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: (Fasting) Glucose. SAD Group | Change from BL at 24h | 0.5 mg/dL | Standard Deviation 3.1 |
| SAD Group I 800mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: (Fasting) Glucose. SAD Group | Change from BL at FU | -1.3 mg/dL | Standard Deviation 5.4 |
| SAD Group I 800mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: (Fasting) Glucose. SAD Group | Baseline (pre-dose Day 1) | 87.0 mg/dL | Standard Deviation 4.2 |
| SAD Group II 2000mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: (Fasting) Glucose. SAD Group | Change from BL at 24h | -2.3 mg/dL | Standard Deviation 1 |
| SAD Group II 2000mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: (Fasting) Glucose. SAD Group | Baseline (pre-dose Day 1) | 95.5 mg/dL | Standard Deviation 18.7 |
| SAD Group II 2000mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: (Fasting) Glucose. SAD Group | Change from BL at FU | -1.5 mg/dL | Standard Deviation 1.7 |
| Group I Placebo + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: (Fasting) Glucose. SAD Group | Change from BL at FU | 2.0 mg/dL | Standard Deviation 8.5 |
| Group I Placebo + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: (Fasting) Glucose. SAD Group | Change from BL at 24h | 4.0 mg/dL | Standard Deviation 1.4 |
| Group I Placebo + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: (Fasting) Glucose. SAD Group | Baseline (pre-dose Day 1) | 84.0 mg/dL | Standard Deviation 5.7 |
| Group I 100mg + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: (Fasting) Glucose. SAD Group | Change from BL at 24h | 3.3 mg/dL | Standard Deviation 1.9 |
| Group I 100mg + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: (Fasting) Glucose. SAD Group | Change from BL at FU | 6.3 mg/dL | Standard Deviation 3.8 |
| Group I 100mg + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: (Fasting) Glucose. SAD Group | Baseline (pre-dose Day 1) | 78.8 mg/dL | Standard Deviation 3.8 |
Primary
Change From Baseline in Chemistry Laboratory Test Results by Time Point: Gamma GT. MAD Group
Blood samples were collected from participants at the indicated timepoints for evaluation of chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time frame: Baseline, Day 3, Day 8, FU (one week after last dosing)
Population: The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Gamma GT. MAD Group | Baseline (pre-dose Day 1) | 15.5 U/L | Standard Deviation 7 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Gamma GT. MAD Group | Change from BL at Day 3 | 0.5 U/L | Standard Deviation 1 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Gamma GT. MAD Group | Change from BL at Day 8 | 0.8 U/L | Standard Deviation 1.9 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Gamma GT. MAD Group | Change from BL at FU | 1.3 U/L | Standard Deviation 1.3 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Gamma GT. MAD Group | Change from BL at Day 3 | 0.3 U/L | Standard Deviation 1.3 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Gamma GT. MAD Group | Change from BL at Day 8 | 0.3 U/L | Standard Deviation 3 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Gamma GT. MAD Group | Change from BL at FU | -0.5 U/L | Standard Deviation 3.1 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Gamma GT. MAD Group | Baseline (pre-dose Day 1) | 18.3 U/L | Standard Deviation 9.2 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Gamma GT. MAD Group | Change from BL at Day 8 | 1.8 U/L | Standard Deviation 2.8 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Gamma GT. MAD Group | Change from BL at Day 3 | 2.0 U/L | Standard Deviation 2.2 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Gamma GT. MAD Group | Change from BL at FU | 1.8 U/L | Standard Deviation 2.2 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Gamma GT. MAD Group | Baseline (pre-dose Day 1) | 20.5 U/L | Standard Deviation 14.5 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Gamma GT. MAD Group | Change from BL at FU | -0.8 U/L | Standard Deviation 2.5 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Gamma GT. MAD Group | Change from BL at Day 3 | 0.7 U/L | Standard Deviation 1.2 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Gamma GT. MAD Group | Baseline (pre-dose Day 1) | 21.5 U/L | Standard Deviation 11.3 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Gamma GT. MAD Group | Change from BL at Day 8 | 0.0 U/L | Standard Deviation 2.2 |
Primary
Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Gamma-GT. SAD Group
Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value
Time frame: Baseline (pre-dose Day 1), 24h post dose, FU (7 days post dose)
Population: The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Gamma-GT. SAD Group | Baseline (pre-dose Day 1) | 23.5 U/L | Standard Deviation 26.7 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Gamma-GT. SAD Group | Change from BL at FU | -4.0 U/L | Standard Deviation 13.8 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Gamma-GT. SAD Group | Change from BL at 24h | -0.8 U/L | Standard Deviation 1.7 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Gamma-GT. SAD Group | Change from BL at FU | 10.0 U/L | Standard Deviation 16.1 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Gamma-GT. SAD Group | Change from BL at 24h | 1.2 U/L | Standard Deviation 2.1 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Gamma-GT. SAD Group | Baseline (pre-dose Day 1) | 19.0 U/L | Standard Deviation 14.1 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Gamma-GT. SAD Group | Change from BL at FU | -1.3 U/L | Standard Deviation 4.5 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Gamma-GT. SAD Group | Baseline (pre-dose Day 1) | 24.0 U/L | Standard Deviation 20 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Gamma-GT. SAD Group | Change from BL at 24h | 0.0 U/L | Standard Deviation 0.8 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Gamma-GT. SAD Group | Change from BL at 24h | 0.8 U/L | Standard Deviation 1.7 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Gamma-GT. SAD Group | Change from BL at FU | 13.8 U/L | Standard Deviation 18.4 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Gamma-GT. SAD Group | Baseline (pre-dose Day 1) | 23.0 U/L | Standard Deviation 16.2 |
| SAD Group I 100mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Gamma-GT. SAD Group | Change from BL at FU | 2.5 U/L | Standard Deviation 2.4 |
| SAD Group I 100mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Gamma-GT. SAD Group | Baseline (pre-dose Day 1) | 12.0 U/L | Standard Deviation 6.8 |
| SAD Group I 100mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Gamma-GT. SAD Group | Change from BL at 24h | 0.3 U/L | Standard Deviation 1.3 |
| SAD Group II 300mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Gamma-GT. SAD Group | Change from BL at 24h | 1.3 U/L | Standard Deviation 0.5 |
| SAD Group II 300mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Gamma-GT. SAD Group | Baseline (pre-dose Day 1) | 17.3 U/L | Standard Deviation 12.1 |
| SAD Group II 300mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Gamma-GT. SAD Group | Change from BL at FU | 11.3 U/L | Standard Deviation 20.5 |
| SAD Group I 800mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Gamma-GT. SAD Group | Change from BL at 24h | -0.5 U/L | Standard Deviation 4.4 |
| SAD Group I 800mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Gamma-GT. SAD Group | Change from BL at FU | -7.3 U/L | Standard Deviation 15.6 |
| SAD Group I 800mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Gamma-GT. SAD Group | Baseline (pre-dose Day 1) | 30.0 U/L | Standard Deviation 30.8 |
| SAD Group II 2000mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Gamma-GT. SAD Group | Change from BL at FU | 1.8 U/L | Standard Deviation 2.5 |
| SAD Group II 2000mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Gamma-GT. SAD Group | Change from BL at 24h | 3.8 U/L | Standard Deviation 3.1 |
| SAD Group II 2000mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Gamma-GT. SAD Group | Baseline (pre-dose Day 1) | 21.3 U/L | Standard Deviation 17.2 |
| Group I Placebo + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Gamma-GT. SAD Group | Change from BL at 24h | 0.0 U/L | Standard Deviation 2.8 |
| Group I Placebo + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Gamma-GT. SAD Group | Baseline (pre-dose Day 1) | 29.0 U/L | Standard Deviation 14.1 |
| Group I Placebo + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Gamma-GT. SAD Group | Change from BL at FU | 3.5 U/L | Standard Deviation 3.5 |
| Group I 100mg + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Gamma-GT. SAD Group | Baseline (pre-dose Day 1) | 13.5 U/L | Standard Deviation 5.1 |
| Group I 100mg + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Gamma-GT. SAD Group | Change from BL at FU | 1.0 U/L | Standard Deviation 0.8 |
| Group I 100mg + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Gamma-GT. SAD Group | Change from BL at 24h | 0.8 U/L | Standard Deviation 1 |
Primary
Change From Baseline in Chemistry Laboratory Test Results by Time Point: High Density Lipoproteins. MAD Group
Blood samples were collected from participants at the indicated timepoints for evaluation of chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time frame: Baseline, Day 3, Day 8, FU (one week after last dosing)
Population: The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: High Density Lipoproteins. MAD Group | Baseline (pre-dose Day 1) | 51.0 mg/dL | Standard Deviation 15.1 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: High Density Lipoproteins. MAD Group | Change from BL at Day 3 | -1.0 mg/dL | Standard Deviation 5.7 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: High Density Lipoproteins. MAD Group | Change from BL at Day 8 | -5.0 mg/dL | Standard Deviation 6.1 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: High Density Lipoproteins. MAD Group | Change from BL at FU | -2.5 mg/dL | Standard Deviation 2.1 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: High Density Lipoproteins. MAD Group | Change from BL at Day 3 | -3.0 mg/dL | Standard Deviation 4.8 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: High Density Lipoproteins. MAD Group | Change from BL at Day 8 | -7.8 mg/dL | Standard Deviation 8.6 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: High Density Lipoproteins. MAD Group | Change from BL at FU | 1.3 mg/dL | Standard Deviation 9.9 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: High Density Lipoproteins. MAD Group | Baseline (pre-dose Day 1) | 61.0 mg/dL | Standard Deviation 20.1 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: High Density Lipoproteins. MAD Group | Change from BL at Day 8 | -3.5 mg/dL | Standard Deviation 11.2 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: High Density Lipoproteins. MAD Group | Change from BL at Day 3 | -1.5 mg/dL | Standard Deviation 5.8 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: High Density Lipoproteins. MAD Group | Change from BL at FU | 7.5 mg/dL | Standard Deviation 12.1 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: High Density Lipoproteins. MAD Group | Baseline (pre-dose Day 1) | 53.5 mg/dL | Standard Deviation 20.5 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: High Density Lipoproteins. MAD Group | Change from BL at FU | -2.2 mg/dL | Standard Deviation 8.9 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: High Density Lipoproteins. MAD Group | Change from BL at Day 3 | -2.5 mg/dL | Standard Deviation 6.2 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: High Density Lipoproteins. MAD Group | Baseline (pre-dose Day 1) | 66.8 mg/dL | Standard Deviation 17.7 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: High Density Lipoproteins. MAD Group | Change from BL at Day 8 | -7.0 mg/dL | Standard Deviation 6.6 |
Primary
Change From Baseline in Chemistry Laboratory Test Results by Timepoint: High Density Lipoproteins. SAD Group
Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time frame: Baseline (pre-dose Day 1), 24h post dose, FU (7 days post dose)
Population: The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: High Density Lipoproteins. SAD Group | Change from BL at 24h | -2.8 mg/dL | Standard Deviation 2.4 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: High Density Lipoproteins. SAD Group | Baseline (pre-dose Day 1) | 50.0 mg/dL | Standard Deviation 11.1 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: High Density Lipoproteins. SAD Group | Change from BL at FU | 1.8 mg/dL | Standard Deviation 5.2 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: High Density Lipoproteins. SAD Group | Change from BL at FU | 4.5 mg/dL | Standard Deviation 5 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: High Density Lipoproteins. SAD Group | Baseline (pre-dose Day 1) | 49.8 mg/dL | Standard Deviation 8.4 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: High Density Lipoproteins. SAD Group | Change from BL at 24h | 0.5 mg/dL | Standard Deviation 3.1 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: High Density Lipoproteins. SAD Group | Change from BL at FU | 6.3 mg/dL | Standard Deviation 4.6 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: High Density Lipoproteins. SAD Group | Baseline (pre-dose Day 1) | 45.5 mg/dL | Standard Deviation 11 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: High Density Lipoproteins. SAD Group | Change from BL at 24h | 1.0 mg/dL | Standard Deviation 1.2 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: High Density Lipoproteins. SAD Group | Change from BL at FU | 3.0 mg/dL | Standard Deviation 3.6 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: High Density Lipoproteins. SAD Group | Baseline (pre-dose Day 1) | 49.5 mg/dL | Standard Deviation 8.9 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: High Density Lipoproteins. SAD Group | Change from BL at 24h | -2.5 mg/dL | Standard Deviation 2.9 |
| SAD Group I 100mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: High Density Lipoproteins. SAD Group | Baseline (pre-dose Day 1) | 40.0 mg/dL | Standard Deviation 4.1 |
| SAD Group I 100mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: High Density Lipoproteins. SAD Group | Change from BL at FU | 7.3 mg/dL | Standard Deviation 2.6 |
| SAD Group I 100mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: High Density Lipoproteins. SAD Group | Change from BL at 24h | -1.3 mg/dL | Standard Deviation 2.1 |
| SAD Group II 300mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: High Density Lipoproteins. SAD Group | Change from BL at 24h | 2.8 mg/dL | Standard Deviation 2.2 |
| SAD Group II 300mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: High Density Lipoproteins. SAD Group | Change from BL at FU | 2.8 mg/dL | Standard Deviation 5.1 |
| SAD Group II 300mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: High Density Lipoproteins. SAD Group | Baseline (pre-dose Day 1) | 54.5 mg/dL | Standard Deviation 5.5 |
| SAD Group I 800mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: High Density Lipoproteins. SAD Group | Change from BL at FU | -3.0 mg/dL | Standard Deviation 9.9 |
| SAD Group I 800mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: High Density Lipoproteins. SAD Group | Baseline (pre-dose Day 1) | 51.5 mg/dL | Standard Deviation 9.6 |
| SAD Group I 800mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: High Density Lipoproteins. SAD Group | Change from BL at 24h | -3.0 mg/dL | Standard Deviation 6 |
| SAD Group II 2000mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: High Density Lipoproteins. SAD Group | Change from BL at 24h | 10.0 mg/dL | Standard Deviation 7.3 |
| SAD Group II 2000mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: High Density Lipoproteins. SAD Group | Baseline (pre-dose Day 1) | 48.0 mg/dL | Standard Deviation 13.3 |
| SAD Group II 2000mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: High Density Lipoproteins. SAD Group | Change from BL at FU | 8.8 mg/dL | Standard Deviation 7.4 |
| Group I Placebo + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: High Density Lipoproteins. SAD Group | Change from BL at 24h | 2.5 mg/dL | Standard Deviation 7.8 |
| Group I Placebo + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: High Density Lipoproteins. SAD Group | Baseline (pre-dose Day 1) | 47.0 mg/dL | Standard Deviation 17 |
| Group I Placebo + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: High Density Lipoproteins. SAD Group | Change from BL at FU | -2.0 mg/dL | Standard Deviation 7.1 |
| Group I 100mg + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: High Density Lipoproteins. SAD Group | Change from BL at FU | 1.5 mg/dL | Standard Deviation 6.1 |
| Group I 100mg + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: High Density Lipoproteins. SAD Group | Baseline (pre-dose Day 1) | 45.8 mg/dL | Standard Deviation 7.3 |
| Group I 100mg + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: High Density Lipoproteins. SAD Group | Change from BL at 24h | -0.3 mg/dL | Standard Deviation 1.5 |
Primary
Change From Baseline in Chemistry Laboratory Test Results by Time Point: Human Serum Albumin. MAD Group
Blood samples were collected from participants at the indicated timepoints for evaluation of chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time frame: Baseline, Day 3, Day 8, FU (one week after last dosing)
Population: The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Human Serum Albumin. MAD Group | Baseline (pre-dose Day 1) | 43.3 g/L | Standard Deviation 2.2 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Human Serum Albumin. MAD Group | Change from BL at Day 3 | 3.3 g/L | Standard Deviation 2.2 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Human Serum Albumin. MAD Group | Change from BL at Day 8 | 5.3 g/L | Standard Deviation 2.6 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Human Serum Albumin. MAD Group | Change from BL at FU | 2.8 g/L | Standard Deviation 2.1 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Human Serum Albumin. MAD Group | Change from BL at Day 3 | 3.8 g/L | Standard Deviation 1.3 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Human Serum Albumin. MAD Group | Change from BL at Day 8 | 3.5 g/L | Standard Deviation 3 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Human Serum Albumin. MAD Group | Change from BL at FU | 3.0 g/L | Standard Deviation 2.4 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Human Serum Albumin. MAD Group | Baseline (pre-dose Day 1) | 45.5 g/L | Standard Deviation 3.1 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Human Serum Albumin. MAD Group | Change from BL at Day 8 | 4.0 g/L | Standard Deviation 1.8 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Human Serum Albumin. MAD Group | Change from BL at Day 3 | 1.3 g/L | Standard Deviation 1 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Human Serum Albumin. MAD Group | Change from BL at FU | 3.3 g/L | Standard Deviation 2.1 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Human Serum Albumin. MAD Group | Baseline (pre-dose Day 1) | 42.8 g/L | Standard Deviation 0.5 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Human Serum Albumin. MAD Group | Change from BL at FU | 1.7 g/L | Standard Deviation 1.4 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Human Serum Albumin. MAD Group | Change from BL at Day 3 | 1.5 g/L | Standard Deviation 2.1 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Human Serum Albumin. MAD Group | Baseline (pre-dose Day 1) | 44.7 g/L | Standard Deviation 1.5 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Human Serum Albumin. MAD Group | Change from BL at Day 8 | 3.8 g/L | Standard Deviation 1.8 |
Primary
Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Human Serum Albumin. SAD Group
Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time frame: Baseline (pre-dose Day 1), 24h post dose, FU (7 days post dose)
Population: The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Human Serum Albumin. SAD Group | Change from BL at FU | 0.2 g/L | Standard Deviation 1.8 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Human Serum Albumin. SAD Group | Baseline (pre-dose Day 1) | 46.2 g/L | Standard Deviation 3.1 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Human Serum Albumin. SAD Group | Change from BL at 24h | -0.3 g/L | Standard Deviation 1.2 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Human Serum Albumin. SAD Group | Change from BL at 24h | 1.7 g/L | Standard Deviation 1.5 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Human Serum Albumin. SAD Group | Baseline (pre-dose Day 1) | 45.0 g/L | Standard Deviation 2.8 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Human Serum Albumin. SAD Group | Change from BL at FU | 2.0 g/L | Standard Deviation 1.4 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Human Serum Albumin. SAD Group | Change from BL at 24h | 0.3 g/L | Standard Deviation 1.5 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Human Serum Albumin. SAD Group | Baseline (pre-dose Day 1) | 45.3 g/L | Standard Deviation 3.9 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Human Serum Albumin. SAD Group | Change from BL at FU | 2.3 g/L | Standard Deviation 1.5 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Human Serum Albumin. SAD Group | Change from BL at FU | 2.0 g/L | Standard Deviation 2.8 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Human Serum Albumin. SAD Group | Baseline (pre-dose Day 1) | 45.0 g/L | Standard Deviation 1.2 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Human Serum Albumin. SAD Group | Change from BL at 24h | 2.0 g/L | Standard Deviation 2.6 |
| SAD Group I 100mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Human Serum Albumin. SAD Group | Change from BL at 24h | 1.5 g/L | Standard Deviation 3.7 |
| SAD Group I 100mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Human Serum Albumin. SAD Group | Baseline (pre-dose Day 1) | 45.3 g/L | Standard Deviation 3.4 |
| SAD Group I 100mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Human Serum Albumin. SAD Group | Change from BL at FU | 1.0 g/L | Standard Deviation 1.2 |
| SAD Group II 300mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Human Serum Albumin. SAD Group | Baseline (pre-dose Day 1) | 46.0 g/L | Standard Deviation 1.4 |
| SAD Group II 300mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Human Serum Albumin. SAD Group | Change from BL at FU | 0.5 g/L | Standard Deviation 1.3 |
| SAD Group II 300mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Human Serum Albumin. SAD Group | Change from BL at 24h | 3.5 g/L | Standard Deviation 1.3 |
| SAD Group I 800mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Human Serum Albumin. SAD Group | Baseline (pre-dose Day 1) | 44.0 g/L | Standard Deviation 1.2 |
| SAD Group I 800mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Human Serum Albumin. SAD Group | Change from BL at FU | 0.0 g/L | Standard Deviation 0.8 |
| SAD Group I 800mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Human Serum Albumin. SAD Group | Change from BL at 24h | 1.5 g/L | Standard Deviation 3.1 |
| SAD Group II 2000mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Human Serum Albumin. SAD Group | Change from BL at FU | 3.5 g/L | Standard Deviation 2.1 |
| SAD Group II 2000mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Human Serum Albumin. SAD Group | Change from BL at 24h | 5.3 g/L | Standard Deviation 2.6 |
| SAD Group II 2000mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Human Serum Albumin. SAD Group | Baseline (pre-dose Day 1) | 44.3 g/L | Standard Deviation 1.5 |
| Group I Placebo + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Human Serum Albumin. SAD Group | Baseline (pre-dose Day 1) | 44.0 g/L | Standard Deviation 1.4 |
| Group I Placebo + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Human Serum Albumin. SAD Group | Change from BL at 24h | 0.5 g/L | Standard Deviation 2.1 |
| Group I Placebo + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Human Serum Albumin. SAD Group | Change from BL at FU | 0.0 g/L | Standard Deviation 0 |
| Group I 100mg + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Human Serum Albumin. SAD Group | Baseline (pre-dose Day 1) | 45.8 g/L | Standard Deviation 3.1 |
| Group I 100mg + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Human Serum Albumin. SAD Group | Change from BL at FU | 05 g/L | Standard Deviation 1.7 |
| Group I 100mg + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Human Serum Albumin. SAD Group | Change from BL at 24h | 0.0 g/L | Standard Deviation 2.7 |
Primary
Change From Baseline in Chemistry Laboratory Test Results by Time Point: Lactate. MAD Group
Blood samples were collected from participants at the indicated timepoints for evaluation of chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time frame: Baseline, Day 3, Day 8, FU (one week after last dosing)
Population: The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Lactate. MAD Group | Change from BL at FU | 2.75 mg/dL | Standard Deviation 3.3 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Lactate. MAD Group | Baseline (pre-dose Day 1) | 8.63 mg/dL | Standard Deviation 4.26 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Lactate. MAD Group | Change from BL at Day 3 | 0.98 mg/dL | Standard Deviation 1.06 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Lactate. MAD Group | Change from BL at Day 8 | 3.13 mg/dL | Standard Deviation 3 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Lactate. MAD Group | Change from BL at Day 8 | 2.30 mg/dL | Standard Deviation 2.08 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Lactate. MAD Group | Change from BL at Day 3 | 2.23 mg/dL | Standard Deviation 4.01 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Lactate. MAD Group | Baseline (pre-dose Day 1) | 7.00 mg/dL | Standard Deviation 1.82 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Lactate. MAD Group | Change from BL at FU | 1.08 mg/dL | Standard Deviation 1.49 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Lactate. MAD Group | Change from BL at Day 3 | 1.18 mg/dL | Standard Deviation 1.41 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Lactate. MAD Group | Change from BL at Day 8 | 1.83 mg/dL | Standard Deviation 1.56 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Lactate. MAD Group | Baseline (pre-dose Day 1) | 7.23 mg/dL | Standard Deviation 1.08 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Lactate. MAD Group | Change from BL at FU | 6.63 mg/dL | Standard Deviation 4.95 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Lactate. MAD Group | Baseline (pre-dose Day 1) | 9.12 mg/dL | Standard Deviation 1.94 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Lactate. MAD Group | Change from BL at FU | -0.12 mg/dL | Standard Deviation 4.07 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Lactate. MAD Group | Change from BL at Day 8 | 1.23 mg/dL | Standard Deviation 3.66 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Lactate. MAD Group | Change from BL at Day 3 | 5.93 mg/dL | Standard Deviation 6.62 |
Primary
Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Lactate. SAD Group
Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time frame: Baseline (pre-dose Day 1), 24h post dose, FU (7 days post dose)
Population: The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Lactate. SAD Group | Baseline (pre-dose Day 1) | 7.98 mg/dL | Standard Deviation 2.47 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Lactate. SAD Group | Change from BL at FU | 1.05 mg/dL | Standard Deviation 4.59 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Lactate. SAD Group | Change from BL at 24h | -0.80 mg/dL | Standard Deviation 1.83 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Lactate. SAD Group | Change from BL at 24h | 1.40 mg/dL | Standard Deviation 2.82 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Lactate. SAD Group | Change from BL at FU | 3.80 mg/dL | Standard Deviation 3.12 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Lactate. SAD Group | Baseline (pre-dose Day 1) | 7.28 mg/dL | Standard Deviation 1.86 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Lactate. SAD Group | Change from BL at FU | 2.25 mg/dL | Standard Deviation 5.84 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Lactate. SAD Group | Baseline (pre-dose Day 1) | 8.65 mg/dL | Standard Deviation 3.2 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Lactate. SAD Group | Change from BL at 24h | -2.08 mg/dL | Standard Deviation 2.41 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Lactate. SAD Group | Change from BL at 24h | 2.10 mg/dL | Standard Deviation 3.81 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Lactate. SAD Group | Baseline (pre-dose Day 1) | 8.23 mg/dL | Standard Deviation 2.04 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Lactate. SAD Group | Change from BL at FU | 3.45 mg/dL | Standard Deviation 3.45 |
| SAD Group I 100mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Lactate. SAD Group | Baseline (pre-dose Day 1) | 8.10 mg/dL | Standard Deviation 2.93 |
| SAD Group I 100mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Lactate. SAD Group | Change from BL at FU | 1.93 mg/dL | Standard Deviation 6.23 |
| SAD Group I 100mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Lactate. SAD Group | Change from BL at 24h | -0.50 mg/dL | Standard Deviation 1.67 |
| SAD Group II 300mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Lactate. SAD Group | Baseline (pre-dose Day 1) | 9.03 mg/dL | Standard Deviation 2.08 |
| SAD Group II 300mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Lactate. SAD Group | Change from BL at 24h | 0.88 mg/dL | Standard Deviation 3.62 |
| SAD Group II 300mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Lactate. SAD Group | Change from BL at FU | 0.70 mg/dL | Standard Deviation 2.45 |
| SAD Group I 800mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Lactate. SAD Group | Change from BL at 24h | 0.78 mg/dL | Standard Deviation 1.75 |
| SAD Group I 800mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Lactate. SAD Group | Baseline (pre-dose Day 1) | 7.53 mg/dL | Standard Deviation 0.97 |
| SAD Group I 800mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Lactate. SAD Group | Change from BL at FU | -0.02 mg/dL | Standard Deviation 3.4 |
| SAD Group II 2000mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Lactate. SAD Group | Change from BL at FU | 4.33 mg/dL | Standard Deviation 3.08 |
| SAD Group II 2000mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Lactate. SAD Group | Baseline (pre-dose Day 1) | 8.58 mg/dL | Standard Deviation 2.68 |
| SAD Group II 2000mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Lactate. SAD Group | Change from BL at 24h | 3.25 mg/dL | Standard Deviation 1.54 |
| Group I Placebo + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Lactate. SAD Group | Change from BL at 24h | -1.05 mg/dL | Standard Deviation 0.07 |
| Group I Placebo + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Lactate. SAD Group | Change from BL at FU | -0.15 mg/dL | Standard Deviation 0.64 |
| Group I Placebo + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Lactate. SAD Group | Baseline (pre-dose Day 1) | 9.85 mg/dL | Standard Deviation 1.34 |
| Group I 100mg + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Lactate. SAD Group | Change from BL at 24h | 0.40 mg/dL | Standard Deviation 2.22 |
| Group I 100mg + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Lactate. SAD Group | Change from BL at FU | 1.70 mg/dL | Standard Deviation 4.59 |
| Group I 100mg + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Lactate. SAD Group | Baseline (pre-dose Day 1) | 8.33 mg/dL | Standard Deviation 1.5 |
Primary
Change From Baseline in Chemistry Laboratory Test Results by Time Point: Lipase. MAD Group
Blood samples were collected from participants at the indicated timepoints for evaluation of chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time frame: Baseline, Day 3, Day 8, FU (one week after last dosing)
Population: The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Lipase. MAD Group | Baseline (pre-dose Day 1) | 26.5 U/L | Standard Deviation 6.1 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Lipase. MAD Group | Change from BL at Day 3 | -1.8 U/L | Standard Deviation 3.1 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Lipase. MAD Group | Change from BL at Day 8 | -0.3 U/L | Standard Deviation 4.1 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Lipase. MAD Group | Change from BL at FU | 3.5 U/L | Standard Deviation 3.3 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Lipase. MAD Group | Change from BL at Day 3 | 0.0 U/L | Standard Deviation 1.8 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Lipase. MAD Group | Change from BL at Day 8 | 1.3 U/L | Standard Deviation 7.4 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Lipase. MAD Group | Change from BL at FU | 17.3 U/L | Standard Deviation 24.4 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Lipase. MAD Group | Baseline (pre-dose Day 1) | 26.5 U/L | Standard Deviation 3.3 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Lipase. MAD Group | Change from BL at Day 8 | 50.5 U/L | Standard Deviation 106.4 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Lipase. MAD Group | Change from BL at Day 3 | 26.0 U/L | Standard Deviation 55.4 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Lipase. MAD Group | Change from BL at FU | -2.8 U/L | Standard Deviation 7.4 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Lipase. MAD Group | Baseline (pre-dose Day 1) | 32.8 U/L | Standard Deviation 12.1 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Lipase. MAD Group | Change from BL at FU | -1.8 U/L | Standard Deviation 7.6 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Lipase. MAD Group | Change from BL at Day 3 | 1.2 U/L | Standard Deviation 4.4 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Lipase. MAD Group | Baseline (pre-dose Day 1) | 34.2 U/L | Standard Deviation 10.3 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Lipase. MAD Group | Change from BL at Day 8 | 1.0 U/L | Standard Deviation 5.1 |
Primary
Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Lipase. SAD Group
Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time frame: Baseline (pre-dose Day 1), 24h post dose, FU (7 days post dose)
Population: The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Lipase. SAD Group | Baseline (pre-dose Day 1) | 31.0 U/L | Standard Deviation 8.2 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Lipase. SAD Group | Change from BL at FU | -1.0 U/L | Standard Deviation 2.3 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Lipase. SAD Group | Change from BL at 24h | -1.5 U/L | Standard Deviation 3.1 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Lipase. SAD Group | Change from BL at 24h | -7.5 U/L | Standard Deviation 18.5 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Lipase. SAD Group | Change from BL at FU | -1.0 U/L | Standard Deviation 5.5 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Lipase. SAD Group | Baseline (pre-dose Day 1) | 34.8 U/L | Standard Deviation 16.2 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Lipase. SAD Group | Change from BL at FU | -4.5 U/L | Standard Deviation 12.4 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Lipase. SAD Group | Baseline (pre-dose Day 1) | 39.0 U/L | Standard Deviation 9.8 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Lipase. SAD Group | Change from BL at 24h | -6.3 U/L | Standard Deviation 6.8 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Lipase. SAD Group | Change from BL at FU | 8.0 U/L | Standard Deviation 27.2 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Lipase. SAD Group | Baseline (pre-dose Day 1) | 29.3 U/L | Standard Deviation 12.7 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Lipase. SAD Group | Change from BL at 24h | -1.8 U/L | Standard Deviation 2.9 |
| SAD Group I 100mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Lipase. SAD Group | Baseline (pre-dose Day 1) | 27.3 U/L | Standard Deviation 7.5 |
| SAD Group I 100mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Lipase. SAD Group | Change from BL at 24h | 1.3 U/L | Standard Deviation 0.5 |
| SAD Group I 100mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Lipase. SAD Group | Change from BL at FU | 1.5 U/L | Standard Deviation 3 |
| SAD Group II 300mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Lipase. SAD Group | Change from BL at 24h | 7.3 U/L | Standard Deviation 16.5 |
| SAD Group II 300mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Lipase. SAD Group | Baseline (pre-dose Day 1) | 33.0 U/L | Standard Deviation 9.2 |
| SAD Group II 300mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Lipase. SAD Group | Change from BL at FU | -5.0 U/L | Standard Deviation 3.7 |
| SAD Group I 800mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Lipase. SAD Group | Baseline (pre-dose Day 1) | 30.0 U/L | Standard Deviation 8 |
| SAD Group I 800mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Lipase. SAD Group | Change from BL at FU | -2.0 U/L | Standard Deviation 6.5 |
| SAD Group I 800mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Lipase. SAD Group | Change from BL at 24h | -1.3 U/L | Standard Deviation 3.4 |
| SAD Group II 2000mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Lipase. SAD Group | Change from BL at 24h | -4.8 U/L | Standard Deviation 5.1 |
| SAD Group II 2000mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Lipase. SAD Group | Baseline (pre-dose Day 1) | 25.5 U/L | Standard Deviation 6.2 |
| SAD Group II 2000mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Lipase. SAD Group | Change from BL at FU | 9.3 U/L | Standard Deviation 19.8 |
| Group I Placebo + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Lipase. SAD Group | Change from BL at 24h | -0.5 U/L | Standard Deviation 2.1 |
| Group I Placebo + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Lipase. SAD Group | Baseline (pre-dose Day 1) | 42.0 U/L | Standard Deviation 14.1 |
| Group I Placebo + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Lipase. SAD Group | Change from BL at FU | -7.0 U/L | Standard Deviation 4.2 |
| Group I 100mg + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Lipase. SAD Group | Baseline (pre-dose Day 1) | 31.1 U/L | Standard Deviation 11.8 |
| Group I 100mg + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Lipase. SAD Group | Change from BL at FU | -2.5 U/L | Standard Deviation 3 |
| Group I 100mg + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Lipase. SAD Group | Change from BL at 24h | -2.5 U/L | Standard Deviation 5.1 |
Primary
Change From Baseline in Chemistry Laboratory Test Results by Time Point: Low Density Lipoproteins. MAD Group
Blood samples were collected from participants at the indicated timepoints for evaluation of chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time frame: Baseline, Day 3, Day 8, FU (one week after last dosing)
Population: The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Low Density Lipoproteins. MAD Group | Baseline (pre-dose Day 1) | 114.1 mg/dL | Standard Deviation 32.7 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Low Density Lipoproteins. MAD Group | Change from BL at Day 3 | 17.9 mg/dL | Standard Deviation 14.5 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Low Density Lipoproteins. MAD Group | Change from BL at Day 8 | 33.2 mg/dL | Standard Deviation 32.8 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Low Density Lipoproteins. MAD Group | Change from BL at FU | 8.1 mg/dL | Standard Deviation 11 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Low Density Lipoproteins. MAD Group | Change from BL at Day 3 | 4.9 mg/dL | Standard Deviation 5.2 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Low Density Lipoproteins. MAD Group | Change from BL at Day 8 | 1.4 mg/dL | Standard Deviation 13.8 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Low Density Lipoproteins. MAD Group | Change from BL at FU | 6.9 mg/dL | Standard Deviation 9.6 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Low Density Lipoproteins. MAD Group | Baseline (pre-dose Day 1) | 112.9 mg/dL | Standard Deviation 19 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Low Density Lipoproteins. MAD Group | Change from BL at Day 8 | 3.5 mg/dL | Standard Deviation 20 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Low Density Lipoproteins. MAD Group | Change from BL at Day 3 | 9.0 mg/dL | Standard Deviation 7.9 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Low Density Lipoproteins. MAD Group | Change from BL at FU | -1.5 mg/dL | Standard Deviation 20.7 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Low Density Lipoproteins. MAD Group | Baseline (pre-dose Day 1) | 127.0 mg/dL | Standard Deviation 18.1 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Low Density Lipoproteins. MAD Group | Change from BL at FU | -1.9 mg/dL | Standard Deviation 9.7 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Low Density Lipoproteins. MAD Group | Change from BL at Day 3 | 18.8 mg/dL | Standard Deviation 13.6 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Low Density Lipoproteins. MAD Group | Baseline (pre-dose Day 1) | 93.3 mg/dL | Standard Deviation 23.7 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Low Density Lipoproteins. MAD Group | Change from BL at Day 8 | 25.6 mg/dL | Standard Deviation 25.7 |
Primary
Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Low Density Lipoproteins. SAD Group
Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time frame: Baseline (pre-dose Day 1), 24h post dose, FU (7 days post dose)
Population: The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Low Density Lipoproteins. SAD Group | Baseline (pre-dose Day 1) | 111.1 mg/dL | Standard Deviation 41.9 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Low Density Lipoproteins. SAD Group | Change from BL at 24h | 4.5 mg/dL | Standard Deviation 6.9 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Low Density Lipoproteins. SAD Group | Change from BL at FU | 0.3 mg/dL | Standard Deviation 19.7 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Low Density Lipoproteins. SAD Group | Change from BL at 24h | 8.3 mg/dL | Standard Deviation 4.6 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Low Density Lipoproteins. SAD Group | Baseline (pre-dose Day 1) | 83.5 mg/dL | Standard Deviation 24.9 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Low Density Lipoproteins. SAD Group | Change from BL at FU | 17.0 mg/dL | Standard Deviation 15.6 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Low Density Lipoproteins. SAD Group | Change from BL at 24h | 2.9 mg/dL | Standard Deviation 3.1 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Low Density Lipoproteins. SAD Group | Change from BL at FU | 13.3 mg/dL | Standard Deviation 10.8 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Low Density Lipoproteins. SAD Group | Baseline (pre-dose Day 1) | 88.9 mg/dL | Standard Deviation 32.5 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Low Density Lipoproteins. SAD Group | Change from BL at FU | 9.6 mg/dL | Standard Deviation 6.9 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Low Density Lipoproteins. SAD Group | Baseline (pre-dose Day 1) | 82.5 mg/dL | Standard Deviation 35.3 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Low Density Lipoproteins. SAD Group | Change from BL at 24h | 1.4 mg/dL | Standard Deviation 6.4 |
| SAD Group I 100mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Low Density Lipoproteins. SAD Group | Baseline (pre-dose Day 1) | 92.3 mg/dL | Standard Deviation 46.4 |
| SAD Group I 100mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Low Density Lipoproteins. SAD Group | Change from BL at 24h | 6.4 mg/dL | Standard Deviation 10.3 |
| SAD Group I 100mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Low Density Lipoproteins. SAD Group | Change from BL at FU | 18.5 mg/dL | Standard Deviation 16.4 |
| SAD Group II 300mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Low Density Lipoproteins. SAD Group | Change from BL at FU | 14.2 mg/dL | Standard Deviation 6.2 |
| SAD Group II 300mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Low Density Lipoproteins. SAD Group | Baseline (pre-dose Day 1) | 98.7 mg/dL | Standard Deviation 35.6 |
| SAD Group II 300mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Low Density Lipoproteins. SAD Group | Change from BL at 24h | 12.8 mg/dL | Standard Deviation 2.6 |
| SAD Group I 800mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Low Density Lipoproteins. SAD Group | Change from BL at FU | -17.9 mg/dL | Standard Deviation 35.8 |
| SAD Group I 800mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Low Density Lipoproteins. SAD Group | Baseline (pre-dose Day 1) | 145.9 mg/dL | Standard Deviation 45.7 |
| SAD Group I 800mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Low Density Lipoproteins. SAD Group | Change from BL at 24h | 5.7 mg/dL | Standard Deviation 16.2 |
| SAD Group II 2000mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Low Density Lipoproteins. SAD Group | Baseline (pre-dose Day 1) | 103.1 mg/dL | Standard Deviation 40 |
| SAD Group II 2000mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Low Density Lipoproteins. SAD Group | Change from BL at FU | 1.3 mg/dL | Standard Deviation 7.7 |
| SAD Group II 2000mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Low Density Lipoproteins. SAD Group | Change from BL at 24h | 16.7 mg/dL | Standard Deviation 7.8 |
| Group I Placebo + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Low Density Lipoproteins. SAD Group | Change from BL at 24h | 10.0 mg/dL | Standard Deviation 9.9 |
| Group I Placebo + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Low Density Lipoproteins. SAD Group | Baseline (pre-dose Day 1) | 134.5 mg/dL | Standard Deviation 16.3 |
| Group I Placebo + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Low Density Lipoproteins. SAD Group | Change from BL at FU | -8.5 mg/dL | Standard Deviation 30.4 |
| Group I 100mg + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Low Density Lipoproteins. SAD Group | Change from BL at 24h | 4.4 mg/dL | Standard Deviation 7.1 |
| Group I 100mg + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Low Density Lipoproteins. SAD Group | Baseline (pre-dose Day 1) | 103.5 mg/dL | Standard Deviation 25.7 |
| Group I 100mg + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Low Density Lipoproteins. SAD Group | Change from BL at FU | 7.2 mg/dL | Standard Deviation 6.8 |
Primary
Change From Baseline in Chemistry Laboratory Test Results by Time Point: Phosphate. MAD Group
Blood samples were collected from participants at the indicated timepoints for evaluation of chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time frame: Baseline, Day 3, Day 8, FU (one week after last dosing)
Population: The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Phosphate. MAD Group | Change from BL at Day 3 | 0.102 mmol/L | Standard Deviation 0.033 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Phosphate. MAD Group | Change from BL at Day 8 | 0.052 mmol/L | Standard Deviation 0.116 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Phosphate. MAD Group | Change from BL at FU | -0.030 mmol/L | Standard Deviation 0.131 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Phosphate. MAD Group | Baseline (pre-dose Day 1) | 0.978 mmol/L | Standard Deviation 0.094 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Phosphate. MAD Group | Baseline (pre-dose Day 1) | 1.033 mmol/L | Standard Deviation 0.164 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Phosphate. MAD Group | Change from BL at FU | -0.010 mmol/L | Standard Deviation 0.034 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Phosphate. MAD Group | Change from BL at Day 8 | 0.000 mmol/L | Standard Deviation 0.085 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Phosphate. MAD Group | Change from BL at Day 3 | 0.003 mmol/L | Standard Deviation 0.074 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Phosphate. MAD Group | Change from BL at FU | 0.053 mmol/L | Standard Deviation 0.189 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Phosphate. MAD Group | Baseline (pre-dose Day 1) | 0.920 mmol/L | Standard Deviation 0.121 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Phosphate. MAD Group | Change from BL at Day 8 | -0.020 mmol/L | Standard Deviation 0.068 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Phosphate. MAD Group | Change from BL at Day 3 | 0.015 mmol/L | Standard Deviation 0.073 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Phosphate. MAD Group | Change from BL at Day 8 | -0.002 mmol/L | Standard Deviation 0.113 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Phosphate. MAD Group | Change from BL at Day 3 | -0.005 mmol/L | Standard Deviation 0.111 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Phosphate. MAD Group | Baseline (pre-dose Day 1) | 1.000 mmol/L | Standard Deviation 0.162 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Phosphate. MAD Group | Change from BL at FU | -0.002 mmol/L | Standard Deviation 0.19 |
Primary
Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Phosphate. SAD Group
Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time frame: Baseline (pre-dose Day 1), 24h post dose, FU (7 days post dose)
Population: The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Phosphate. SAD Group | Change from BL at FU | -0.020 mmol/L | Standard Deviation 0.116 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Phosphate. SAD Group | Baseline (pre-dose Day 1) | 1.042 mmol/L | Standard Deviation 0.066 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Phosphate. SAD Group | Change from BL at 24h | 0.033 mmol/L | Standard Deviation 0.126 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Phosphate. SAD Group | Change from BL at 24h | -0.045 mmol/L | Standard Deviation 0.094 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Phosphate. SAD Group | Baseline (pre-dose Day 1) | 0.998 mmol/L | Standard Deviation 0.122 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Phosphate. SAD Group | Change from BL at FU | 0.030 mmol/L | Standard Deviation 0.172 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Phosphate. SAD Group | Change from BL at 24h | -0.035 mmol/L | Standard Deviation 0.169 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Phosphate. SAD Group | Baseline (pre-dose Day 1) | 1.120 mmol/L | Standard Deviation 0.117 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Phosphate. SAD Group | Change from BL at FU | -0.077 mmol/L | Standard Deviation 0.126 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Phosphate. SAD Group | Change from BL at 24h | -0.133 mmol/L | Standard Deviation 0.105 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Phosphate. SAD Group | Baseline (pre-dose Day 1) | 1.085 mmol/L | Standard Deviation 0.133 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Phosphate. SAD Group | Change from BL at FU | -0.018 mmol/L | Standard Deviation 0.182 |
| SAD Group I 100mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Phosphate. SAD Group | Baseline (pre-dose Day 1) | 1.023 mmol/L | Standard Deviation 0.081 |
| SAD Group I 100mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Phosphate. SAD Group | Change from BL at FU | 0.003 mmol/L | Standard Deviation 0.046 |
| SAD Group I 100mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Phosphate. SAD Group | Change from BL at 24h | 0.045 mmol/L | Standard Deviation 0.172 |
| SAD Group II 300mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Phosphate. SAD Group | Change from BL at FU | -0.070 mmol/L | Standard Deviation 0.153 |
| SAD Group II 300mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Phosphate. SAD Group | Baseline (pre-dose Day 1) | 0.983 mmol/L | Standard Deviation 0.165 |
| SAD Group II 300mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Phosphate. SAD Group | Change from BL at 24h | -0.060 mmol/L | Standard Deviation 0.111 |
| SAD Group I 800mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Phosphate. SAD Group | Change from BL at FU | -0.090 mmol/L | Standard Deviation 0.121 |
| SAD Group I 800mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Phosphate. SAD Group | Change from BL at 24h | 0.032 mmol/L | Standard Deviation 0.116 |
| SAD Group I 800mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Phosphate. SAD Group | Baseline (pre-dose Day 1) | 1.088 mmol/L | Standard Deviation 0.142 |
| SAD Group II 2000mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Phosphate. SAD Group | Baseline (pre-dose Day 1) | 1.128 mmol/L | Standard Deviation 0.193 |
| SAD Group II 2000mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Phosphate. SAD Group | Change from BL at 24h | -0.090 mmol/L | Standard Deviation 0.164 |
| SAD Group II 2000mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Phosphate. SAD Group | Change from BL at FU | -0.105 mmol/L | Standard Deviation 0.135 |
| Group I Placebo + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Phosphate. SAD Group | Change from BL at FU | -0.395 mmol/L | Standard Deviation 0.205 |
| Group I Placebo + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Phosphate. SAD Group | Baseline (pre-dose Day 1) | 1.410 mmol/L | Standard Deviation 0.552 |
| Group I Placebo + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Phosphate. SAD Group | Change from BL at 24h | -0.180 mmol/L | Standard Deviation 0.999 |
| Group I 100mg + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Phosphate. SAD Group | Baseline (pre-dose Day 1) | 1.105 mmol/L | Standard Deviation 0.154 |
| Group I 100mg + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Phosphate. SAD Group | Change from BL at 24h | -0.015 mmol/L | Standard Deviation 0.079 |
| Group I 100mg + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Phosphate. SAD Group | Change from BL at FU | -0.080 mmol/L | Standard Deviation 0.097 |
Primary
Change From Baseline in Chemistry Laboratory Test Results by Time Point: Potassium. MAD Group
Blood samples were collected from participants at the indicated timepoints for evaluation of chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time frame: Baseline, Day 3, Day 8, FU (one week after last dosing)
Population: The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Potassium. MAD Group | Baseline (pre-dose Day 1) | 4.20 mmol/L | Standard Deviation 0.08 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Potassium. MAD Group | Change from BL at Day 3 | 0.45 mmol/L | Standard Deviation 0.19 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Potassium. MAD Group | Change from BL at Day 8 | 0.07 mmol/L | Standard Deviation 0.3 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Potassium. MAD Group | Change from BL at FU | 0.25 mmol/L | Standard Deviation 0.39 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Potassium. MAD Group | Change from BL at Day 3 | 0.33 mmol/L | Standard Deviation 0.37 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Potassium. MAD Group | Change from BL at Day 8 | 0.15 mmol/L | Standard Deviation 0.39 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Potassium. MAD Group | Change from BL at FU | 0.45 mmol/L | Standard Deviation 0.31 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Potassium. MAD Group | Baseline (pre-dose Day 1) | 4.35 mmol/L | Standard Deviation 0.19 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Potassium. MAD Group | Change from BL at Day 8 | 0.25 mmol/L | Standard Deviation 0.42 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Potassium. MAD Group | Change from BL at Day 3 | 0.10 mmol/L | Standard Deviation 0.29 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Potassium. MAD Group | Change from BL at FU | 0.25 mmol/L | Standard Deviation 0.59 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Potassium. MAD Group | Baseline (pre-dose Day 1) | 4.40 mmol/L | Standard Deviation 0.4 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Potassium. MAD Group | Change from BL at FU | 0.30 mmol/L | Standard Deviation 0.26 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Potassium. MAD Group | Change from BL at Day 3 | 0.52 mmol/L | Standard Deviation 0.49 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Potassium. MAD Group | Baseline (pre-dose Day 1) | 4.32 mmol/L | Standard Deviation 0.17 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Potassium. MAD Group | Change from BL at Day 8 | 0.15 mmol/L | Standard Deviation 0.41 |
Primary
Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Potassium. SAD Group
Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time frame: Baseline (pre-dose Day 1), 24h post dose, FU (7 days post dose)
Population: The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Potassium. SAD Group | Change from BL at FU | 0.25 mmol/L | Standard Deviation 0.1 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Potassium. SAD Group | Baseline (pre-dose Day 1) | 4.25 mmol/L | Standard Deviation 0.18 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Potassium. SAD Group | Change from BL at 24h | 0.17 mmol/L | Standard Deviation 0.18 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Potassium. SAD Group | Change from BL at 24h | 0.17 mmol/L | Standard Deviation 0.21 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Potassium. SAD Group | Baseline (pre-dose Day 1) | 4.27 mmol/L | Standard Deviation 0.18 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Potassium. SAD Group | Change from BL at FU | 0.10 mmol/L | Standard Deviation 0.26 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Potassium. SAD Group | Change from BL at 24h | 0.07 mmol/L | Standard Deviation 0.31 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Potassium. SAD Group | Change from BL at FU | 0.30 mmol/L | Standard Deviation 0.22 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Potassium. SAD Group | Baseline (pre-dose Day 1) | 4.25 mmol/L | Standard Deviation 0.13 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Potassium. SAD Group | Change from BL at 24h | 0.23 mmol/L | Standard Deviation 0.33 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Potassium. SAD Group | Change from BL at FU | 0.20 mmol/L | Standard Deviation 0.29 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Potassium. SAD Group | Baseline (pre-dose Day 1) | 4.18 mmol/L | Standard Deviation 0.25 |
| SAD Group I 100mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Potassium. SAD Group | Change from BL at 24h | 0.30 mmol/L | Standard Deviation 0.22 |
| SAD Group I 100mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Potassium. SAD Group | Baseline (pre-dose Day 1) | 4.03 mmol/L | Standard Deviation 0.19 |
| SAD Group I 100mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Potassium. SAD Group | Change from BL at FU | 0.50 mmol/L | Standard Deviation 0.22 |
| SAD Group II 300mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Potassium. SAD Group | Change from BL at 24h | -0.05 mmol/L | Standard Deviation 0.26 |
| SAD Group II 300mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Potassium. SAD Group | Baseline (pre-dose Day 1) | 4.33 mmol/L | Standard Deviation 0.13 |
| SAD Group II 300mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Potassium. SAD Group | Change from BL at FU | 0.10 mmol/L | Standard Deviation 0.27 |
| SAD Group I 800mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Potassium. SAD Group | Baseline (pre-dose Day 1) | 4.28 mmol/L | Standard Deviation 0.32 |
| SAD Group I 800mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Potassium. SAD Group | Change from BL at FU | 0.08 mmol/L | Standard Deviation 0.36 |
| SAD Group I 800mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Potassium. SAD Group | Change from BL at 24h | 0.12 mmol/L | Standard Deviation 0.1 |
| SAD Group II 2000mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Potassium. SAD Group | Change from BL at 24h | -0.10 mmol/L | Standard Deviation 0.16 |
| SAD Group II 2000mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Potassium. SAD Group | Baseline (pre-dose Day 1) | 4.50 mmol/L | Standard Deviation 0.18 |
| SAD Group II 2000mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Potassium. SAD Group | Change from BL at FU | -0.05 mmol/L | Standard Deviation 0.1 |
| Group I Placebo + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Potassium. SAD Group | Change from BL at 24h | 0.25 mmol/L | Standard Deviation 0.07 |
| Group I Placebo + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Potassium. SAD Group | Baseline (pre-dose Day 1) | 4.00 mmol/L | Standard Deviation 0 |
| Group I Placebo + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Potassium. SAD Group | Change from BL at FU | 0.30 mmol/L | Standard Deviation 0.14 |
| Group I 100mg + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Potassium. SAD Group | Baseline (pre-dose Day 1) | 4.20 mmol/L | Standard Deviation 0.22 |
| Group I 100mg + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Potassium. SAD Group | Change from BL at FU | 0.33 mmol/L | Standard Deviation 0.17 |
| Group I 100mg + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Potassium. SAD Group | Change from BL at 24h | 0.15 mmol/L | Standard Deviation 0.34 |
Primary
Change From Baseline in Chemistry Laboratory Test Results by Time Point: Sodium. MAD Group
Blood samples were collected from participants at the indicated timepoints for evaluation of chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time frame: Baseline, Day 3, Day 8, FU (one week after last dosing)
Population: The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Sodium. MAD Group | Baseline (pre-dose Day 1) | 143.8 mmol/L | Standard Deviation 1 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Sodium. MAD Group | Change from BL at Day 3 | -0.5 mmol/L | Standard Deviation 0.6 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Sodium. MAD Group | Change from BL at Day 8 | -3.0 mmol/L | Standard Deviation 0.8 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Sodium. MAD Group | Change from BL at FU | -1.5 mmol/L | Standard Deviation 1 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Sodium. MAD Group | Change from BL at Day 3 | -1.5 mmol/L | Standard Deviation 0.6 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Sodium. MAD Group | Change from BL at Day 8 | 0.8 mmol/L | Standard Deviation 0.5 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Sodium. MAD Group | Change from BL at FU | -0.3 mmol/L | Standard Deviation 2.2 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Sodium. MAD Group | Baseline (pre-dose Day 1) | 141.3 mmol/L | Standard Deviation 0.5 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Sodium. MAD Group | Change from BL at Day 8 | 1.0 mmol/L | Standard Deviation 0.8 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Sodium. MAD Group | Change from BL at Day 3 | 0.8 mmol/L | Standard Deviation 0.5 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Sodium. MAD Group | Change from BL at FU | 2.0 mmol/L | Standard Deviation 2.2 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Sodium. MAD Group | Baseline (pre-dose Day 1) | 141.0 mmol/L | Standard Deviation 1.4 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Sodium. MAD Group | Change from BL at FU | 0.2 mmol/L | Standard Deviation 2.1 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Sodium. MAD Group | Change from BL at Day 3 | -1.0 mmol/L | Standard Deviation 0.6 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Sodium. MAD Group | Baseline (pre-dose Day 1) | 142.0 mmol/L | Standard Deviation 0.9 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Sodium. MAD Group | Change from BL at Day 8 | -0.5 mmol/L | Standard Deviation 1.4 |
Primary
Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Sodium. SAD Group
Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time frame: Baseline (pre-dose Day 1), 24h post dose, FU (7 days post dose)
Population: The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Sodium. SAD Group | Change from BL at FU | -0.3 mmol/L | Standard Deviation 2.4 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Sodium. SAD Group | Baseline (pre-dose Day 1) | 141.8 mmol/L | Standard Deviation 1 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Sodium. SAD Group | Change from BL at 24h | -0.2 mmol/L | Standard Deviation 1.6 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Sodium. SAD Group | Change from BL at FU | -1.8 mmol/L | Standard Deviation 2 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Sodium. SAD Group | Baseline (pre-dose Day 1) | 142.5 mmol/L | Standard Deviation 1.2 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Sodium. SAD Group | Change from BL at 24h | -0.7 mmol/L | Standard Deviation 0.8 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Sodium. SAD Group | Baseline (pre-dose Day 1) | 141.5 mmol/L | Standard Deviation 0.6 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Sodium. SAD Group | Change from BL at FU | 0.0 mmol/L | Standard Deviation 2.7 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Sodium. SAD Group | Change from BL at 24h | -0.3 mmol/L | Standard Deviation 2.2 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Sodium. SAD Group | Change from BL at 24h | -2.0 mmol/L | Standard Deviation 1.4 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Sodium. SAD Group | Baseline (pre-dose Day 1) | 142.8 mmol/L | Standard Deviation 1 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Sodium. SAD Group | Change from BL at FU | -2.3 mmol/L | Standard Deviation 2.2 |
| SAD Group I 100mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Sodium. SAD Group | Change from BL at 24h | -0.8 mmol/L | Standard Deviation 2.2 |
| SAD Group I 100mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Sodium. SAD Group | Baseline (pre-dose Day 1) | 141.5 mmol/L | Standard Deviation 1.7 |
| SAD Group I 100mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Sodium. SAD Group | Change from BL at FU | 0.8 mmol/L | Standard Deviation 1.3 |
| SAD Group II 300mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Sodium. SAD Group | Baseline (pre-dose Day 1) | 142.0 mmol/L | Standard Deviation 0.8 |
| SAD Group II 300mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Sodium. SAD Group | Change from BL at FU | -2.0 mmol/L | Standard Deviation 0.8 |
| SAD Group II 300mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Sodium. SAD Group | Change from BL at 24h | -1.0 mmol/L | Standard Deviation 0.8 |
| SAD Group I 800mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Sodium. SAD Group | Change from BL at FU | 0.5 mmol/L | Standard Deviation 2.4 |
| SAD Group I 800mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Sodium. SAD Group | Change from BL at 24h | 0.5 mmol/L | Standard Deviation 0.6 |
| SAD Group I 800mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Sodium. SAD Group | Baseline (pre-dose Day 1) | 142.3 mmol/L | Standard Deviation 1.3 |
| SAD Group II 2000mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Sodium. SAD Group | Change from BL at 24h | -1.3 mmol/L | Standard Deviation 1 |
| SAD Group II 2000mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Sodium. SAD Group | Change from BL at FU | -2.8 mmol/L | Standard Deviation 1.3 |
| SAD Group II 2000mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Sodium. SAD Group | Baseline (pre-dose Day 1) | 143.3 mmol/L | Standard Deviation 1 |
| Group I Placebo + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Sodium. SAD Group | Baseline (pre-dose Day 1) | 139.5 mmol/L | Standard Deviation 0.7 |
| Group I Placebo + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Sodium. SAD Group | Change from BL at 24h | 2.5 mmol/L | Standard Deviation 2.1 |
| Group I Placebo + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Sodium. SAD Group | Change from BL at FU | 4.5 mmol/L | Standard Deviation 0.7 |
| Group I 100mg + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Sodium. SAD Group | Change from BL at FU | 1.8 mmol/L | Standard Deviation 0.5 |
| Group I 100mg + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Sodium. SAD Group | Change from BL at 24h | 1.0 mmol/L | Standard Deviation 2.6 |
| Group I 100mg + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Sodium. SAD Group | Baseline (pre-dose Day 1) | 140.5 mmol/L | Standard Deviation 1 |
Primary
Change From Baseline in Chemistry Laboratory Test Results by Time Point: Thyroid-stimulating Hormone. MAD Group
Blood samples were collected from participants at the indicated timepoints for evaluation of chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time frame: Baseline, Day 3, Day 8, FU (one week after last dosing)
Population: The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Thyroid-stimulating Hormone. MAD Group | Baseline (pre-dose Day 1) | 1.41 mU/L | Standard Deviation 0.78 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Thyroid-stimulating Hormone. MAD Group | Change from BL at Day 3 | 0.11 mU/L | Standard Deviation 0.33 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Thyroid-stimulating Hormone. MAD Group | Change from BL at Day 8 | 0.28 mU/L | Standard Deviation 0.35 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Thyroid-stimulating Hormone. MAD Group | Change from BL at FU | 0.16 mU/L | Standard Deviation 0.5 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Thyroid-stimulating Hormone. MAD Group | Change from BL at Day 3 | 0.09 mU/L | Standard Deviation 0.21 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Thyroid-stimulating Hormone. MAD Group | Change from BL at Day 8 | 0.45 mU/L | Standard Deviation 0.23 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Thyroid-stimulating Hormone. MAD Group | Change from BL at FU | -0.15 mU/L | Standard Deviation 0.29 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Thyroid-stimulating Hormone. MAD Group | Baseline (pre-dose Day 1) | 1.48 mU/L | Standard Deviation 0.45 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Thyroid-stimulating Hormone. MAD Group | Change from BL at Day 8 | 0.75 mU/L | Standard Deviation 0.52 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Thyroid-stimulating Hormone. MAD Group | Change from BL at Day 3 | 0.48 mU/L | Standard Deviation 0.54 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Thyroid-stimulating Hormone. MAD Group | Change from BL at FU | 0.05 mU/L | Standard Deviation 0.48 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Thyroid-stimulating Hormone. MAD Group | Baseline (pre-dose Day 1) | 1.20 mU/L | Standard Deviation 0.36 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Thyroid-stimulating Hormone. MAD Group | Change from BL at FU | 0.05 mU/L | Standard Deviation 0.39 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Thyroid-stimulating Hormone. MAD Group | Change from BL at Day 3 | 0.25 mU/L | Standard Deviation 0.39 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Thyroid-stimulating Hormone. MAD Group | Baseline (pre-dose Day 1) | 1.58 mU/L | Standard Deviation 0.41 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Thyroid-stimulating Hormone. MAD Group | Change from BL at Day 8 | 0.85 mU/L | Standard Deviation 0.54 |
Primary
Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Thyroid-stimulating Hormone. SAD Group
Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time frame: Baseline (pre-dose Day 1), 24h post dose, FU (7 days post dose)
Population: The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Thyroid-stimulating Hormone. SAD Group | Baseline (pre-dose Day 1) | 1.45 mU/L | Standard Deviation 0.56 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Thyroid-stimulating Hormone. SAD Group | Change from BL at FU | 0.08 mU/L | Standard Deviation 0.35 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Thyroid-stimulating Hormone. SAD Group | Change from BL at 24h | -0.20 mU/L | Standard Deviation 0.09 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Thyroid-stimulating Hormone. SAD Group | Change from BL at 24h | 0.04 mU/L | Standard Deviation 0.29 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Thyroid-stimulating Hormone. SAD Group | Change from BL at FU | 0.45 mU/L | Standard Deviation 1.02 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Thyroid-stimulating Hormone. SAD Group | Baseline (pre-dose Day 1) | 1.26 mU/L | Standard Deviation 0.64 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Thyroid-stimulating Hormone. SAD Group | Change from BL at FU | 0.10 mU/L | Standard Deviation 0.22 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Thyroid-stimulating Hormone. SAD Group | Baseline (pre-dose Day 1) | 1.14 mU/L | Standard Deviation 0.36 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Thyroid-stimulating Hormone. SAD Group | Change from BL at 24h | -0.12 mU/L | Standard Deviation 0.22 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Thyroid-stimulating Hormone. SAD Group | Change from BL at FU | 0.77 mU/L | Standard Deviation 0.92 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Thyroid-stimulating Hormone. SAD Group | Baseline (pre-dose Day 1) | 1.14 mU/L | Standard Deviation 0.55 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Thyroid-stimulating Hormone. SAD Group | Change from BL at 24h | -0.03 mU/L | Standard Deviation 0.18 |
| SAD Group I 100mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Thyroid-stimulating Hormone. SAD Group | Baseline (pre-dose Day 1) | 1.50 mU/L | Standard Deviation 0.97 |
| SAD Group I 100mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Thyroid-stimulating Hormone. SAD Group | Change from BL at 24h | 0.07 mU/L | Standard Deviation 0.22 |
| SAD Group I 100mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Thyroid-stimulating Hormone. SAD Group | Change from BL at FU | 0.32 mU/L | Standard Deviation 0.27 |
| SAD Group II 300mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Thyroid-stimulating Hormone. SAD Group | Change from BL at 24h | 0.46 mU/L | Standard Deviation 0.52 |
| SAD Group II 300mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Thyroid-stimulating Hormone. SAD Group | Baseline (pre-dose Day 1) | 1.55 mU/L | Standard Deviation 0.66 |
| SAD Group II 300mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Thyroid-stimulating Hormone. SAD Group | Change from BL at FU | 0.11 mU/L | Standard Deviation 0.58 |
| SAD Group I 800mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Thyroid-stimulating Hormone. SAD Group | Baseline (pre-dose Day 1) | 1.83 mU/L | Standard Deviation 0.78 |
| SAD Group I 800mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Thyroid-stimulating Hormone. SAD Group | Change from BL at FU | 0.17 mU/L | Standard Deviation 0.42 |
| SAD Group I 800mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Thyroid-stimulating Hormone. SAD Group | Change from BL at 24h | 0.05 mU/L | Standard Deviation 0.35 |
| SAD Group II 2000mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Thyroid-stimulating Hormone. SAD Group | Change from BL at 24h | -0.12 mU/L | Standard Deviation 0.25 |
| SAD Group II 2000mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Thyroid-stimulating Hormone. SAD Group | Baseline (pre-dose Day 1) | 1.59 mU/L | Standard Deviation 1.03 |
| SAD Group II 2000mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Thyroid-stimulating Hormone. SAD Group | Change from BL at FU | -0.06 mU/L | Standard Deviation 0.21 |
| Group I Placebo + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Thyroid-stimulating Hormone. SAD Group | Change from BL at 24h | -0.54 mU/L | Standard Deviation 0.65 |
| Group I Placebo + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Thyroid-stimulating Hormone. SAD Group | Baseline (pre-dose Day 1) | 2.57 mU/L | Standard Deviation 2.31 |
| Group I Placebo + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Thyroid-stimulating Hormone. SAD Group | Change from BL at FU | -0.69 mU/L | Standard Deviation 0.73 |
| Group I 100mg + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Thyroid-stimulating Hormone. SAD Group | Baseline (pre-dose Day 1) | 1.93 mU/L | Standard Deviation 0.95 |
| Group I 100mg + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Thyroid-stimulating Hormone. SAD Group | Change from BL at FU | -0.10 mU/L | Standard Deviation 0.22 |
| Group I 100mg + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Thyroid-stimulating Hormone. SAD Group | Change from BL at 24h | -0.42 mU/L | Standard Deviation 0.42 |
Primary
Change From Baseline in Chemistry Laboratory Test Results by Time Point: Thyroxine (T4). MAD Group
Blood samples were collected from participants at the indicated timepoints for evaluation of chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time frame: Baseline, Day 3, Day 8, FU (one week after last dosing)
Population: The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Thyroxine (T4). MAD Group | Baseline (pre-dose Day 1) | 1.20 ng/dL | Standard Deviation 0.08 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Thyroxine (T4). MAD Group | Change from BL at Day 3 | 0.05 ng/dL | Standard Deviation 0.06 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Thyroxine (T4). MAD Group | Change from BL at Day 8 | 0.12 ng/dL | Standard Deviation 0.05 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Thyroxine (T4). MAD Group | Change from BL at FU | 0.12 ng/dL | Standard Deviation 0.05 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Thyroxine (T4). MAD Group | Change from BL at Day 3 | 0.02 ng/dL | Standard Deviation 0.05 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Thyroxine (T4). MAD Group | Change from BL at Day 8 | 0.07 ng/dL | Standard Deviation 0.1 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Thyroxine (T4). MAD Group | Change from BL at FU | 0.03 ng/dL | Standard Deviation 0.1 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Thyroxine (T4). MAD Group | Baseline (pre-dose Day 1) | 1.25 ng/dL | Standard Deviation 0.06 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Thyroxine (T4). MAD Group | Change from BL at Day 8 | 0.23 ng/dL | Standard Deviation 0.1 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Thyroxine (T4). MAD Group | Change from BL at Day 3 | 0.05 ng/dL | Standard Deviation 0.06 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Thyroxine (T4). MAD Group | Change from BL at FU | 0.12 ng/dL | Standard Deviation 0.05 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Thyroxine (T4). MAD Group | Baseline (pre-dose Day 1) | 1.20 ng/dL | Standard Deviation 0.18 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Thyroxine (T4). MAD Group | Change from BL at FU | 0.10 ng/dL | Standard Deviation 0.06 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Thyroxine (T4). MAD Group | Change from BL at Day 3 | 0.03 ng/dL | Standard Deviation 0.08 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Thyroxine (T4). MAD Group | Baseline (pre-dose Day 1) | 1.07 ng/dL | Standard Deviation 0.14 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Thyroxine (T4). MAD Group | Change from BL at Day 8 | 0.17 ng/dL | Standard Deviation 0.1 |
Primary
Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Thyroxine (T4). SAD Group
Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time frame: Baseline (pre-dose Day 1), 24h post dose, FU (7 days post dose)
Population: The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Thyroxine (T4). SAD Group | Baseline (pre-dose Day 1) | 1.27 ng/dL | Standard Deviation 0.14 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Thyroxine (T4). SAD Group | Change from BL at FU | 0.03 ng/dL | Standard Deviation 0.1 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Thyroxine (T4). SAD Group | Change from BL at 24h | -0.05 ng/dL | Standard Deviation 0.08 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Thyroxine (T4). SAD Group | Change from BL at 24h | 0.03 ng/dL | Standard Deviation 0.05 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Thyroxine (T4). SAD Group | Change from BL at FU | 0.15 ng/dL | Standard Deviation 0.1 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Thyroxine (T4). SAD Group | Baseline (pre-dose Day 1) | 1.22 ng/dL | Standard Deviation 0.16 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Thyroxine (T4). SAD Group | Change from BL at FU | 0.02 ng/dL | Standard Deviation 0.22 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Thyroxine (T4). SAD Group | Baseline (pre-dose Day 1) | 1.30 ng/dL | Standard Deviation 0.14 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Thyroxine (T4). SAD Group | Change from BL at 24h | -0.08 ng/dL | Standard Deviation 0.1 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Thyroxine (T4). SAD Group | Change from BL at FU | 0.05 ng/dL | Standard Deviation 0.06 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Thyroxine (T4). SAD Group | Baseline (pre-dose Day 1) | 1.38 ng/dL | Standard Deviation 0.17 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Thyroxine (T4). SAD Group | Change from BL at 24h | -0.08 ng/dL | Standard Deviation 0.1 |
| SAD Group I 100mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Thyroxine (T4). SAD Group | Baseline (pre-dose Day 1) | 1.25 ng/dL | Standard Deviation 0.1 |
| SAD Group I 100mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Thyroxine (T4). SAD Group | Change from BL at 24h | -0.05 ng/dL | Standard Deviation 0.06 |
| SAD Group I 100mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Thyroxine (T4). SAD Group | Change from BL at FU | 0.07 ng/dL | Standard Deviation 0.05 |
| SAD Group II 300mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Thyroxine (T4). SAD Group | Change from BL at 24h | 0.12 ng/dL | Standard Deviation 0.05 |
| SAD Group II 300mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Thyroxine (T4). SAD Group | Baseline (pre-dose Day 1) | 1.08 ng/dL | Standard Deviation 0.05 |
| SAD Group II 300mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Thyroxine (T4). SAD Group | Change from BL at FU | 0.22 ng/dL | Standard Deviation 0.05 |
| SAD Group I 800mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Thyroxine (T4). SAD Group | Baseline (pre-dose Day 1) | 1.20 ng/dL | Standard Deviation 0.14 |
| SAD Group I 800mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Thyroxine (T4). SAD Group | Change from BL at FU | 0.05 ng/dL | Standard Deviation 0.1 |
| SAD Group I 800mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Thyroxine (T4). SAD Group | Change from BL at 24h | 0.05 ng/dL | Standard Deviation 0.13 |
| SAD Group II 2000mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Thyroxine (T4). SAD Group | Change from BL at 24h | 0.10 ng/dL | Standard Deviation 0.08 |
| SAD Group II 2000mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Thyroxine (T4). SAD Group | Baseline (pre-dose Day 1) | 1.15 ng/dL | Standard Deviation 0.06 |
| SAD Group II 2000mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Thyroxine (T4). SAD Group | Change from BL at FU | 0.13 ng/dL | Standard Deviation 0.05 |
| Group I Placebo + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Thyroxine (T4). SAD Group | Change from BL at 24h | 0.05 ng/dL | Standard Deviation 0.07 |
| Group I Placebo + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Thyroxine (T4). SAD Group | Baseline (pre-dose Day 1) | 1.35 ng/dL | Standard Deviation 0.07 |
| Group I Placebo + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Thyroxine (T4). SAD Group | Change from BL at FU | -0.10 ng/dL | Standard Deviation 0.14 |
| Group I 100mg + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Thyroxine (T4). SAD Group | Baseline (pre-dose Day 1) | 1.22 ng/dL | Standard Deviation 0.17 |
| Group I 100mg + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Thyroxine (T4). SAD Group | Change from BL at FU | 0.10 ng/dL | Standard Deviation 0.08 |
| Group I 100mg + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Thyroxine (T4). SAD Group | Change from BL at 24h | 0.03 ng/dL | Standard Deviation 0.13 |
Primary
Change From Baseline in Chemistry Laboratory Test Results by Time Point: Total Bilirubin. MAD Group
Blood samples were collected from participants at the indicated timepoints for evaluation of chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time frame: Baseline, Day 3, Day 8, FU (one week after last dosing)
Population: The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Total Bilirubin. MAD Group | Baseline (pre-dose Day 1) | 0.50 mg/dL | Standard Deviation 0.47 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Total Bilirubin. MAD Group | Change from BL at Day 3 | 0.38 mg/dL | Standard Deviation 0.22 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Total Bilirubin. MAD Group | Change from BL at Day 8 | 0.33 mg/dL | Standard Deviation 0.26 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Total Bilirubin. MAD Group | Change from BL at FU | -0.02 mg/dL | Standard Deviation 0.32 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Total Bilirubin. MAD Group | Change from BL at Day 3 | 0.05 mg/dL | Standard Deviation 0.13 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Total Bilirubin. MAD Group | Change from BL at Day 8 | 0.03 mg/dL | Standard Deviation 0.21 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Total Bilirubin. MAD Group | Change from BL at FU | -0.08 mg/dL | Standard Deviation 0.21 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Total Bilirubin. MAD Group | Baseline (pre-dose Day 1) | 0.55 mg/dL | Standard Deviation 0.13 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Total Bilirubin. MAD Group | Change from BL at Day 8 | 0.18 mg/dL | Standard Deviation 0.25 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Total Bilirubin. MAD Group | Change from BL at Day 3 | 0.20 mg/dL | Standard Deviation 0.16 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Total Bilirubin. MAD Group | Change from BL at FU | 0.08 mg/dL | Standard Deviation 0.22 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Total Bilirubin. MAD Group | Baseline (pre-dose Day 1) | 0.63 mg/dL | Standard Deviation 0.15 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Total Bilirubin. MAD Group | Change from BL at FU | -0.05 mg/dL | Standard Deviation 0.19 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Total Bilirubin. MAD Group | Change from BL at Day 3 | 0.13 mg/dL | Standard Deviation 0.08 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Total Bilirubin. MAD Group | Baseline (pre-dose Day 1) | 0.65 mg/dL | Standard Deviation 0.29 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Total Bilirubin. MAD Group | Change from BL at Day 8 | 0.08 mg/dL | Standard Deviation 0.08 |
Primary
Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Total Bilirubin. SAD Group
Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time frame: Baseline (pre-dose Day 1), 24h post dose, FU (7 days post dose)
Population: The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Total Bilirubin. SAD Group | Baseline (pre-dose Day 1) | 0.82 mg/dL | Standard Deviation 0.32 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Total Bilirubin. SAD Group | Change from BL at FU | 0.13 mg/dL | Standard Deviation 0.42 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Total Bilirubin. SAD Group | Change from BL at 24h | 0.30 mg/dL | Standard Deviation 0.26 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Total Bilirubin. SAD Group | Change from BL at 24h | 0.12 mg/dL | Standard Deviation 0.08 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Total Bilirubin. SAD Group | Change from BL at FU | -0.02 mg/dL | Standard Deviation 0.4 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Total Bilirubin. SAD Group | Baseline (pre-dose Day 1) | 0.75 mg/dL | Standard Deviation 0.6 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Total Bilirubin. SAD Group | Change from BL at FU | 0.05 mg/dL | Standard Deviation 0.13 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Total Bilirubin. SAD Group | Baseline (pre-dose Day 1) | 1.03 mg/dL | Standard Deviation 0.83 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Total Bilirubin. SAD Group | Change from BL at 24h | 0.40 mg/dL | Standard Deviation 0.08 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Total Bilirubin. SAD Group | Change from BL at FU | 0.13 mg/dL | Standard Deviation 0.13 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Total Bilirubin. SAD Group | Baseline (pre-dose Day 1) | 0.68 mg/dL | Standard Deviation 0.33 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Total Bilirubin. SAD Group | Change from BL at 24h | 0.38 mg/dL | Standard Deviation 0.13 |
| SAD Group I 100mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Total Bilirubin. SAD Group | Baseline (pre-dose Day 1) | 1.18 mg/dL | Standard Deviation 1.03 |
| SAD Group I 100mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Total Bilirubin. SAD Group | Change from BL at 24h | -0.00 mg/dL | Standard Deviation 0.18 |
| SAD Group I 100mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Total Bilirubin. SAD Group | Change from BL at FU | -0.18 mg/dL | Standard Deviation 0.33 |
| SAD Group II 300mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Total Bilirubin. SAD Group | Change from BL at 24h | 0.28 mg/dL | Standard Deviation 0.1 |
| SAD Group II 300mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Total Bilirubin. SAD Group | Baseline (pre-dose Day 1) | 0.53 mg/dL | Standard Deviation 0.13 |
| SAD Group II 300mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Total Bilirubin. SAD Group | Change from BL at FU | 0.20 mg/dL | Standard Deviation 0.18 |
| SAD Group I 800mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Total Bilirubin. SAD Group | Baseline (pre-dose Day 1) | 0.63 mg/dL | Standard Deviation 0.22 |
| SAD Group I 800mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Total Bilirubin. SAD Group | Change from BL at FU | 0.00 mg/dL | Standard Deviation 0.29 |
| SAD Group I 800mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Total Bilirubin. SAD Group | Change from BL at 24h | -0.03 mg/dL | Standard Deviation 0.15 |
| SAD Group II 2000mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Total Bilirubin. SAD Group | Change from BL at 24h | 0.31 mg/dL | Standard Deviation 0.09 |
| SAD Group II 2000mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Total Bilirubin. SAD Group | Baseline (pre-dose Day 1) | 0.31 mg/dL | Standard Deviation 0.19 |
| SAD Group II 2000mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Total Bilirubin. SAD Group | Change from BL at FU | 0.21 mg/dL | Standard Deviation 0.1 |
| Group I Placebo + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Total Bilirubin. SAD Group | Change from BL at 24h | 0.15 mg/dL | Standard Deviation 0.07 |
| Group I Placebo + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Total Bilirubin. SAD Group | Baseline (pre-dose Day 1) | 0.45 mg/dL | Standard Deviation 0.21 |
| Group I Placebo + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Total Bilirubin. SAD Group | Change from BL at FU | 0.10 mg/dL | Standard Deviation 0.14 |
| Group I 100mg + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Total Bilirubin. SAD Group | Baseline (pre-dose Day 1) | 1.10 mg/dL | Standard Deviation 1.33 |
| Group I 100mg + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Total Bilirubin. SAD Group | Change from BL at FU | -0.10 mg/dL | Standard Deviation 0.56 |
| Group I 100mg + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Total Bilirubin. SAD Group | Change from BL at 24h | 0.27 mg/dL | Standard Deviation 0.17 |
Primary
Change From Baseline in Chemistry Laboratory Test Results by Time Point: Total Protein. MAD Group
Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time frame: Baseline (pre-dose Day1), Day 3, Day 8, FU (one week after last dosing)
Population: The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Total Protein. MAD Group | Change from BL at FU | 5.0 g/L | Standard Deviation 3.4 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Total Protein. MAD Group | Change from BL at Day 8 | 7.0 g/L | Standard Deviation 2.9 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Total Protein. MAD Group | Baseline (pre-dose Day 1) | 65.3 g/L | Standard Deviation 3.8 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Total Protein. MAD Group | Change from BL at Day 3 | 4.0 g/L | Standard Deviation 2.4 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Total Protein. MAD Group | Change from BL at Day 3 | 2.3 g/L | Standard Deviation 1.7 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Total Protein. MAD Group | Baseline (pre-dose Day 1) | 67.3 g/L | Standard Deviation 4.6 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Total Protein. MAD Group | Change from BL at Day 8 | 4.3 g/L | Standard Deviation 4.3 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Total Protein. MAD Group | Change from BL at FU | 4.8 g/L | Standard Deviation 4.1 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Total Protein. MAD Group | Change from BL at Day 8 | 6.0 g/L | Standard Deviation 4.1 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Total Protein. MAD Group | Change from BL at FU | 4.0 g/L | Standard Deviation 2.9 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Total Protein. MAD Group | Change from BL at Day 3 | 2.5 g/L | Standard Deviation 1.7 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Total Protein. MAD Group | Baseline (pre-dose Day 1) | 63.8 g/L | Standard Deviation 1.3 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Total Protein. MAD Group | Change from BL at FU | 1.8 g/L | Standard Deviation 2 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Total Protein. MAD Group | Baseline (pre-dose Day 1) | 66.0 g/L | Standard Deviation 2.1 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Total Protein. MAD Group | Change from BL at Day 3 | 1.7 g/L | Standard Deviation 2.3 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Total Protein. MAD Group | Change from BL at Day 8 | 4.8 g/L | Standard Deviation 1.7 |
Primary
Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Total Protein. SAD Group
Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time frame: Baseline (pre-dose Day 1), 24h post dose, FU (7 days post dose)
Population: The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Total Protein. SAD Group | Change from BL at 24h | 1.3 g/L | Standard Deviation 2.7 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Total Protein. SAD Group | Baseline (pre-dose Day 1) | 67.5 g/L | Standard Deviation 4.9 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Total Protein. SAD Group | Change from BL at FU | 1.5 g/L | Standard Deviation 2.9 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Total Protein. SAD Group | Change from BL at 24h | 3.7 g/L | Standard Deviation 3.6 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Total Protein. SAD Group | Baseline (pre-dose Day 1) | 65.5 g/L | Standard Deviation 5.2 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Total Protein. SAD Group | Change from BL at FU | 3.3 g/L | Standard Deviation 3.1 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Total Protein. SAD Group | Change from BL at 24h | 1.5 g/L | Standard Deviation 1 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Total Protein. SAD Group | Baseline (pre-dose Day 1) | 67.0 g/L | Standard Deviation 4.1 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Total Protein. SAD Group | Change from BL at FU | 4.0 g/L | Standard Deviation 2.2 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Total Protein. SAD Group | Change from BL at FU | 1.8 g/L | Standard Deviation 3.9 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Total Protein. SAD Group | Change from BL at 24h | 3.0 g/L | Standard Deviation 2.4 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Total Protein. SAD Group | Baseline (pre-dose Day 1) | 67.3 g/L | Standard Deviation 2.2 |
| SAD Group I 100mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Total Protein. SAD Group | Change from BL at 24h | 2.8 g/L | Standard Deviation 4 |
| SAD Group I 100mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Total Protein. SAD Group | Change from BL at FU | 3.3 g/L | Standard Deviation 1.7 |
| SAD Group I 100mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Total Protein. SAD Group | Baseline (pre-dose Day 1) | 65.3 g/L | Standard Deviation 5 |
| SAD Group II 300mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Total Protein. SAD Group | Change from BL at 24h | 6.0 g/L | Standard Deviation 1.6 |
| SAD Group II 300mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Total Protein. SAD Group | Baseline (pre-dose Day 1) | 66.0 g/L | Standard Deviation 1.8 |
| SAD Group II 300mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Total Protein. SAD Group | Change from BL at FU | 0.8 g/L | Standard Deviation 1.7 |
| SAD Group I 800mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Total Protein. SAD Group | Change from BL at FU | 0.0 g/L | Standard Deviation 2.2 |
| SAD Group I 800mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Total Protein. SAD Group | Baseline (pre-dose Day 1) | 66.3 g/L | Standard Deviation 3.5 |
| SAD Group I 800mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Total Protein. SAD Group | Change from BL at 24h | 3.0 g/L | Standard Deviation 5 |
| SAD Group II 2000mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Total Protein. SAD Group | Baseline (pre-dose Day 1) | 66.0 g/L | Standard Deviation 1.4 |
| SAD Group II 2000mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Total Protein. SAD Group | Change from BL at FU | 4.8 g/L | Standard Deviation 3.3 |
| SAD Group II 2000mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Total Protein. SAD Group | Change from BL at 24h | 9.3 g/L | Standard Deviation 4.8 |
| Group I Placebo + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Total Protein. SAD Group | Baseline (pre-dose Day 1) | 66.5 g/L | Standard Deviation 2.1 |
| Group I Placebo + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Total Protein. SAD Group | Change from BL at FU | 1.0 g/L | Standard Deviation 1.4 |
| Group I Placebo + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Total Protein. SAD Group | Change from BL at 24h | 2.5 g/L | Standard Deviation 4.9 |
| Group I 100mg + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Total Protein. SAD Group | Change from BL at FU | 2.3 g/L | Standard Deviation 3.2 |
| Group I 100mg + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Total Protein. SAD Group | Baseline (pre-dose Day 1) | 66.3 g/L | Standard Deviation 5.4 |
| Group I 100mg + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Total Protein. SAD Group | Change from BL at 24h | 2.3 g/L | Standard Deviation 4.6 |
Primary
Change From Baseline in Chemistry Laboratory Test Results by Time Point: Triglycerides. MAD Group
Blood samples were collected from participants at the indicated timepoints for evaluation of chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time frame: Baseline, Day 3, Day 8, FU (one week after last dosing)
Population: The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Triglycerides. MAD Group | Baseline (pre-dose Day 1) | 140.3 mg/dL | Standard Deviation 77.7 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Triglycerides. MAD Group | Change from BL at Day 3 | 14.8 mg/dL | Standard Deviation 32.2 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Triglycerides. MAD Group | Change from BL at Day 8 | 17.8 mg/dL | Standard Deviation 44.2 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Triglycerides. MAD Group | Change from BL at FU | 16.0 mg/dL | Standard Deviation 52.1 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Triglycerides. MAD Group | Change from BL at Day 3 | 35.5 mg/dL | Standard Deviation 32.7 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Triglycerides. MAD Group | Change from BL at Day 8 | 46.8 mg/dL | Standard Deviation 26.9 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Triglycerides. MAD Group | Change from BL at FU | 0.5 mg/dL | Standard Deviation 33.5 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Triglycerides. MAD Group | Baseline (pre-dose Day 1) | 83.5 mg/dL | Standard Deviation 26.3 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Triglycerides. MAD Group | Change from BL at Day 8 | 69.0 mg/dL | Standard Deviation 42.1 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Triglycerides. MAD Group | Change from BL at Day 3 | 30.5 mg/dL | Standard Deviation 30 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Triglycerides. MAD Group | Change from BL at FU | 20.3 mg/dL | Standard Deviation 56.6 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Triglycerides. MAD Group | Baseline (pre-dose Day 1) | 114.0 mg/dL | Standard Deviation 74.6 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Triglycerides. MAD Group | Change from BL at FU | -8.0 mg/dL | Standard Deviation 39 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Triglycerides. MAD Group | Change from BL at Day 3 | 14.8 mg/dL | Standard Deviation 29.3 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Triglycerides. MAD Group | Baseline (pre-dose Day 1) | 90.2 mg/dL | Standard Deviation 67.5 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Triglycerides. MAD Group | Change from BL at Day 8 | 28.3 mg/dL | Standard Deviation 18.2 |
Primary
Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Triglycerides. SAD Group
Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time frame: Baseline (pre-dose Day 1), 24h post dose, FU (7 days post dose)
Population: The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Triglycerides. SAD Group | Baseline (pre-dose Day 1) | 72.8 mg/dL | Standard Deviation 19 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Triglycerides. SAD Group | Change from BL at FU | 16.5 mg/dL | Standard Deviation 24.5 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Triglycerides. SAD Group | Change from BL at 24h | 16.7 mg/dL | Standard Deviation 7.2 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Triglycerides. SAD Group | Change from BL at 24h | 19.0 mg/dL | Standard Deviation 17.3 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Triglycerides. SAD Group | Change from BL at FU | 24.5 mg/dL | Standard Deviation 58.6 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Triglycerides. SAD Group | Baseline (pre-dose Day 1) | 88.5 mg/dL | Standard Deviation 62.1 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Triglycerides. SAD Group | Change from BL at FU | 30.8 mg/dL | Standard Deviation 48.8 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Triglycerides. SAD Group | Baseline (pre-dose Day 1) | 57.3 mg/dL | Standard Deviation 13 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Triglycerides. SAD Group | Change from BL at 24h | 10.3 mg/dL | Standard Deviation 3 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Triglycerides. SAD Group | Change from BL at FU | 47.3 mg/dL | Standard Deviation 75.3 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Triglycerides. SAD Group | Baseline (pre-dose Day 1) | 84.5 mg/dL | Standard Deviation 46.8 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Triglycerides. SAD Group | Change from BL at 24h | 31.0 mg/dL | Standard Deviation 18.1 |
| SAD Group I 100mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Triglycerides. SAD Group | Baseline (pre-dose Day 1) | 72.0 mg/dL | Standard Deviation 9.6 |
| SAD Group I 100mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Triglycerides. SAD Group | Change from BL at 24h | 20.3 mg/dL | Standard Deviation 16.3 |
| SAD Group I 100mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Triglycerides. SAD Group | Change from BL at FU | 12.5 mg/dL | Standard Deviation 19.3 |
| SAD Group II 300mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Triglycerides. SAD Group | Change from BL at 24h | 22.5 mg/dL | Standard Deviation 18.4 |
| SAD Group II 300mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Triglycerides. SAD Group | Baseline (pre-dose Day 1) | 71.0 mg/dL | Standard Deviation 33.6 |
| SAD Group II 300mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Triglycerides. SAD Group | Change from BL at FU | 37.5 mg/dL | Standard Deviation 86.5 |
| SAD Group I 800mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Triglycerides. SAD Group | Baseline (pre-dose Day 1) | 76.3 mg/dL | Standard Deviation 15.7 |
| SAD Group I 800mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Triglycerides. SAD Group | Change from BL at FU | 37.8 mg/dL | Standard Deviation 47.1 |
| SAD Group I 800mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Triglycerides. SAD Group | Change from BL at 24h | 27.0 mg/dL | Standard Deviation 9.5 |
| SAD Group II 2000mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Triglycerides. SAD Group | Change from BL at 24h | -10.3 mg/dL | Standard Deviation 46.7 |
| SAD Group II 2000mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Triglycerides. SAD Group | Baseline (pre-dose Day 1) | 117.0 mg/dL | Standard Deviation 99.5 |
| SAD Group II 2000mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Triglycerides. SAD Group | Change from BL at FU | -16.5 mg/dL | Standard Deviation 48.6 |
| Group I Placebo + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Triglycerides. SAD Group | Change from BL at 24h | 1.5 mg/dL | Standard Deviation 29 |
| Group I Placebo + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Triglycerides. SAD Group | Baseline (pre-dose Day 1) | 92.5 mg/dL | Standard Deviation 57.3 |
| Group I Placebo + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Triglycerides. SAD Group | Change from BL at FU | 43.5 mg/dL | Standard Deviation 89.8 |
| Group I 100mg + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Triglycerides. SAD Group | Baseline (pre-dose Day 1) | 86.3 mg/dL | Standard Deviation 20.8 |
| Group I 100mg + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Triglycerides. SAD Group | Change from BL at FU | -1.8 mg/dL | Standard Deviation 18.6 |
| Group I 100mg + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Triglycerides. SAD Group | Change from BL at 24h | 7.8 mg/dL | Standard Deviation 20.2 |
Primary
Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Triiodothyronine (T3). SAD Group
Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time frame: Baseline (pre-dose Day 1), 24h post dose, FU (7 days post dose)
Population: The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Triiodothyronine (T3). SAD Group | Baseline (pre-dose Day 1) | 3.65 pg/mL | Standard Deviation 0.35 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Triiodothyronine (T3). SAD Group | Change from BL at FU | -0.30 pg/mL | Standard Deviation 0.28 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Triiodothyronine (T3). SAD Group | Change from BL at 24h | -0.35 pg/mL | Standard Deviation 0.28 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Triiodothyronine (T3). SAD Group | Change from BL at 24h | -0.10 pg/mL | Standard Deviation 0.24 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Triiodothyronine (T3). SAD Group | Change from BL at FU | 0.42 pg/mL | Standard Deviation 0.23 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Triiodothyronine (T3). SAD Group | Baseline (pre-dose Day 1) | 3.23 pg/mL | Standard Deviation 0.12 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Triiodothyronine (T3). SAD Group | Change from BL at FU | -0.23 pg/mL | Standard Deviation 0.13 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Triiodothyronine (T3). SAD Group | Baseline (pre-dose Day 1) | 3.73 pg/mL | Standard Deviation 0.21 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Triiodothyronine (T3). SAD Group | Change from BL at 24h | -0.22 pg/mL | Standard Deviation 0.17 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Triiodothyronine (T3). SAD Group | Change from BL at FU | 0.30 pg/mL | Standard Deviation 0.23 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Triiodothyronine (T3). SAD Group | Baseline (pre-dose Day 1) | 3.40 pg/mL | Standard Deviation 0.22 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Triiodothyronine (T3). SAD Group | Change from BL at 24h | 0.05 pg/mL | Standard Deviation 0.31 |
| SAD Group I 100mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Triiodothyronine (T3). SAD Group | Baseline (pre-dose Day 1) | 3.48 pg/mL | Standard Deviation 0.3 |
| SAD Group I 100mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Triiodothyronine (T3). SAD Group | Change from BL at 24h | -0.07 pg/mL | Standard Deviation 0.1 |
| SAD Group I 100mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Triiodothyronine (T3). SAD Group | Change from BL at FU | -0.13 pg/mL | Standard Deviation 0.17 |
| SAD Group II 300mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Triiodothyronine (T3). SAD Group | Change from BL at 24h | -0.23 pg/mL | Standard Deviation 0.1 |
| SAD Group II 300mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Triiodothyronine (T3). SAD Group | Baseline (pre-dose Day 1) | 3.18 pg/mL | Standard Deviation 0.17 |
| SAD Group II 300mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Triiodothyronine (T3). SAD Group | Change from BL at FU | 0.50 pg/mL | Standard Deviation 0.34 |
| SAD Group I 800mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Triiodothyronine (T3). SAD Group | Baseline (pre-dose Day 1) | 3.18 pg/mL | Standard Deviation 0.17 |
| SAD Group I 800mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Triiodothyronine (T3). SAD Group | Change from BL at FU | 0.05 pg/mL | Standard Deviation 0.13 |
| SAD Group I 800mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Triiodothyronine (T3). SAD Group | Change from BL at 24h | -0.23 pg/mL | Standard Deviation 0.36 |
| SAD Group II 2000mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Triiodothyronine (T3). SAD Group | Change from BL at 24h | -0.13 pg/mL | Standard Deviation 0.15 |
| SAD Group II 2000mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Triiodothyronine (T3). SAD Group | Baseline (pre-dose Day 1) | 3.33 pg/mL | Standard Deviation 0.19 |
| SAD Group II 2000mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Triiodothyronine (T3). SAD Group | Change from BL at FU | 0.20 pg/mL | Standard Deviation 0.08 |
| Group I Placebo + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Triiodothyronine (T3). SAD Group | Change from BL at 24h | -0.40 pg/mL | Standard Deviation 0 |
| Group I Placebo + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Triiodothyronine (T3). SAD Group | Baseline (pre-dose Day 1) | 3.60 pg/mL | Standard Deviation 0.14 |
| Group I Placebo + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Triiodothyronine (T3). SAD Group | Change from BL at FU | -0.30 pg/mL | Standard Deviation 0.14 |
| Group I 100mg + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Triiodothyronine (T3). SAD Group | Baseline (pre-dose Day 1) | 3.63 pg/mL | Standard Deviation 0.41 |
| Group I 100mg + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Triiodothyronine (T3). SAD Group | Change from BL at FU | -0.28 pg/mL | Standard Deviation 0.15 |
| Group I 100mg + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Triiodothyronine (T3). SAD Group | Change from BL at 24h | -0.25 pg/mL | Standard Deviation 0.17 |
Primary
Change From Baseline in Chemistry Laboratory Test Results by Time Point: Trilodothyronine (T3). MAD Group
Blood samples were collected from participants at the indicated timepoints for evaluation of chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time frame: Baseline, Day 3, Day 8, FU (one week after last dosing)
Population: The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Trilodothyronine (T3). MAD Group | Baseline (pre-dose Day 1) | 3.35 pg/mL | Standard Deviation 0.58 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Trilodothyronine (T3). MAD Group | Change from BL at Day 3 | -0.05 pg/mL | Standard Deviation 0.19 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Trilodothyronine (T3). MAD Group | Change from BL at Day 8 | -0.32 pg/mL | Standard Deviation 0.3 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Trilodothyronine (T3). MAD Group | Change from BL at FU | 0.30 pg/mL | Standard Deviation 0.26 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Trilodothyronine (T3). MAD Group | Change from BL at Day 3 | -0.28 pg/mL | Standard Deviation 0.29 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Trilodothyronine (T3). MAD Group | Change from BL at Day 8 | 0.10 pg/mL | Standard Deviation 0.27 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Trilodothyronine (T3). MAD Group | Change from BL at FU | -0.05 pg/mL | Standard Deviation 0.3 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Trilodothyronine (T3). MAD Group | Baseline (pre-dose Day 1) | 3.35 pg/mL | Standard Deviation 0.26 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Trilodothyronine (T3). MAD Group | Change from BL at Day 8 | -0.13 pg/mL | Standard Deviation 0.22 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Trilodothyronine (T3). MAD Group | Change from BL at Day 3 | -0.15 pg/mL | Standard Deviation 0.19 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Trilodothyronine (T3). MAD Group | Change from BL at FU | 0.18 pg/mL | Standard Deviation 0.29 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Trilodothyronine (T3). MAD Group | Baseline (pre-dose Day 1) | 3.30 pg/mL | Standard Deviation 0.14 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Trilodothyronine (T3). MAD Group | Change from BL at FU | 0.18 pg/mL | Standard Deviation 0.08 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Trilodothyronine (T3). MAD Group | Change from BL at Day 3 | -0.15 pg/mL | Standard Deviation 0.34 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Trilodothyronine (T3). MAD Group | Baseline (pre-dose Day 1) | 3.08 pg/mL | Standard Deviation 0.35 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Trilodothyronine (T3). MAD Group | Change from BL at Day 8 | -0.05 pg/mL | Standard Deviation 0.33 |
Primary
Change From Baseline in Chemistry Laboratory Test Results by Time Point: Urea. MAD Group
Blood samples were collected from participants at the indicated timepoints for evaluation of chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time frame: Baseline, Day 3, Day 8, FU (one week after last dosing)
Population: The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Urea. MAD Group | Baseline (pre-dose Day 1) | 24.8 mg/dL | Standard Deviation 3.9 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Urea. MAD Group | Change from BL at Day 3 | 6.0 mg/dL | Standard Deviation 2.2 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Urea. MAD Group | Change from BL at Day 8 | 5.8 mg/dL | Standard Deviation 6.9 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Urea. MAD Group | Change from BL at FU | 2.3 mg/dL | Standard Deviation 8.4 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Urea. MAD Group | Change from BL at Day 3 | 2.8 mg/dL | Standard Deviation 2.4 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Urea. MAD Group | Change from BL at Day 8 | -0.5 mg/dL | Standard Deviation 3.1 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Urea. MAD Group | Change from BL at FU | -0.5 mg/dL | Standard Deviation 6.8 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Urea. MAD Group | Baseline (pre-dose Day 1) | 28.0 mg/dL | Standard Deviation 5.5 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Urea. MAD Group | Change from BL at Day 8 | 0.5 mg/dL | Standard Deviation 1.3 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Urea. MAD Group | Change from BL at Day 3 | 2.0 mg/dL | Standard Deviation 2.6 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Urea. MAD Group | Change from BL at FU | -0.5 mg/dL | Standard Deviation 7.1 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Urea. MAD Group | Baseline (pre-dose Day 1) | 29.8 mg/dL | Standard Deviation 5.1 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Urea. MAD Group | Change from BL at FU | -0.3 mg/dL | Standard Deviation 6.7 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Urea. MAD Group | Change from BL at Day 3 | 2.5 mg/dL | Standard Deviation 3 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Urea. MAD Group | Baseline (pre-dose Day 1) | 30.2 mg/dL | Standard Deviation 3.5 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Urea. MAD Group | Change from BL at Day 8 | -1.0 mg/dL | Standard Deviation 4.5 |
Primary
Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Urea. SAD Group
Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time frame: Baseline (pre-dose Day 1), 24h post dose, FU (7 days post dose)
Population: The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Urea. SAD Group | Baseline (pre-dose Day 1) | 27.5 mg/dL | Standard Deviation 9.3 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Urea. SAD Group | Change from BL at FU | 1.2 mg/dL | Standard Deviation 7.1 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Urea. SAD Group | Change from BL at 24h | 0.0 mg/dL | Standard Deviation 3.9 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Urea. SAD Group | Change from BL at 24h | 0.2 mg/dL | Standard Deviation 4.4 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Urea. SAD Group | Change from BL at FU | 0.5 mg/dL | Standard Deviation 7.7 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Urea. SAD Group | Baseline (pre-dose Day 1) | 24.7 mg/dL | Standard Deviation 4.5 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Urea. SAD Group | Change from BL at FU | -0.8 mg/dL | Standard Deviation 3.9 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Urea. SAD Group | Baseline (pre-dose Day 1) | 30.0 mg/dL | Standard Deviation 8.4 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Urea. SAD Group | Change from BL at 24h | -2.5 mg/dL | Standard Deviation 5 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Urea. SAD Group | Change from BL at FU | 2.3 mg/dL | Standard Deviation 7.7 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Urea. SAD Group | Baseline (pre-dose Day 1) | 26.0 mg/dL | Standard Deviation 7.3 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Urea. SAD Group | Change from BL at 24h | -0.3 mg/dL | Standard Deviation 2.5 |
| SAD Group I 100mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Urea. SAD Group | Baseline (pre-dose Day 1) | 24.0 mg/dL | Standard Deviation 2.4 |
| SAD Group I 100mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Urea. SAD Group | Change from BL at 24h | 0.0 mg/dL | Standard Deviation 2.8 |
| SAD Group I 100mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Urea. SAD Group | Change from BL at FU | 0.3 mg/dL | Standard Deviation 4.5 |
| SAD Group II 300mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Urea. SAD Group | Change from BL at 24h | -0.5 mg/dL | Standard Deviation 5.2 |
| SAD Group II 300mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Urea. SAD Group | Baseline (pre-dose Day 1) | 25.3 mg/dL | Standard Deviation 4.1 |
| SAD Group II 300mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Urea. SAD Group | Change from BL at FU | -2.3 mg/dL | Standard Deviation 7.3 |
| SAD Group I 800mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Urea. SAD Group | Baseline (pre-dose Day 1) | 29.3 mg/dL | Standard Deviation 10.6 |
| SAD Group I 800mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Urea. SAD Group | Change from BL at FU | -0.3 mg/dL | Standard Deviation 5.4 |
| SAD Group I 800mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Urea. SAD Group | Change from BL at 24h | -1.0 mg/dL | Standard Deviation 4.7 |
| SAD Group II 2000mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Urea. SAD Group | Change from BL at 24h | -4.0 mg/dL | Standard Deviation 8.6 |
| SAD Group II 2000mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Urea. SAD Group | Baseline (pre-dose Day 1) | 34.8 mg/dL | Standard Deviation 7.7 |
| SAD Group II 2000mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Urea. SAD Group | Change from BL at FU | -6.8 mg/dL | Standard Deviation 11.8 |
| Group I Placebo + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Urea. SAD Group | Change from BL at 24h | -9.0 mg/dL | Standard Deviation 1.4 |
| Group I Placebo + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Urea. SAD Group | Baseline (pre-dose Day 1) | 38.5 mg/dL | Standard Deviation 6.4 |
| Group I Placebo + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Urea. SAD Group | Change from BL at FU | -8.0 mg/dL | Standard Deviation 4.2 |
| Group I 100mg + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Urea. SAD Group | Baseline (pre-dose Day 1) | 25.8 mg/dL | Standard Deviation 5.7 |
| Group I 100mg + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Urea. SAD Group | Change from BL at FU | -1.5 mg/dL | Standard Deviation 4.7 |
| Group I 100mg + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Urea. SAD Group | Change from BL at 24h | -0.5 mg/dL | Standard Deviation 3.3 |
Primary
Change From Baseline in Chemistry Laboratory Test Results by Time Point: Uric Acid. MAD Group
Blood samples were collected from participants at the indicated timepoints for evaluation of chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time frame: Baseline, Day 3, Day 8, FU (one week after last dosing)
Population: The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Uric Acid. MAD Group | Baseline (pre-dose Day 1) | 5.65 mg/dL | Standard Deviation 1.67 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Uric Acid. MAD Group | Change from BL at Day 3 | 0.50 mg/dL | Standard Deviation 0.56 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Uric Acid. MAD Group | Change from BL at Day 8 | 0.28 mg/dL | Standard Deviation 1.14 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Uric Acid. MAD Group | Change from BL at FU | 0.08 mg/dL | Standard Deviation 0.92 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Uric Acid. MAD Group | Change from BL at Day 3 | 0.58 mg/dL | Standard Deviation 0.39 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Uric Acid. MAD Group | Change from BL at Day 8 | -0.02 mg/dL | Standard Deviation 0.43 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Uric Acid. MAD Group | Change from BL at FU | 0.55 mg/dL | Standard Deviation 0.52 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Uric Acid. MAD Group | Baseline (pre-dose Day 1) | 4.93 mg/dL | Standard Deviation 0.91 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Uric Acid. MAD Group | Change from BL at Day 8 | 0.15 mg/dL | Standard Deviation 0.58 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Uric Acid. MAD Group | Change from BL at Day 3 | 0.75 mg/dL | Standard Deviation 0.62 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Uric Acid. MAD Group | Change from BL at FU | 0.22 mg/dL | Standard Deviation 0.81 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Uric Acid. MAD Group | Baseline (pre-dose Day 1) | 5.40 mg/dL | Standard Deviation 0.8 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Uric Acid. MAD Group | Change from BL at FU | -0.05 mg/dL | Standard Deviation 0.42 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Uric Acid. MAD Group | Change from BL at Day 3 | -0.07 mg/dL | Standard Deviation 0.31 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Uric Acid. MAD Group | Baseline (pre-dose Day 1) | 5.25 mg/dL | Standard Deviation 1.14 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Time Point: Uric Acid. MAD Group | Change from BL at Day 8 | -0.63 mg/dL | Standard Deviation 0.52 |
Primary
Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Uric Acid. SAD Group
Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time frame: Baseline (pre-dose Day 1), 24h post dose, FU (7 days post dose)
Population: The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Uric Acid. SAD Group | Change from BL at 24h | -0.25 mg/dL | Standard Deviation 0.4 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Uric Acid. SAD Group | Change from BL at FU | 0.28 mg/dL | Standard Deviation 0.26 |
| Group I Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Uric Acid. SAD Group | Baseline (pre-dose Day 1) | 5.52 mg/dL | Standard Deviation 0.84 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Uric Acid. SAD Group | Change from BL at 24h | -0.13 mg/dL | Standard Deviation 0.23 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Uric Acid. SAD Group | Baseline (pre-dose Day 1) | 4.85 mg/dL | Standard Deviation 0.84 |
| Group II Placebo | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Uric Acid. SAD Group | Change from BL at FU | 0.32 mg/dL | Standard Deviation 0.5 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Uric Acid. SAD Group | Change from BL at 24h | -0.28 mg/dL | Standard Deviation 0.25 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Uric Acid. SAD Group | Baseline (pre-dose Day 1) | 5.75 mg/dL | Standard Deviation 0.42 |
| SAD Group I 10mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Uric Acid. SAD Group | Change from BL at FU | 0.22 mg/dL | Standard Deviation 0.79 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Uric Acid. SAD Group | Change from BL at FU | 0.40 mg/dL | Standard Deviation 0.43 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Uric Acid. SAD Group | Change from BL at 24h | -0.20 mg/dL | Standard Deviation 0.24 |
| SAD Group II 30mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Uric Acid. SAD Group | Baseline (pre-dose Day 1) | 4.80 mg/dL | Standard Deviation 0.37 |
| SAD Group I 100mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Uric Acid. SAD Group | Change from BL at 24h | -0.30 mg/dL | Standard Deviation 0.12 |
| SAD Group I 100mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Uric Acid. SAD Group | Baseline (pre-dose Day 1) | 5.48 mg/dL | Standard Deviation 0.82 |
| SAD Group I 100mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Uric Acid. SAD Group | Change from BL at FU | 0.35 mg/dL | Standard Deviation 0.53 |
| SAD Group II 300mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Uric Acid. SAD Group | Baseline (pre-dose Day 1) | 4.75 mg/dL | Standard Deviation 0.79 |
| SAD Group II 300mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Uric Acid. SAD Group | Change from BL at 24h | -0.25 mg/dL | Standard Deviation 0.24 |
| SAD Group II 300mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Uric Acid. SAD Group | Change from BL at FU | 0.30 mg/dL | Standard Deviation 0.08 |
| SAD Group I 800mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Uric Acid. SAD Group | Change from BL at 24h | -0.20 mg/dL | Standard Deviation 0.32 |
| SAD Group I 800mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Uric Acid. SAD Group | Change from BL at FU | 0.18 mg/dL | Standard Deviation 0.68 |
| SAD Group I 800mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Uric Acid. SAD Group | Baseline (pre-dose Day 1) | 5.48 mg/dL | Standard Deviation 1.07 |
| SAD Group II 2000mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Uric Acid. SAD Group | Baseline (pre-dose Day 1) | 5.10 mg/dL | Standard Deviation 0.96 |
| SAD Group II 2000mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Uric Acid. SAD Group | Change from BL at 24h | 0.15 mg/dL | Standard Deviation 0.42 |
| SAD Group II 2000mg | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Uric Acid. SAD Group | Change from BL at FU | 0.23 mg/dL | Standard Deviation 0.22 |
| Group I Placebo + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Uric Acid. SAD Group | Change from BL at 24h | -0.60 mg/dL | Standard Deviation 0.28 |
| Group I Placebo + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Uric Acid. SAD Group | Baseline (pre-dose Day 1) | 5.45 mg/dL | Standard Deviation 0.21 |
| Group I Placebo + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Uric Acid. SAD Group | Change from BL at FU | 0.40 mg/dL | Standard Deviation 0.28 |
| Group I 100mg + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Uric Acid. SAD Group | Change from BL at FU | 0.33 mg/dL | Standard Deviation 0.51 |
| Group I 100mg + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Uric Acid. SAD Group | Change from BL at 24h | -0.28 mg/dL | Standard Deviation 0.4 |
| Group I 100mg + Food | Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Uric Acid. SAD Group | Baseline (pre-dose Day 1) | 5.50 mg/dL | Standard Deviation 1.41 |
Primary
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Basophils. MAD Group
Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time frame: Baseline (pre-dose Day 1), Day 3, Day 8, FU (7 days post dose)
Population: The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group I Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Basophils. MAD Group | Change from BL at Day 8 | 12.5 cells/µL | Standard Deviation 20.6 |
| Group I Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Basophils. MAD Group | Change from BL at FU | 7.5 cells/µL | Standard Deviation 15 |
| Group I Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Basophils. MAD Group | Change from BL at Day 3 | 7.5 cells/µL | Standard Deviation 17.1 |
| Group I Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Basophils. MAD Group | Baseline (pre-dose Day 1) | 30.0 cells/µL | Standard Deviation 8.2 |
| Group II Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Basophils. MAD Group | Change from BL at Day 3 | 8.5 cells/µL | Standard Deviation 17.4 |
| Group II Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Basophils. MAD Group | Change from BL at Day 8 | -6.5 cells/µL | Standard Deviation 17 |
| Group II Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Basophils. MAD Group | Baseline (pre-dose Day 1) | 34.0 cells/µL | Standard Deviation 10.8 |
| Group II Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Basophils. MAD Group | Change from BL at FU | 1.0 cells/µL | Standard Deviation 6.6 |
| SAD Group I 10mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Basophils. MAD Group | Change from BL at Day 8 | 5.0 cells/µL | Standard Deviation 12.9 |
| SAD Group I 10mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Basophils. MAD Group | Baseline (pre-dose Day 1) | 20.0 cells/µL | Standard Deviation 11.5 |
| SAD Group I 10mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Basophils. MAD Group | Change from BL at Day 3 | 2.5 cells/µL | Standard Deviation 5 |
| SAD Group I 10mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Basophils. MAD Group | Change from BL at FU | 2.5 cells/µL | Standard Deviation 12.6 |
| SAD Group II 30mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Basophils. MAD Group | Baseline (pre-dose Day 1) | 23.3 cells/µL | Standard Deviation 10.3 |
| SAD Group II 30mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Basophils. MAD Group | Change from BL at Day 8 | 4.0 cells/µL | Standard Deviation 14.7 |
| SAD Group II 30mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Basophils. MAD Group | Change from BL at FU | 5.0 cells/µL | Standard Deviation 18.7 |
| SAD Group II 30mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Basophils. MAD Group | Change from BL at Day 3 | 3.3 cells/µL | Standard Deviation 8.2 |
Primary
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Basophils. SAD Group
Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value ateach timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time frame: Baseline (pre-dose Day 1), 24h post dose, FU (7 days post-dose)
Population: The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group I Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Basophils. SAD Group | Change from BL at FU | 0.0 cells/µL | Standard Deviation 12.6 |
| Group I Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Basophils. SAD Group | Baseline (pre-dose Day 1) | 23.3 cells/µL | Standard Deviation 5.2 |
| Group I Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Basophils. SAD Group | Change from BL at 24h | -5.0 cells/µL | Standard Deviation 8.4 |
| Group II Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Basophils. SAD Group | Change from BL at FU | -1.7 cells/µL | Standard Deviation 7.5 |
| Group II Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Basophils. SAD Group | Change from BL at 24h | 0.0 cells/µL | Standard Deviation 8.9 |
| Group II Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Basophils. SAD Group | Baseline (pre-dose Day 1) | 25.0 cells/µL | Standard Deviation 10.5 |
| SAD Group I 10mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Basophils. SAD Group | Change from BL at FU | 5.0 cells/µL | Standard Deviation 5.8 |
| SAD Group I 10mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Basophils. SAD Group | Change from BL at 24h | 2.5 cells/µL | Standard Deviation 5 |
| SAD Group I 10mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Basophils. SAD Group | Baseline (pre-dose Day 1) | 15.0 cells/µL | Standard Deviation 5.8 |
| SAD Group II 30mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Basophils. SAD Group | Change from BL at FU | -5.0 cells/µL | Standard Deviation 10 |
| SAD Group II 30mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Basophils. SAD Group | Baseline (pre-dose Day 1) | 30.0 cells/µL | Standard Deviation 18.3 |
| SAD Group II 30mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Basophils. SAD Group | Change from BL at 24h | -7.5 cells/µL | Standard Deviation 9.6 |
| SAD Group I 100mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Basophils. SAD Group | Baseline (pre-dose Day 1) | 15.0 cells/µL | Standard Deviation 10 |
| SAD Group I 100mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Basophils. SAD Group | Change from BL at 24h | 0.0 cells/µL | Standard Deviation 0 |
| SAD Group I 100mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Basophils. SAD Group | Change from BL at FU | 7.5 cells/µL | Standard Deviation 9.6 |
| SAD Group II 300mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Basophils. SAD Group | Baseline (pre-dose Day 1) | 32.5 cells/µL | Standard Deviation 15 |
| SAD Group II 300mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Basophils. SAD Group | Change from BL at FU | -5.0 cells/µL | Standard Deviation 12.9 |
| SAD Group II 300mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Basophils. SAD Group | Change from BL at 24h | -5.0 cells/µL | Standard Deviation 10 |
| SAD Group I 800mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Basophils. SAD Group | Change from BL at FU | 20.0 cells/µL | Standard Deviation 21.6 |
| SAD Group I 800mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Basophils. SAD Group | Change from BL at 24h | 2.5 cells/µL | Standard Deviation 5 |
| SAD Group I 800mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Basophils. SAD Group | Baseline (pre-dose Day 1) | 20.0 cells/µL | Standard Deviation 11.5 |
| SAD Group II 2000mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Basophils. SAD Group | Change from BL at 24h | 5.0 cells/µL | Standard Deviation 5.8 |
| SAD Group II 2000mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Basophils. SAD Group | Change from BL at FU | 0.0 cells/µL | Standard Deviation 8.2 |
| SAD Group II 2000mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Basophils. SAD Group | Baseline (pre-dose Day 1) | 22.5 cells/µL | Standard Deviation 5 |
| Group I Placebo + Food | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Basophils. SAD Group | Change from BL at FU | -15.0 cells/µL | Standard Deviation 21.2 |
| Group I Placebo + Food | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Basophils. SAD Group | Change from BL at 24h | -20.0 cells/µL | Standard Deviation 14.1 |
| Group I Placebo + Food | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Basophils. SAD Group | Baseline (pre-dose Day 1) | 65.0 cells/µL | Standard Deviation 63.6 |
| Group I 100mg + Food | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Basophils. SAD Group | Change from BL at FU | -2.5 cells/µL | Standard Deviation 5 |
| Group I 100mg + Food | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Basophils. SAD Group | Change from BL at 24h | -2.5 cells/µL | Standard Deviation 9.6 |
| Group I 100mg + Food | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Basophils. SAD Group | Baseline (pre-dose Day 1) | 25.0 cells/µL | Standard Deviation 17.3 |
Primary
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Eosinophils. MAD Group
Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time frame: Baseline (pre-dose Day 1), Day 3, Day 8, FU (7 days post dose)
Population: The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group I Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Eosinophils. MAD Group | Baseline (pre-dose Day 1) | 212.5 cells/µL | Standard Deviation 79.3 |
| Group I Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Eosinophils. MAD Group | Change from BL at Day 3 | -40.0 cells/µL | Standard Deviation 52.3 |
| Group I Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Eosinophils. MAD Group | Change from BL at Day 8 | -47.5 cells/µL | Standard Deviation 87.3 |
| Group I Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Eosinophils. MAD Group | Change from BL at FU | -27.5 cells/µL | Standard Deviation 131.8 |
| Group II Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Eosinophils. MAD Group | Change from BL at Day 3 | -31.0 cells/µL | Standard Deviation 53.2 |
| Group II Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Eosinophils. MAD Group | Change from BL at Day 8 | -28.5 cells/µL | Standard Deviation 66 |
| Group II Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Eosinophils. MAD Group | Change from BL at FU | 31.5 cells/µL | Standard Deviation 26.5 |
| Group II Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Eosinophils. MAD Group | Baseline (pre-dose Day 1) | 183.5 cells/µL | Standard Deviation 84.6 |
| SAD Group I 10mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Eosinophils. MAD Group | Change from BL at Day 8 | -10.0 cells/µL | Standard Deviation 27.1 |
| SAD Group I 10mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Eosinophils. MAD Group | Change from BL at Day 3 | 7.5 cells/µL | Standard Deviation 20.6 |
| SAD Group I 10mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Eosinophils. MAD Group | Change from BL at FU | -17.5 cells/µL | Standard Deviation 27.5 |
| SAD Group I 10mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Eosinophils. MAD Group | Baseline (pre-dose Day 1) | 127.5 cells/µL | Standard Deviation 45.7 |
| SAD Group II 30mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Eosinophils. MAD Group | Change from BL at FU | -45.0 cells/µL | Standard Deviation 76.4 |
| SAD Group II 30mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Eosinophils. MAD Group | Change from BL at Day 3 | -28.3 cells/µL | Standard Deviation 43.6 |
| SAD Group II 30mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Eosinophils. MAD Group | Baseline (pre-dose Day 1) | 141.7 cells/µL | Standard Deviation 96.2 |
| SAD Group II 30mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Eosinophils. MAD Group | Change from BL at Day 8 | -22.7 cells/µL | Standard Deviation 56.4 |
Primary
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Eosinophils. SAD Group
Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time frame: Baseline (pre-dose Day 1), 24h post dose, FU (7 days after last dosing)
Population: The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group I Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Eosinophils. SAD Group | Change from BL at 24h | -5.0 cells/µL | Standard Deviation 16.4 |
| Group I Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Eosinophils. SAD Group | Change from BL at FU | -13.3 cells/µL | Standard Deviation 16.3 |
| Group I Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Eosinophils. SAD Group | Baseline (pre-dose Day 1) | 115.0 cells/µL | Standard Deviation 50.1 |
| Group II Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Eosinophils. SAD Group | Baseline (pre-dose Day 1) | 191.7 cells/µL | Standard Deviation 109.4 |
| Group II Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Eosinophils. SAD Group | Change from BL at FU | -58.3 cells/µL | Standard Deviation 93.5 |
| Group II Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Eosinophils. SAD Group | Change from BL at 24h | -50.0 cells/µL | Standard Deviation 40.5 |
| SAD Group I 10mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Eosinophils. SAD Group | Change from BL at FU | -17.5 cells/µL | Standard Deviation 25 |
| SAD Group I 10mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Eosinophils. SAD Group | Baseline (pre-dose Day 1) | 110.0 cells/µL | Standard Deviation 49.7 |
| SAD Group I 10mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Eosinophils. SAD Group | Change from BL at 24h | -17.5 cells/µL | Standard Deviation 9.6 |
| SAD Group II 30mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Eosinophils. SAD Group | Baseline (pre-dose Day 1) | 137.5 cells/µL | Standard Deviation 83.4 |
| SAD Group II 30mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Eosinophils. SAD Group | Change from BL at 24h | -22.5 cells/µL | Standard Deviation 42.7 |
| SAD Group II 30mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Eosinophils. SAD Group | Change from BL at FU | -12.5 cells/µL | Standard Deviation 43.5 |
| SAD Group I 100mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Eosinophils. SAD Group | Change from BL at FU | -2.5 cells/µL | Standard Deviation 18.9 |
| SAD Group I 100mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Eosinophils. SAD Group | Change from BL at 24h | -15.0 cells/µL | Standard Deviation 12.9 |
| SAD Group I 100mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Eosinophils. SAD Group | Baseline (pre-dose Day 1) | 112.5 cells/µL | Standard Deviation 36.9 |
| SAD Group II 300mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Eosinophils. SAD Group | Change from BL at FU | -42.5 cells/µL | Standard Deviation 61.3 |
| SAD Group II 300mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Eosinophils. SAD Group | Baseline (pre-dose Day 1) | 200.0 cells/µL | Standard Deviation 78.7 |
| SAD Group II 300mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Eosinophils. SAD Group | Change from BL at 24h | -37.5 cells/µL | Standard Deviation 47.9 |
| SAD Group I 800mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Eosinophils. SAD Group | Change from BL at 24h | -25.0 cells/µL | Standard Deviation 33.2 |
| SAD Group I 800mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Eosinophils. SAD Group | Baseline (pre-dose Day 1) | 245.0 cells/µL | Standard Deviation 233.6 |
| SAD Group I 800mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Eosinophils. SAD Group | Change from BL at FU | 77.5 cells/µL | Standard Deviation 201.6 |
| SAD Group II 2000mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Eosinophils. SAD Group | Change from BL at 24h | -25.0 cells/µL | Standard Deviation 26.5 |
| SAD Group II 2000mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Eosinophils. SAD Group | Change from BL at FU | -20.0 cells/µL | Standard Deviation 18.3 |
| SAD Group II 2000mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Eosinophils. SAD Group | Baseline (pre-dose Day 1) | 110.0 cells/µL | Standard Deviation 71.6 |
| Group I Placebo + Food | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Eosinophils. SAD Group | Change from BL at 24h | -25.0 cells/µL | Standard Deviation 7.1 |
| Group I Placebo + Food | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Eosinophils. SAD Group | Baseline (pre-dose Day 1) | 650.0 cells/µL | Standard Deviation 792 |
| Group I Placebo + Food | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Eosinophils. SAD Group | Change from BL at FU | -125.0 cells/µL | Standard Deviation 205.1 |
| Group I 100mg + Food | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Eosinophils. SAD Group | Change from BL at FU | -42.5 cells/µL | Standard Deviation 42.7 |
| Group I 100mg + Food | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Eosinophils. SAD Group | Baseline (pre-dose Day 1) | 152.5 cells/µL | Standard Deviation 81 |
| Group I 100mg + Food | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Eosinophils. SAD Group | Change from BL at 24h | -30.0 cells/µL | Standard Deviation 47.6 |
Primary
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Erythrocyte Sedimentation Rate MAD Group
Time frame: Baseline (pre-dose Day 1), Day 3, Day 8, FU (7 days after last dosing)
Population: The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group I Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Erythrocyte Sedimentation Rate MAD Group | Change from BL at FU | 5.0 mm/hr | Standard Deviation 8.2 |
| Group I Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Erythrocyte Sedimentation Rate MAD Group | Change from BL at Day 3 | 2.0 mm/hr | Standard Deviation 3.5 |
| Group I Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Erythrocyte Sedimentation Rate MAD Group | Baseline (pre-dose Day 1) | 4.0 mm/hr | Standard Deviation 2.4 |
| Group I Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Erythrocyte Sedimentation Rate MAD Group | Change from BL at Day 8 | 4.8 mm/hr | Standard Deviation 5.7 |
| Group II Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Erythrocyte Sedimentation Rate MAD Group | Change from BL at Day 8 | 0.8 mm/hr | Standard Deviation 2.2 |
| Group II Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Erythrocyte Sedimentation Rate MAD Group | Change from BL at FU | 1.3 mm/hr | Standard Deviation 1.3 |
| Group II Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Erythrocyte Sedimentation Rate MAD Group | Baseline (pre-dose Day 1) | 3.0 mm/hr | Standard Deviation 1.8 |
| Group II Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Erythrocyte Sedimentation Rate MAD Group | Change from BL at Day 3 | 0.8 mm/hr | Standard Deviation 0.5 |
| SAD Group I 10mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Erythrocyte Sedimentation Rate MAD Group | Change from BL at FU | 1.0 mm/hr | Standard Deviation 0.8 |
| SAD Group I 10mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Erythrocyte Sedimentation Rate MAD Group | Change from BL at Day 3 | 0.5 mm/hr | Standard Deviation 0.6 |
| SAD Group I 10mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Erythrocyte Sedimentation Rate MAD Group | Baseline (pre-dose Day 1) | 2.0 mm/hr | Standard Deviation 1.4 |
| SAD Group I 10mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Erythrocyte Sedimentation Rate MAD Group | Change from BL at Day 8 | 2.5 mm/hr | Standard Deviation 1.7 |
| SAD Group II 30mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Erythrocyte Sedimentation Rate MAD Group | Baseline (pre-dose Day 1) | 2.7 mm/hr | Standard Deviation 1.8 |
| SAD Group II 30mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Erythrocyte Sedimentation Rate MAD Group | Change from BL at FU | 2.2 mm/hr | Standard Deviation 3.5 |
| SAD Group II 30mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Erythrocyte Sedimentation Rate MAD Group | Change from BL at Day 3 | 0.8 mm/hr | Standard Deviation 1.7 |
| SAD Group II 30mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Erythrocyte Sedimentation Rate MAD Group | Change from BL at Day 8 | 0.3 mm/hr | Standard Deviation 1.4 |
Primary
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Erythrocyte Sedimentation Rate (SAD Group)
Time frame: Baseline (pre-dose Day1), 24h post dose, FU (7 days after last dosing)
Population: The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group I Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Erythrocyte Sedimentation Rate (SAD Group) | Change from BL at FU | 0.3 mm/hr | Standard Deviation 1.2 |
| Group I Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Erythrocyte Sedimentation Rate (SAD Group) | Change from BL at 24h | 0.5 mm/hr | Standard Deviation 0.5 |
| Group I Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Erythrocyte Sedimentation Rate (SAD Group) | Baseline | 2.3 mm/hr | Standard Deviation 1.4 |
| Group II Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Erythrocyte Sedimentation Rate (SAD Group) | Change from BL at 24h | 0.3 mm/hr | Standard Deviation 1 |
| Group II Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Erythrocyte Sedimentation Rate (SAD Group) | Baseline | 2.8 mm/hr | Standard Deviation 2.1 |
| Group II Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Erythrocyte Sedimentation Rate (SAD Group) | Change from BL at FU | 0.3 mm/hr | Standard Deviation 1.5 |
| SAD Group I 10mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Erythrocyte Sedimentation Rate (SAD Group) | Change from BL at 24h | 0.0 mm/hr | Standard Deviation 0 |
| SAD Group I 10mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Erythrocyte Sedimentation Rate (SAD Group) | Change from BL at FU | 0.8 mm/hr | Standard Deviation 1 |
| SAD Group I 10mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Erythrocyte Sedimentation Rate (SAD Group) | Baseline | 1.3 mm/hr | Standard Deviation 0.5 |
| SAD Group II 30mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Erythrocyte Sedimentation Rate (SAD Group) | Change from BL at FU | 0.5 mm/hr | Standard Deviation 1.7 |
| SAD Group II 30mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Erythrocyte Sedimentation Rate (SAD Group) | Change from BL at 24h | 1.0 mm/hr | Standard Deviation 0.8 |
| SAD Group II 30mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Erythrocyte Sedimentation Rate (SAD Group) | Baseline | 1.8 mm/hr | Standard Deviation 1 |
| SAD Group I 100mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Erythrocyte Sedimentation Rate (SAD Group) | Change from BL at 24h | 0.0 mm/hr | Standard Deviation 0.8 |
| SAD Group I 100mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Erythrocyte Sedimentation Rate (SAD Group) | Change from BL at FU | 0.5 mm/hr | Standard Deviation 1.7 |
| SAD Group I 100mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Erythrocyte Sedimentation Rate (SAD Group) | Baseline | 2.0 mm/hr | Standard Deviation 1.4 |
| SAD Group II 300mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Erythrocyte Sedimentation Rate (SAD Group) | Change from BL at FU | 0.0 mm/hr | Standard Deviation 0 |
| SAD Group II 300mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Erythrocyte Sedimentation Rate (SAD Group) | Baseline | 3.0 mm/hr | Standard Deviation 4 |
| SAD Group II 300mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Erythrocyte Sedimentation Rate (SAD Group) | Change from BL at 24h | 0.3 mm/hr | Standard Deviation 1 |
| SAD Group I 800mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Erythrocyte Sedimentation Rate (SAD Group) | Change from BL at FU | -2.3 mm/hr | Standard Deviation 6.8 |
| SAD Group I 800mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Erythrocyte Sedimentation Rate (SAD Group) | Baseline | 7.3 mm/hr | Standard Deviation 8.5 |
| SAD Group I 800mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Erythrocyte Sedimentation Rate (SAD Group) | Change from BL at 24h | 0.3 mm/hr | Standard Deviation 0.6 |
| SAD Group II 2000mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Erythrocyte Sedimentation Rate (SAD Group) | Baseline | 4.0 mm/hr | Standard Deviation 3.2 |
| SAD Group II 2000mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Erythrocyte Sedimentation Rate (SAD Group) | Change from BL at FU | 0.5 mm/hr | Standard Deviation 1 |
| SAD Group II 2000mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Erythrocyte Sedimentation Rate (SAD Group) | Change from BL at 24h | 3.0 mm/hr | Standard Deviation 3.6 |
| Group I Placebo + Food | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Erythrocyte Sedimentation Rate (SAD Group) | Change from BL at 24h | -0.5 mm/hr | Standard Deviation 0.7 |
| Group I Placebo + Food | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Erythrocyte Sedimentation Rate (SAD Group) | Baseline | 5.0 mm/hr | Standard Deviation 2.8 |
| Group I Placebo + Food | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Erythrocyte Sedimentation Rate (SAD Group) | Change from BL at FU | 0.0 mm/hr | Standard Deviation 0 |
| Group I 100mg + Food | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Erythrocyte Sedimentation Rate (SAD Group) | Change from BL at FU | 0.0 mm/hr | Standard Deviation 0 |
| Group I 100mg + Food | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Erythrocyte Sedimentation Rate (SAD Group) | Change from BL at 24h | 1.0 mm/hr | Standard Deviation 2 |
| Group I 100mg + Food | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Erythrocyte Sedimentation Rate (SAD Group) | Baseline | 2.5 mm/hr | Standard Deviation 3 |
Primary
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Hematocrit MAD Group
Hematocrit is a measure of the ratio of red blood cells (RBCs) in the blood by volume. Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value
Time frame: Baseline (pre-dose Day 1), Day 3, Day 8, FU (7 days post dose)
Population: The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group I Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Hematocrit MAD Group | Baseline | 39.93 % of red cells to volume of whole blood. | Standard Deviation 1.2 |
| Group I Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Hematocrit MAD Group | Change from BL at FU | 0.92 % of red cells to volume of whole blood. | Standard Deviation 1.06 |
| Group I Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Hematocrit MAD Group | Change from BL at Day 8 | 3.30 % of red cells to volume of whole blood. | Standard Deviation 1.24 |
| Group I Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Hematocrit MAD Group | Change from BL at Day 3 | 2.67 % of red cells to volume of whole blood. | Standard Deviation 1.94 |
| Group II Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Hematocrit MAD Group | Baseline | 43.40 % of red cells to volume of whole blood. | Standard Deviation 3.51 |
| Group II Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Hematocrit MAD Group | Change from BL at Day 8 | 1.22 % of red cells to volume of whole blood. | Standard Deviation 3.26 |
| Group II Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Hematocrit MAD Group | Change from BL at FU | -0.10 % of red cells to volume of whole blood. | Standard Deviation 3.26 |
| Group II Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Hematocrit MAD Group | Change from BL at Day 3 | 1.17 % of red cells to volume of whole blood. | Standard Deviation 1.69 |
| SAD Group I 10mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Hematocrit MAD Group | Change from BL at FU | -1.05 % of red cells to volume of whole blood. | Standard Deviation 0.64 |
| SAD Group I 10mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Hematocrit MAD Group | Baseline | 45.10 % of red cells to volume of whole blood. | Standard Deviation 1.33 |
| SAD Group I 10mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Hematocrit MAD Group | Change from BL at Day 3 | 0.13 % of red cells to volume of whole blood. | Standard Deviation 0.45 |
| SAD Group I 10mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Hematocrit MAD Group | Change from BL at Day 8 | 0.10 % of red cells to volume of whole blood. | Standard Deviation 1.22 |
| SAD Group II 30mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Hematocrit MAD Group | Change from BL at Day 8 | 1.93 % of red cells to volume of whole blood. | Standard Deviation 2.69 |
| SAD Group II 30mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Hematocrit MAD Group | Baseline | 43.30 % of red cells to volume of whole blood. | Standard Deviation 1.95 |
| SAD Group II 30mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Hematocrit MAD Group | Change from BL at Day 3 | 1.70 % of red cells to volume of whole blood. | Standard Deviation 1.91 |
| SAD Group II 30mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Hematocrit MAD Group | Change from BL at FU | -0.75 % of red cells to volume of whole blood. | Standard Deviation 2.32 |
Primary
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Hematocrit SAD Group
Hematocrit is a measure of the ratio of red blood cells (RBCs) in the blood by volume. Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time frame: Baseline (pre-dose Day 1), 24 h postdose, FU (7 days after last dosing)
Population: The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group I Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Hematocrit SAD Group | Change from BL at 24h | 0.53 %red cells to the volume of whole blood. | Standard Deviation 1.28 |
| Group I Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Hematocrit SAD Group | Baseline (pre-dose Day 1) | 43.77 %red cells to the volume of whole blood. | Standard Deviation 3.35 |
| Group I Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Hematocrit SAD Group | Change from BL at FU | -0.43 %red cells to the volume of whole blood. | Standard Deviation 1.7 |
| Group II Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Hematocrit SAD Group | Change from BL at 24h | 0.60 %red cells to the volume of whole blood. | Standard Deviation 2.1 |
| Group II Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Hematocrit SAD Group | Baseline (pre-dose Day 1) | 43.13 %red cells to the volume of whole blood. | Standard Deviation 2.79 |
| Group II Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Hematocrit SAD Group | Change from BL at FU | -0.65 %red cells to the volume of whole blood. | Standard Deviation 1.37 |
| SAD Group I 10mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Hematocrit SAD Group | Change from BL at 24h | 0.75 %red cells to the volume of whole blood. | Standard Deviation 0.91 |
| SAD Group I 10mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Hematocrit SAD Group | Baseline (pre-dose Day 1) | 43.10 %red cells to the volume of whole blood. | Standard Deviation 3.46 |
| SAD Group I 10mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Hematocrit SAD Group | Change from BL at FU | 0.85 %red cells to the volume of whole blood. | Standard Deviation 1.45 |
| SAD Group II 30mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Hematocrit SAD Group | Change from BL at FU | -0.93 %red cells to the volume of whole blood. | Standard Deviation 1.91 |
| SAD Group II 30mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Hematocrit SAD Group | Baseline (pre-dose Day 1) | 44.38 %red cells to the volume of whole blood. | Standard Deviation 3.28 |
| SAD Group II 30mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Hematocrit SAD Group | Change from BL at 24h | 1.95 %red cells to the volume of whole blood. | Standard Deviation 1.41 |
| SAD Group I 100mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Hematocrit SAD Group | Baseline (pre-dose Day 1) | 42.98 %red cells to the volume of whole blood. | Standard Deviation 1.41 |
| SAD Group I 100mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Hematocrit SAD Group | Change from BL at FU | 0.10 %red cells to the volume of whole blood. | Standard Deviation 1.66 |
| SAD Group I 100mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Hematocrit SAD Group | Change from BL at 24h | 1.42 %red cells to the volume of whole blood. | Standard Deviation 2.12 |
| SAD Group II 300mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Hematocrit SAD Group | Change from BL at FU | -2.02 %red cells to the volume of whole blood. | Standard Deviation 0.54 |
| SAD Group II 300mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Hematocrit SAD Group | Change from BL at 24h | 1.03 %red cells to the volume of whole blood. | Standard Deviation 2.11 |
| SAD Group II 300mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Hematocrit SAD Group | Baseline (pre-dose Day 1) | 44.35 %red cells to the volume of whole blood. | Standard Deviation 2.88 |
| SAD Group I 800mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Hematocrit SAD Group | Baseline (pre-dose Day 1) | 44.05 %red cells to the volume of whole blood. | Standard Deviation 3.17 |
| SAD Group I 800mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Hematocrit SAD Group | Change from BL at FU | -1.15 %red cells to the volume of whole blood. | Standard Deviation 2.17 |
| SAD Group I 800mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Hematocrit SAD Group | Change from BL at 24h | 1.33 %red cells to the volume of whole blood. | Standard Deviation 1.8 |
| SAD Group II 2000mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Hematocrit SAD Group | Change from BL at FU | 0.07 %red cells to the volume of whole blood. | Standard Deviation 1.41 |
| SAD Group II 2000mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Hematocrit SAD Group | Baseline (pre-dose Day 1) | 41.35 %red cells to the volume of whole blood. | Standard Deviation 1.68 |
| SAD Group II 2000mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Hematocrit SAD Group | Change from BL at 24h | 2.33 %red cells to the volume of whole blood. | Standard Deviation 1.87 |
| Group I Placebo + Food | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Hematocrit SAD Group | Baseline (pre-dose Day 1) | 44.35 %red cells to the volume of whole blood. | Standard Deviation 2.33 |
| Group I Placebo + Food | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Hematocrit SAD Group | Change from BL at 24h | 1.90 %red cells to the volume of whole blood. | Standard Deviation 0.28 |
| Group I Placebo + Food | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Hematocrit SAD Group | Change from BL at FU | -0.65 %red cells to the volume of whole blood. | Standard Deviation 3.04 |
| Group I 100mg + Food | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Hematocrit SAD Group | Change from BL at FU | 0.55 %red cells to the volume of whole blood. | Standard Deviation 2.2 |
| Group I 100mg + Food | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Hematocrit SAD Group | Change from BL at 24h | 0.68 %red cells to the volume of whole blood. | Standard Deviation 1.92 |
| Group I 100mg + Food | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Hematocrit SAD Group | Baseline (pre-dose Day 1) | 42.53 %red cells to the volume of whole blood. | Standard Deviation 1.5 |
Primary
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Hemoglobin. MAD Group
Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time frame: Baseline (pre-dose Day 1), Day 3, Day 8, FU (7 days post dose)
Population: The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group I Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Hemoglobin. MAD Group | Change from BL at Day 3 | 1.05 g/dL | Standard Deviation 0.66 |
| Group I Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Hemoglobin. MAD Group | Change from BL at Day 8 | 1.35 g/dL | Standard Deviation 0.37 |
| Group I Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Hemoglobin. MAD Group | Change from BL at FU | 0.30 g/dL | Standard Deviation 0.49 |
| Group I Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Hemoglobin. MAD Group | Baseline (pre-dose Day 1) | 13.68 g/dL | Standard Deviation 0.59 |
| Group II Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Hemoglobin. MAD Group | Baseline (pre-dose Day 1) | 15.23 g/dL | Standard Deviation 1.38 |
| Group II Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Hemoglobin. MAD Group | Change from BL at Day 3 | 0.42 g/dL | Standard Deviation 0.74 |
| Group II Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Hemoglobin. MAD Group | Change from BL at Day 8 | 0.55 g/dL | Standard Deviation 1.22 |
| Group II Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Hemoglobin. MAD Group | Change from BL at FU | -0.05 g/dL | Standard Deviation 1.11 |
| SAD Group I 10mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Hemoglobin. MAD Group | Baseline (pre-dose Day 1) | 15.68 g/dL | Standard Deviation 0.64 |
| SAD Group I 10mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Hemoglobin. MAD Group | Change from BL at Day 3 | 0.17 g/dL | Standard Deviation 0.22 |
| SAD Group I 10mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Hemoglobin. MAD Group | Change from BL at Day 8 | 0.27 g/dL | Standard Deviation 0.6 |
| SAD Group I 10mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Hemoglobin. MAD Group | Change from BL at FU | -0.38 g/dL | Standard Deviation 0.47 |
| SAD Group II 30mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Hemoglobin. MAD Group | Change from BL at Day 8 | 0.75 g/dL | Standard Deviation 0.83 |
| SAD Group II 30mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Hemoglobin. MAD Group | Change from BL at Day 3 | 0.62 g/dL | Standard Deviation 0.5 |
| SAD Group II 30mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Hemoglobin. MAD Group | Change from BL at FU | -0.35 g/dL | Standard Deviation 0.63 |
| SAD Group II 30mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Hemoglobin. MAD Group | Baseline (pre-dose Day 1) | 14.82 g/dL | Standard Deviation 0.67 |
Primary
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Lymphocytes. MAD Group
Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time frame: Baseline (pre-dose Day 1), Day 3, Day 8, FU (7 days post dose)
Population: The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group I Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Lymphocytes. MAD Group | Change from BL at Day 3 | 87.5 cells/µL | Standard Deviation 177.8 |
| Group I Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Lymphocytes. MAD Group | Change from BL at Day 8 | 12.5 cells/µL | Standard Deviation 378.5 |
| Group I Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Lymphocytes. MAD Group | Baseline (pre-dose Day 1) | 1627.5 cells/µL | Standard Deviation 656 |
| Group I Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Lymphocytes. MAD Group | Change from BL at FU | -55.0 cells/µL | Standard Deviation 257.5 |
| Group II Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Lymphocytes. MAD Group | Change from BL at FU | 39.0 cells/µL | Standard Deviation 382.3 |
| Group II Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Lymphocytes. MAD Group | Baseline (pre-dose Day 1) | 1498.5 cells/µL | Standard Deviation 125.1 |
| Group II Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Lymphocytes. MAD Group | Change from BL at Day 8 | 124.0 cells/µL | Standard Deviation 148.8 |
| Group II Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Lymphocytes. MAD Group | Change from BL at Day 3 | 159.0 cells/µL | Standard Deviation 188.6 |
| SAD Group I 10mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Lymphocytes. MAD Group | Change from BL at Day 8 | 237.5 cells/µL | Standard Deviation 208.1 |
| SAD Group I 10mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Lymphocytes. MAD Group | Baseline (pre-dose Day 1) | 1750.0 cells/µL | Standard Deviation 187.4 |
| SAD Group I 10mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Lymphocytes. MAD Group | Change from BL at Day 3 | 390.0 cells/µL | Standard Deviation 297.4 |
| SAD Group I 10mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Lymphocytes. MAD Group | Change from BL at FU | 262.5 cells/µL | Standard Deviation 220.2 |
| SAD Group II 30mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Lymphocytes. MAD Group | Change from BL at Day 8 | 283.3 cells/µL | Standard Deviation 402.6 |
| SAD Group II 30mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Lymphocytes. MAD Group | Change from BL at FU | 5.0 cells/µL | Standard Deviation 465.9 |
| SAD Group II 30mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Lymphocytes. MAD Group | Baseline (pre-dose Day 1) | 1508.3 cells/µL | Standard Deviation 317.1 |
| SAD Group II 30mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Lymphocytes. MAD Group | Change from BL at Day 3 | 215.0 cells/µL | Standard Deviation 372.3 |
Primary
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Lymphocytes. SAD Group
Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time frame: Baseline (pre-dose Day 1), 24h post dose, FU (7 days post dose)
Population: The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group I Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Lymphocytes. SAD Group | Change from BL at FU | 86.7 cells/µL | Standard Deviation 265.3 |
| Group I Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Lymphocytes. SAD Group | Change from BL at 24h | -13.3 cells/µL | Standard Deviation 223.4 |
| Group I Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Lymphocytes. SAD Group | Baseline (pre-dose Day 1) | 1570.0 cells/µL | Standard Deviation 227 |
| Group II Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Lymphocytes. SAD Group | Baseline (pre-dose Day 1) | 1748.3 cells/µL | Standard Deviation 441.1 |
| Group II Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Lymphocytes. SAD Group | Change from BL at 24h | -16.7 cells/µL | Standard Deviation 347.3 |
| Group II Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Lymphocytes. SAD Group | Change from BL at FU | -45.0 cells/µL | Standard Deviation 253.3 |
| SAD Group I 10mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Lymphocytes. SAD Group | Change from BL at FU | 180.0 cells/µL | Standard Deviation 186.5 |
| SAD Group I 10mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Lymphocytes. SAD Group | Baseline (pre-dose Day 1) | 1655.0 cells/µL | Standard Deviation 200.4 |
| SAD Group I 10mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Lymphocytes. SAD Group | Change from BL at 24h | -45.0 cells/µL | Standard Deviation 192.8 |
| SAD Group II 30mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Lymphocytes. SAD Group | Baseline (pre-dose Day 1) | 1862.5 cells/µL | Standard Deviation 548.2 |
| SAD Group II 30mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Lymphocytes. SAD Group | Change from BL at 24h | -172.5 cells/µL | Standard Deviation 227.1 |
| SAD Group II 30mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Lymphocytes. SAD Group | Change from BL at FU | -92.5 cells/µL | Standard Deviation 315.7 |
| SAD Group I 100mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Lymphocytes. SAD Group | Change from BL at FU | 127.5 cells/µL | Standard Deviation 425.2 |
| SAD Group I 100mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Lymphocytes. SAD Group | Change from BL at 24h | -27.5 cells/µL | Standard Deviation 58 |
| SAD Group I 100mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Lymphocytes. SAD Group | Baseline (pre-dose Day 1) | 1485.0 cells/µL | Standard Deviation 169.2 |
| SAD Group II 300mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Lymphocytes. SAD Group | Change from BL at 24h | 92.5 cells/µL | Standard Deviation 225.6 |
| SAD Group II 300mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Lymphocytes. SAD Group | Baseline (pre-dose Day 1) | 1570.0 cells/µL | Standard Deviation 273.1 |
| SAD Group II 300mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Lymphocytes. SAD Group | Change from BL at FU | -32.5 cells/µL | Standard Deviation 174.6 |
| SAD Group I 800mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Lymphocytes. SAD Group | Change from BL at 24h | 287.5 cells/µL | Standard Deviation 353.7 |
| SAD Group I 800mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Lymphocytes. SAD Group | Baseline (pre-dose Day 1) | 1550.0 cells/µL | Standard Deviation 275.3 |
| SAD Group I 800mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Lymphocytes. SAD Group | Change from BL at FU | 135.0 cells/µL | Standard Deviation 294.2 |
| SAD Group II 2000mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Lymphocytes. SAD Group | Change from BL at 24h | 37.5 cells/µL | Standard Deviation 159.9 |
| SAD Group II 2000mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Lymphocytes. SAD Group | Change from BL at FU | -7.5 cells/µL | Standard Deviation 244 |
| SAD Group II 2000mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Lymphocytes. SAD Group | Baseline (pre-dose Day 1) | 1497.5 cells/µL | Standard Deviation 707.6 |
| Group I Placebo + Food | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Lymphocytes. SAD Group | Change from BL at 24h | -135.0 cells/µL | Standard Deviation 261.6 |
| Group I Placebo + Food | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Lymphocytes. SAD Group | Baseline (pre-dose Day 1) | 2260.0 cells/µL | Standard Deviation 975.8 |
| Group I Placebo + Food | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Lymphocytes. SAD Group | Change from BL at FU | -190.0 cells/µL | Standard Deviation 410.1 |
| Group I 100mg + Food | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Lymphocytes. SAD Group | Change from BL at 24h | -70.0 cells/µL | Standard Deviation 177.6 |
| Group I 100mg + Food | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Lymphocytes. SAD Group | Baseline (pre-dose Day 1) | 1640.0 cells/µL | Standard Deviation 243.2 |
| Group I 100mg + Food | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Lymphocytes. SAD Group | Change from BL at FU | -27.5 cells/µL | Standard Deviation 125.8 |
Primary
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Haemoglobin Concentration. MAD Group
Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time frame: Baseline (pre-dose Day 1), Day 3, Day 8, FU (7 days post dose)
Population: The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group I Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Haemoglobin Concentration. MAD Group | Baseline (pre-dose Day 1) | 34.28 g/dL RBC | Standard Deviation 1.08 |
| Group I Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Haemoglobin Concentration. MAD Group | Change from BL at Day 3 | 0.30 g/dL RBC | Standard Deviation 0.22 |
| Group I Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Haemoglobin Concentration. MAD Group | Change from BL at Day 8 | 0.47 g/dL RBC | Standard Deviation 0.43 |
| Group I Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Haemoglobin Concentration. MAD Group | Change from BL at FU | -0.08 g/dL RBC | Standard Deviation 0.33 |
| Group II Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Haemoglobin Concentration. MAD Group | Baseline (pre-dose Day 1) | 35.05 g/dL RBC | Standard Deviation 0.37 |
| Group II Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Haemoglobin Concentration. MAD Group | Change from BL at FU | 0.00 g/dL RBC | Standard Deviation 0.27 |
| Group II Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Haemoglobin Concentration. MAD Group | Change from BL at Day 3 | 0.05 g/dL RBC | Standard Deviation 0.62 |
| Group II Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Haemoglobin Concentration. MAD Group | Change from BL at Day 8 | 0.25 g/dL RBC | Standard Deviation 0.26 |
| SAD Group I 10mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Haemoglobin Concentration. MAD Group | Change from BL at Day 3 | 0.30 g/dL RBC | Standard Deviation 0.39 |
| SAD Group I 10mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Haemoglobin Concentration. MAD Group | Change from BL at Day 8 | 0.50 g/dL RBC | Standard Deviation 0.44 |
| SAD Group I 10mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Haemoglobin Concentration. MAD Group | Change from BL at FU | 0.00 g/dL RBC | Standard Deviation 0.65 |
| SAD Group I 10mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Haemoglobin Concentration. MAD Group | Baseline (pre-dose Day 1) | 34.75 g/dL RBC | Standard Deviation 0.62 |
| SAD Group II 30mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Haemoglobin Concentration. MAD Group | Baseline (pre-dose Day 1) | 34.23 g/dL RBC | Standard Deviation 0.37 |
| SAD Group II 30mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Haemoglobin Concentration. MAD Group | Change from BL at Day 8 | 0.17 g/dL RBC | Standard Deviation 0.38 |
| SAD Group II 30mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Haemoglobin Concentration. MAD Group | Change from BL at Day 3 | 0.08 g/dL RBC | Standard Deviation 0.48 |
| SAD Group II 30mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Haemoglobin Concentration. MAD Group | Change from BL at FU | -0.22 g/dL RBC | Standard Deviation 0.44 |
Primary
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Haemoglobin. SAD
Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time frame: Baseline (pre-dose Day 1), 24 h post dose, FU (7 days after last dosing)
Population: The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group I Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Haemoglobin. SAD | Baseline (pre-dose Day 1) | 30.32 pg/cell | Standard Deviation 1.83 |
| Group I Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Haemoglobin. SAD | Change from BL at 24h - Day 1 | 0.08 pg/cell | Standard Deviation 0.34 |
| Group I Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Haemoglobin. SAD | Change from BL at FU | -0.22 pg/cell | Standard Deviation 0.15 |
| Group II Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Haemoglobin. SAD | Change from BL at 24h - Day 1 | 0.23 pg/cell | Standard Deviation 0.59 |
| Group II Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Haemoglobin. SAD | Baseline (pre-dose Day 1) | 29.70 pg/cell | Standard Deviation 0.98 |
| Group II Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Haemoglobin. SAD | Change from BL at FU | 0.05 pg/cell | Standard Deviation 0.46 |
| SAD Group I 10mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Haemoglobin. SAD | Change from BL at 24h - Day 1 | 0.17 pg/cell | Standard Deviation 0.26 |
| SAD Group I 10mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Haemoglobin. SAD | Baseline (pre-dose Day 1) | 30.78 pg/cell | Standard Deviation 1.71 |
| SAD Group I 10mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Haemoglobin. SAD | Change from BL at FU | -0.28 pg/cell | Standard Deviation 0.57 |
| SAD Group II 30mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Haemoglobin. SAD | Baseline (pre-dose Day 1) | 30.38 pg/cell | Standard Deviation 0.49 |
| SAD Group II 30mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Haemoglobin. SAD | Change from BL at FU | -0.23 pg/cell | Standard Deviation 0.51 |
| SAD Group II 30mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Haemoglobin. SAD | Change from BL at 24h - Day 1 | -0.08 pg/cell | Standard Deviation 0.26 |
| SAD Group I 100mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Haemoglobin. SAD | Change from BL at FU | -0.42 pg/cell | Standard Deviation 0.37 |
| SAD Group I 100mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Haemoglobin. SAD | Baseline (pre-dose Day 1) | 30.00 pg/cell | Standard Deviation 1.75 |
| SAD Group I 100mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Haemoglobin. SAD | Change from BL at 24h - Day 1 | -0.15 pg/cell | Standard Deviation 0.13 |
| SAD Group II 300mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Haemoglobin. SAD | Baseline (pre-dose Day 1) | 29.63 pg/cell | Standard Deviation 0.68 |
| SAD Group II 300mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Haemoglobin. SAD | Change from BL at FU | -0.28 pg/cell | Standard Deviation 0.21 |
| SAD Group II 300mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Haemoglobin. SAD | Change from BL at 24h - Day 1 | -0.60 pg/cell | Standard Deviation 0.8 |
| SAD Group I 800mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Haemoglobin. SAD | Baseline (pre-dose Day 1) | 30.28 pg/cell | Standard Deviation 1.26 |
| SAD Group I 800mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Haemoglobin. SAD | Change from BL at FU | -0.58 pg/cell | Standard Deviation 0.22 |
| SAD Group I 800mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Haemoglobin. SAD | Change from BL at 24h - Day 1 | -0.25 pg/cell | Standard Deviation 0.37 |
| SAD Group II 2000mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Haemoglobin. SAD | Change from BL at FU | 0.12 pg/cell | Standard Deviation 0.39 |
| SAD Group II 2000mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Haemoglobin. SAD | Change from BL at 24h - Day 1 | 0.33 pg/cell | Standard Deviation 0.41 |
| SAD Group II 2000mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Haemoglobin. SAD | Baseline (pre-dose Day 1) | 29.80 pg/cell | Standard Deviation 1.16 |
| Group I Placebo + Food | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Haemoglobin. SAD | Baseline (pre-dose Day 1) | 30.25 pg/cell | Standard Deviation 1.77 |
| Group I Placebo + Food | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Haemoglobin. SAD | Change from BL at FU | -0.15 pg/cell | Standard Deviation 0.35 |
| Group I Placebo + Food | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Haemoglobin. SAD | Change from BL at 24h - Day 1 | 0.25 pg/cell | Standard Deviation 0.64 |
| Group I 100mg + Food | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Haemoglobin. SAD | Change from BL at 24h - Day 1 | 0.20 pg/cell | Standard Deviation 0.34 |
| Group I 100mg + Food | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Haemoglobin. SAD | Baseline (pre-dose Day 1) | 29.65 pg/cell | Standard Deviation 2.13 |
| Group I 100mg + Food | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Haemoglobin. SAD | Change from BL at FU | -0.08 pg/cell | Standard Deviation 0.15 |
Primary
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Hemoglobin Concentration - SAD
Erythrocyte mean corpuscular hemoglobin concentration (MCHC) is a measure of the average concentration of hemoglobin per red blood cell. Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time frame: Baseline (pre-dose Day 1), 24 h post dose, FU (7 days after last dosing)
Population: The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group I Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Hemoglobin Concentration - SAD | Baseline (pre-dose Day 1) | 34.15 g/dL RBC | Standard Deviation 0.34 |
| Group I Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Hemoglobin Concentration - SAD | Change from BL at FU | 0.17 g/dL RBC | Standard Deviation 0.62 |
| Group I Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Hemoglobin Concentration - SAD | Change from BL at 24h - Day 1 | -0.07 g/dL RBC | Standard Deviation 0.32 |
| Group II Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Hemoglobin Concentration - SAD | Change from BL at FU | 0.47 g/dL RBC | Standard Deviation 0.42 |
| Group II Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Hemoglobin Concentration - SAD | Baseline (pre-dose Day 1) | 33.98 g/dL RBC | Standard Deviation 1.01 |
| Group II Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Hemoglobin Concentration - SAD | Change from BL at 24h - Day 1 | 0.43 g/dL RBC | Standard Deviation 0.42 |
| SAD Group I 10mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Hemoglobin Concentration - SAD | Baseline (pre-dose Day 1) | 34.18 g/dL RBC | Standard Deviation 0.46 |
| SAD Group I 10mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Hemoglobin Concentration - SAD | Change from BL at FU | 0.27 g/dL RBC | Standard Deviation 0.54 |
| SAD Group I 10mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Hemoglobin Concentration - SAD | Change from BL at 24h - Day 1 | 0.00 g/dL RBC | Standard Deviation 0.35 |
| SAD Group II 30mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Hemoglobin Concentration - SAD | Change from BL at 24h - Day 1 | -0.27 g/dL RBC | Standard Deviation 0.39 |
| SAD Group II 30mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Hemoglobin Concentration - SAD | Change from BL at FU | 0.18 g/dL RBC | Standard Deviation 0.6 |
| SAD Group II 30mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Hemoglobin Concentration - SAD | Baseline (pre-dose Day 1) | 34.38 g/dL RBC | Standard Deviation 0.84 |
| SAD Group I 100mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Hemoglobin Concentration - SAD | Change from BL at FU | -0.05 g/dL RBC | Standard Deviation 0.64 |
| SAD Group I 100mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Hemoglobin Concentration - SAD | Baseline (pre-dose Day 1) | 34.53 g/dL RBC | Standard Deviation 0.45 |
| SAD Group I 100mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Hemoglobin Concentration - SAD | Change from BL at 24h - Day 1 | -0.17 g/dL RBC | Standard Deviation 0.15 |
| SAD Group II 300mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Hemoglobin Concentration - SAD | Change from BL at FU | 0.30 g/dL RBC | Standard Deviation 0.48 |
| SAD Group II 300mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Hemoglobin Concentration - SAD | Baseline (pre-dose Day 1) | 34.33 g/dL RBC | Standard Deviation 1.07 |
| SAD Group II 300mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Hemoglobin Concentration - SAD | Change from BL at 24h - Day 1 | -1.05 g/dL RBC | Standard Deviation 0.87 |
| SAD Group I 800mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Hemoglobin Concentration - SAD | Change from BL at FU | -0.13 g/dL RBC | Standard Deviation 0.61 |
| SAD Group I 800mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Hemoglobin Concentration - SAD | Baseline (pre-dose Day 1) | 34.20 g/dL RBC | Standard Deviation 0.65 |
| SAD Group I 800mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Hemoglobin Concentration - SAD | Change from BL at 24h - Day 1 | -0.20 g/dL RBC | Standard Deviation 0.42 |
| SAD Group II 2000mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Hemoglobin Concentration - SAD | Baseline (pre-dose Day 1) | 33.25 g/dL RBC | Standard Deviation 0.71 |
| SAD Group II 2000mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Hemoglobin Concentration - SAD | Change from BL at FU | 1.00 g/dL RBC | Standard Deviation 0.12 |
| SAD Group II 2000mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Hemoglobin Concentration - SAD | Change from BL at 24h - Day 1 | 0.82 g/dL RBC | Standard Deviation 0.29 |
| Group I Placebo + Food | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Hemoglobin Concentration - SAD | Change from BL at 24h - Day 1 | 0.10 g/dL RBC | Standard Deviation 0.57 |
| Group I Placebo + Food | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Hemoglobin Concentration - SAD | Change from BL at FU | -0.60 g/dL RBC | Standard Deviation 0.28 |
| Group I Placebo + Food | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Hemoglobin Concentration - SAD | Baseline (pre-dose Day 1) | 34.70 g/dL RBC | Standard Deviation 0.57 |
| Group I 100mg + Food | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Hemoglobin Concentration - SAD | Change from BL at FU | -0.20 g/dL RBC | Standard Deviation 0.42 |
| Group I 100mg + Food | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Hemoglobin Concentration - SAD | Change from BL at 24h - Day 1 | 0.45 g/dL RBC | Standard Deviation 0.68 |
| Group I 100mg + Food | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Hemoglobin Concentration - SAD | Baseline (pre-dose Day 1) | 34.68 g/dL RBC | Standard Deviation 0.99 |
Primary
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Hemoglobin. MAD Group
Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time frame: Baseline (pre-dose Day 1), Day 3, Day 8, FU (7 days post dose)
Population: The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group I Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Hemoglobin. MAD Group | Change from BL at Day 3 | 0.25 pg/cell | Standard Deviation 0.13 |
| Group I Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Hemoglobin. MAD Group | Baseline (pre-dose Day 1) | 29.80 pg/cell | Standard Deviation 0.91 |
| Group I Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Hemoglobin. MAD Group | Change from BL at Day 8 | 0.40 pg/cell | Standard Deviation 0.4 |
| Group I Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Hemoglobin. MAD Group | Change from BL at FU | 0.15 pg/cell | Standard Deviation 0.47 |
| Group II Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Hemoglobin. MAD Group | Change from BL at FU | -0.20 pg/cell | Standard Deviation 0.08 |
| Group II Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Hemoglobin. MAD Group | Baseline (pre-dose Day 1) | 31.33 pg/cell | Standard Deviation 1.24 |
| Group II Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Hemoglobin. MAD Group | Change from BL at Day 3 | 0.23 pg/cell | Standard Deviation 0.39 |
| Group II Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Hemoglobin. MAD Group | Change from BL at Day 8 | 0.12 pg/cell | Standard Deviation 0.22 |
| SAD Group I 10mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Hemoglobin. MAD Group | Baseline (pre-dose Day 1) | 30.03 pg/cell | Standard Deviation 0.49 |
| SAD Group I 10mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Hemoglobin. MAD Group | Change from BL at FU | 0.40 pg/cell | Standard Deviation 0.41 |
| SAD Group I 10mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Hemoglobin. MAD Group | Change from BL at Day 3 | 0.45 pg/cell | Standard Deviation 0.26 |
| SAD Group I 10mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Hemoglobin. MAD Group | Change from BL at Day 8 | 0.57 pg/cell | Standard Deviation 0.62 |
| SAD Group II 30mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Hemoglobin. MAD Group | Baseline (pre-dose Day 1) | 30.47 pg/cell | Standard Deviation 0.97 |
| SAD Group II 30mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Hemoglobin. MAD Group | Change from BL at Day 8 | 0.25 pg/cell | Standard Deviation 0.33 |
| SAD Group II 30mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Hemoglobin. MAD Group | Change from BL at Day 3 | 0.20 pg/cell | Standard Deviation 0.25 |
| SAD Group II 30mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Hemoglobin. MAD Group | Change from BL at FU | 0.02 pg/cell | Standard Deviation 0.25 |
Primary
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Volume. MAD Group
Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time frame: Baseline (pre-dose Day 1), Day 3, Day 8, FU (7 days post dose)
Population: The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group I Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Volume. MAD Group | Baseline (pre-dose Day 1) | 87.00 fL | Standard Deviation 0.62 |
| Group I Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Volume. MAD Group | Change from BL at Day 3 | -0.05 fL | Standard Deviation 0.4 |
| Group I Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Volume. MAD Group | Change from BL at FU | 0.60 fL | Standard Deviation 0.74 |
| Group I Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Volume. MAD Group | Change from BL at Day 8 | -0.10 fL | Standard Deviation 1.3 |
| Group II Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Volume. MAD Group | Change from BL at Day 8 | -0.43 fL | Standard Deviation 0.28 |
| Group II Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Volume. MAD Group | Change from BL at FU | -0.55 fL | Standard Deviation 0.73 |
| Group II Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Volume. MAD Group | Baseline (pre-dose Day 1) | 89.32 fL | Standard Deviation 2.73 |
| Group II Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Volume. MAD Group | Change from BL at Day 3 | 0.52 fL | Standard Deviation 1.15 |
| SAD Group I 10mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Volume. MAD Group | Change from BL at FU | 1.22 fL | Standard Deviation 1.31 |
| SAD Group I 10mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Volume. MAD Group | Change from BL at Day 8 | 0.32 fL | Standard Deviation 0.9 |
| SAD Group I 10mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Volume. MAD Group | Baseline (pre-dose Day 1) | 86.43 fL | Standard Deviation 1.29 |
| SAD Group I 10mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Volume. MAD Group | Change from BL at Day 3 | 0.55 fL | Standard Deviation 0.71 |
| SAD Group II 30mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Volume. MAD Group | Baseline (pre-dose Day 1) | 89.02 fL | Standard Deviation 2.93 |
| SAD Group II 30mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Volume. MAD Group | Change from BL at FU | 0.65 fL | Standard Deviation 0.77 |
| SAD Group II 30mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Volume. MAD Group | Change from BL at Day 8 | 0.28 fL | Standard Deviation 0.95 |
| SAD Group II 30mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Volume. MAD Group | Change from BL at Day 3 | 0.40 fL | Standard Deviation 1.08 |
Primary
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Volume - SAD
Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time frame: Baseline (pre-dose Day 1), 24 h post dose, FU (7 days after last dosing)
Population: The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group I Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Volume - SAD | Baseline (pre-dose Day 1) | 88.75 fL | Standard Deviation 5.36 |
| Group I Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Volume - SAD | Change from BL at FU | -1.10 fL | Standard Deviation 1.85 |
| Group I Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Volume - SAD | Change from BL at 24h | 0.45 fL | Standard Deviation 0.85 |
| Group II Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Volume - SAD | Change from BL at FU | -1.03 fL | Standard Deviation 0.46 |
| Group II Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Volume - SAD | Baseline (pre-dose Day 1) | 87.52 fL | Standard Deviation 3.71 |
| Group II Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Volume - SAD | Change from BL at 24h | -0.38 fL | Standard Deviation 1.09 |
| SAD Group I 10mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Volume - SAD | Baseline (pre-dose Day 1) | 90.15 fL | Standard Deviation 5.73 |
| SAD Group I 10mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Volume - SAD | Change from BL at FU | -1.68 fL | Standard Deviation 0.9 |
| SAD Group I 10mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Volume - SAD | Change from BL at 24h | 0.35 fL | Standard Deviation 0.37 |
| SAD Group II 30mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Volume - SAD | Baseline (pre-dose Day 1) | 88.35 fL | Standard Deviation 2.88 |
| SAD Group II 30mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Volume - SAD | Change from BL at 24h | 0.48 fL | Standard Deviation 0.41 |
| SAD Group II 30mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Volume - SAD | Change from BL at FU | -0.92 fL | Standard Deviation 1.28 |
| SAD Group I 100mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Volume - SAD | Change from BL at FU | -1.25 fL | Standard Deviation 1.54 |
| SAD Group I 100mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Volume - SAD | Change from BL at 24h | 0.00 fL | Standard Deviation 0.08 |
| SAD Group I 100mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Volume - SAD | Baseline (pre-dose Day 1) | 86.93 fL | Standard Deviation 4.75 |
| SAD Group II 300mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Volume - SAD | Change from BL at 24h | 0.85 fL | Standard Deviation 0.73 |
| SAD Group II 300mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Volume - SAD | Baseline (pre-dose Day 1) | 86.42 fL | Standard Deviation 2.83 |
| SAD Group II 300mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Volume - SAD | Change from BL at FU | -1.52 fL | Standard Deviation 0.69 |
| SAD Group I 800mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Volume - SAD | Baseline (pre-dose Day 1) | 88.55 fL | Standard Deviation 4.57 |
| SAD Group I 800mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Volume - SAD | Change from BL at FU | -1.45 fL | Standard Deviation 1.02 |
| SAD Group I 800mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Volume - SAD | Change from BL at 24h | -0.27 fL | Standard Deviation 0.21 |
| SAD Group II 2000mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Volume - SAD | Change from BL at FU | -2.30 fL | Standard Deviation 1 |
| SAD Group II 2000mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Volume - SAD | Change from BL at 24h | -1.33 fL | Standard Deviation 0.72 |
| SAD Group II 2000mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Volume - SAD | Baseline (pre-dose Day 1) | 89.73 fL | Standard Deviation 4.24 |
| Group I Placebo + Food | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Volume - SAD | Change from BL at FU | 1.10 fL | Standard Deviation 0.28 |
| Group I Placebo + Food | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Volume - SAD | Change from BL at 24h | 0.60 fL | Standard Deviation 0.28 |
| Group I Placebo + Food | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Volume - SAD | Baseline (pre-dose Day 1) | 87.10 fL | Standard Deviation 6.65 |
| Group I 100mg + Food | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Volume - SAD | Baseline (pre-dose Day 1) | 85.48 fL | Standard Deviation 4.36 |
| Group I 100mg + Food | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Volume - SAD | Change from BL at FU | 0.20 fL | Standard Deviation 0.81 |
| Group I 100mg + Food | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Volume - SAD | Change from BL at 24h | -0.55 fL | Standard Deviation 0.79 |
Primary
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Monocytes. MAD Group
Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time frame: Baseline (pre-dose Day 1), Day 3, Day 8, FU (7 days post dose)
Population: The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group I Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Monocytes. MAD Group | Change from BL at FU | -52.5 cells/µL | Standard Deviation 176.7 |
| Group I Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Monocytes. MAD Group | Baseline (pre-dose Day 1) | 505.0 cells/µL | Standard Deviation 44.3 |
| Group I Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Monocytes. MAD Group | Change from BL at Day 8 | 137.5 cells/µL | Standard Deviation 374.6 |
| Group I Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Monocytes. MAD Group | Change from BL at Day 3 | 75.0 cells/µL | Standard Deviation 151.5 |
| Group II Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Monocytes. MAD Group | Change from BL at Day 8 | 76.0 cells/µL | Standard Deviation 95.3 |
| Group II Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Monocytes. MAD Group | Change from BL at FU | -21.5 cells/µL | Standard Deviation 140.5 |
| Group II Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Monocytes. MAD Group | Change from BL at Day 3 | -11.5 cells/µL | Standard Deviation 142.6 |
| Group II Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Monocytes. MAD Group | Baseline (pre-dose Day 1) | 424.0 cells/µL | Standard Deviation 140.9 |
| SAD Group I 10mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Monocytes. MAD Group | Baseline (pre-dose Day 1) | 530.0 cells/µL | Standard Deviation 134.9 |
| SAD Group I 10mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Monocytes. MAD Group | Change from BL at Day 3 | 57.5 cells/µL | Standard Deviation 115 |
| SAD Group I 10mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Monocytes. MAD Group | Change from BL at Day 8 | 27.5 cells/µL | Standard Deviation 42.7 |
| SAD Group I 10mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Monocytes. MAD Group | Change from BL at FU | 82.5 cells/µL | Standard Deviation 76.8 |
| SAD Group II 30mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Monocytes. MAD Group | Change from BL at FU | -43.3 cells/µL | Standard Deviation 85 |
| SAD Group II 30mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Monocytes. MAD Group | Change from BL at Day 3 | 1.7 cells/µL | Standard Deviation 64.3 |
| SAD Group II 30mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Monocytes. MAD Group | Baseline (pre-dose Day 1) | 418.3 cells/µL | Standard Deviation 61.5 |
| SAD Group II 30mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Monocytes. MAD Group | Change from BL at Day 8 | 24.3 cells/µL | Standard Deviation 53.1 |
Primary
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Monocytes. SAD Group
Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time frame: Baseline (pre-dose Day 1), 24h post dose, FU (7 days post-dose)
Population: The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group I Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Monocytes. SAD Group | Change from BL at 24h | 1.7 cells/µL | Standard Deviation 46.7 |
| Group I Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Monocytes. SAD Group | Baseline (pre-dose Day 1) | 445.0 cells/µL | Standard Deviation 78.2 |
| Group I Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Monocytes. SAD Group | Change from BL at FU | -21.7 cells/µL | Standard Deviation 91.5 |
| Group II Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Monocytes. SAD Group | Baseline (pre-dose Day 1) | 496.7 cells/µL | Standard Deviation 71.7 |
| Group II Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Monocytes. SAD Group | Change from BL at 24h | -81.7 cells/µL | Standard Deviation 54.9 |
| Group II Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Monocytes. SAD Group | Change from BL at FU | -78.3 cells/µL | Standard Deviation 74.9 |
| SAD Group I 10mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Monocytes. SAD Group | Baseline (pre-dose Day 1) | 407.5 cells/µL | Standard Deviation 79.3 |
| SAD Group I 10mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Monocytes. SAD Group | Change from BL at FU | 30.0 cells/µL | Standard Deviation 136.4 |
| SAD Group I 10mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Monocytes. SAD Group | Change from BL at 24h | 20.0 cells/µL | Standard Deviation 78.3 |
| SAD Group II 30mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Monocytes. SAD Group | Baseline (pre-dose Day 1) | 455.0 cells/µL | Standard Deviation 81.9 |
| SAD Group II 30mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Monocytes. SAD Group | Change from BL at 24h | -45.0 cells/µL | Standard Deviation 19.3 |
| SAD Group II 30mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Monocytes. SAD Group | Change from BL at FU | -70.0 cells/µL | Standard Deviation 94.9 |
| SAD Group I 100mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Monocytes. SAD Group | Change from BL at 24h | 20.0 cells/µL | Standard Deviation 122.7 |
| SAD Group I 100mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Monocytes. SAD Group | Baseline (pre-dose Day 1) | 397.5 cells/µL | Standard Deviation 133 |
| SAD Group I 100mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Monocytes. SAD Group | Change from BL at FU | 5.0 cells/µL | Standard Deviation 128.2 |
| SAD Group II 300mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Monocytes. SAD Group | Change from BL at 24h | -62.5 cells/µL | Standard Deviation 185.5 |
| SAD Group II 300mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Monocytes. SAD Group | Baseline (pre-dose Day 1) | 467.5 cells/µL | Standard Deviation 98.8 |
| SAD Group II 300mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Monocytes. SAD Group | Change from BL at FU | -42.5 cells/µL | Standard Deviation 86.6 |
| SAD Group I 800mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Monocytes. SAD Group | Change from BL at 24h | -25.0 cells/µL | Standard Deviation 112.4 |
| SAD Group I 800mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Monocytes. SAD Group | Change from BL at FU | 0.0 cells/µL | Standard Deviation 94.9 |
| SAD Group I 800mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Monocytes. SAD Group | Baseline (pre-dose Day 1) | 462.5 cells/µL | Standard Deviation 147.1 |
| SAD Group II 2000mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Monocytes. SAD Group | Baseline (pre-dose Day 1) | 470.0 cells/µL | Standard Deviation 87.6 |
| SAD Group II 2000mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Monocytes. SAD Group | Change from BL at 24h | 2.5 cells/µL | Standard Deviation 56.8 |
| SAD Group II 2000mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Monocytes. SAD Group | Change from BL at FU | -47.5 cells/µL | Standard Deviation 63.4 |
| Group I Placebo + Food | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Monocytes. SAD Group | Change from BL at FU | -20.0 cells/µL | Standard Deviation 127.3 |
| Group I Placebo + Food | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Monocytes. SAD Group | Change from BL at 24h | -45.0 cells/µL | Standard Deviation 21.2 |
| Group I Placebo + Food | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Monocytes. SAD Group | Baseline (pre-dose Day 1) | 550.0 cells/µL | Standard Deviation 70.7 |
| Group I 100mg + Food | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Monocytes. SAD Group | Change from BL at FU | -110.0 cells/µL | Standard Deviation 128.3 |
| Group I 100mg + Food | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Monocytes. SAD Group | Change from BL at 24h | -55.0 cells/µL | Standard Deviation 70.5 |
| Group I 100mg + Food | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Monocytes. SAD Group | Baseline (pre-dose Day 1) | 512.5 cells/µL | Standard Deviation 133.5 |
Primary
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Neutrophils. MAD Group
Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time frame: Baseline (pre-dose Day 1), Day 3, Day 8, FU (7 days post dose)
Population: The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group I Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Neutrophils. MAD Group | Change from BL at Day 3 | -567.5 cells/µL | Standard Deviation 667.9 |
| Group I Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Neutrophils. MAD Group | Change from BL at FU | 185.0 cells/µL | Standard Deviation 2317.4 |
| Group I Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Neutrophils. MAD Group | Baseline (pre-dose Day 1) | 3077.5 cells/µL | Standard Deviation 569.5 |
| Group I Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Neutrophils. MAD Group | Change from BL at Day 8 | 105.0 cells/µL | Standard Deviation 2079.7 |
| Group II Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Neutrophils. MAD Group | Change from BL at Day 8 | 312.5 cells/µL | Standard Deviation 355.1 |
| Group II Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Neutrophils. MAD Group | Baseline (pre-dose Day 1) | 2602.5 cells/µL | Standard Deviation 582.4 |
| Group II Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Neutrophils. MAD Group | Change from BL at FU | 177.5 cells/µL | Standard Deviation 827.7 |
| Group II Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Neutrophils. MAD Group | Change from BL at Day 3 | 350.0 cells/µL | Standard Deviation 602.4 |
| SAD Group I 10mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Neutrophils. MAD Group | Change from BL at FU | 1010.0 cells/µL | Standard Deviation 622.7 |
| SAD Group I 10mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Neutrophils. MAD Group | Baseline (pre-dose Day 1) | 2935.0 cells/µL | Standard Deviation 966.6 |
| SAD Group I 10mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Neutrophils. MAD Group | Change from BL at Day 8 | 537.5 cells/µL | Standard Deviation 174.6 |
| SAD Group I 10mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Neutrophils. MAD Group | Change from BL at Day 3 | 437.5 cells/µL | Standard Deviation 505.3 |
| SAD Group II 30mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Neutrophils. MAD Group | Change from BL at FU | -75.0 cells/µL | Standard Deviation 532.1 |
| SAD Group II 30mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Neutrophils. MAD Group | Change from BL at Day 3 | 81.7 cells/µL | Standard Deviation 540.7 |
| SAD Group II 30mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Neutrophils. MAD Group | Baseline (pre-dose Day 1) | 2483.3 cells/µL | Standard Deviation 583.6 |
| SAD Group II 30mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Neutrophils. MAD Group | Change from BL at Day 8 | 261.0 cells/µL | Standard Deviation 634.9 |
Primary
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Neutrophils. SAD Group
Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time frame: Baseline (pre-dose Day 1), 24h post dose, FU (7 days after last dosing)
Population: The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group I Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Neutrophils. SAD Group | Change from BL at FU | 205.0 cells/µL | Standard Deviation 161.8 |
| Group I Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Neutrophils. SAD Group | Change from BL at 24h | 356.7 cells/µL | Standard Deviation 336.9 |
| Group I Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Neutrophils. SAD Group | Baseline (pre-dose Day 1) | 2276.7 cells/µL | Standard Deviation 551.2 |
| Group II Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Neutrophils. SAD Group | Change from BL at FU | -16.7 cells/µL | Standard Deviation 335.4 |
| Group II Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Neutrophils. SAD Group | Baseline (pre-dose Day 1) | 2296.7 cells/µL | Standard Deviation 658.7 |
| Group II Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Neutrophils. SAD Group | Change from BL at 24h | 98.3 cells/µL | Standard Deviation 171.2 |
| SAD Group I 10mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Neutrophils. SAD Group | Baseline (pre-dose Day 1) | 2117.5 cells/µL | Standard Deviation 369.2 |
| SAD Group I 10mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Neutrophils. SAD Group | Change from BL at FU | 90.0 cells/µL | Standard Deviation 183.5 |
| SAD Group I 10mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Neutrophils. SAD Group | Change from BL at 24h | 7.5 cells/µL | Standard Deviation 196.7 |
| SAD Group II 30mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Neutrophils. SAD Group | Change from BL at FU | 107.5 cells/µL | Standard Deviation 252.1 |
| SAD Group II 30mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Neutrophils. SAD Group | Baseline (pre-dose Day 1) | 2365.0 cells/µL | Standard Deviation 820.8 |
| SAD Group II 30mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Neutrophils. SAD Group | Change from BL at 24h | 410.0 cells/µL | Standard Deviation 593 |
| SAD Group I 100mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Neutrophils. SAD Group | Change from BL at 24h | 272.5 cells/µL | Standard Deviation 419.1 |
| SAD Group I 100mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Neutrophils. SAD Group | Baseline (pre-dose Day 1) | 2380.0 cells/µL | Standard Deviation 679 |
| SAD Group I 100mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Neutrophils. SAD Group | Change from BL at FU | 255.0 cells/µL | Standard Deviation 519 |
| SAD Group II 300mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Neutrophils. SAD Group | Change from BL at FU | -167.5 cells/µL | Standard Deviation 480.7 |
| SAD Group II 300mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Neutrophils. SAD Group | Change from BL at 24h | 165.0 cells/µL | Standard Deviation 335.5 |
| SAD Group II 300mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Neutrophils. SAD Group | Baseline (pre-dose Day 1) | 2197.5 cells/µL | Standard Deviation 835.9 |
| SAD Group I 800mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Neutrophils. SAD Group | Change from BL at 24h | 285.0 cells/µL | Standard Deviation 155 |
| SAD Group I 800mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Neutrophils. SAD Group | Change from BL at FU | -12.5 cells/µL | Standard Deviation 203.5 |
| SAD Group I 800mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Neutrophils. SAD Group | Baseline (pre-dose Day 1) | 2565.0 cells/µL | Standard Deviation 462.6 |
| SAD Group II 2000mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Neutrophils. SAD Group | Baseline (pre-dose Day 1) | 2360.0 cells/µL | Standard Deviation 438.1 |
| SAD Group II 2000mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Neutrophils. SAD Group | Change from BL at FU | -382.5 cells/µL | Standard Deviation 232.9 |
| SAD Group II 2000mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Neutrophils. SAD Group | Change from BL at 24h | 440.0 cells/µL | Standard Deviation 601.5 |
| Group I Placebo + Food | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Neutrophils. SAD Group | Change from BL at FU | -205.0 cells/µL | Standard Deviation 445.5 |
| Group I Placebo + Food | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Neutrophils. SAD Group | Change from BL at 24h | 445.0 cells/µL | Standard Deviation 459.6 |
| Group I Placebo + Food | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Neutrophils. SAD Group | Baseline (pre-dose Day 1) | 2280.0 cells/µL | Standard Deviation 169.7 |
| Group I 100mg + Food | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Neutrophils. SAD Group | Change from BL at 24h | -122.5 cells/µL | Standard Deviation 584.3 |
| Group I 100mg + Food | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Neutrophils. SAD Group | Change from BL at FU | -557.5 cells/µL | Standard Deviation 1326.2 |
| Group I 100mg + Food | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Neutrophils. SAD Group | Baseline (pre-dose Day 1) | 3192.5 cells/µL | Standard Deviation 1523.9 |
Primary
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Red Blood Cell Count. MAD Group
Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time frame: Baseline (pre-dose Day 1), Day 3, Day 8, FU (7 days post dose)
Population: The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group I Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Red Blood Cell Count. MAD Group | Change from BL at Day 3 | 0.313 cells 10^6/µL | Standard Deviation 0.234 |
| Group I Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Red Blood Cell Count. MAD Group | Baseline (pre-dose Day 1) | 4.588 cells 10^6/µL | Standard Deviation 0.108 |
| Group I Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Red Blood Cell Count. MAD Group | Change from BL at FU | 0.075 cells 10^6/µL | Standard Deviation 0.099 |
| Group I Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Red Blood Cell Count. MAD Group | Change from BL at Day 8 | 0.385 cells 10^6/µL | Standard Deviation 0.139 |
| Group II Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Red Blood Cell Count. MAD Group | Change from BL at FU | 0.020 cells 10^6/µL | Standard Deviation 0.35 |
| Group II Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Red Blood Cell Count. MAD Group | Baseline (pre-dose Day 1) | 4.858 cells 10^6/µL | Standard Deviation 0.38 |
| Group II Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Red Blood Cell Count. MAD Group | Change from BL at Day 8 | 0.160 cells 10^6/µL | Standard Deviation 0.362 |
| Group II Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Red Blood Cell Count. MAD Group | Change from BL at Day 3 | 0.100 cells 10^6/µL | Standard Deviation 0.193 |
| SAD Group I 10mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Red Blood Cell Count. MAD Group | Change from BL at FU | -0.192 cells 10^6/µL | Standard Deviation 0.145 |
| SAD Group I 10mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Red Blood Cell Count. MAD Group | Baseline (pre-dose Day 1) | 5.217 cells 10^6/µL | Standard Deviation 0.138 |
| SAD Group I 10mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Red Blood Cell Count. MAD Group | Change from BL at Day 3 | -0.017 cells 10^6/µL | Standard Deviation 0.06 |
| SAD Group I 10mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Red Blood Cell Count. MAD Group | Change from BL at Day 8 | -0.007 cells 10^6/µL | Standard Deviation 0.144 |
| SAD Group II 30mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Red Blood Cell Count. MAD Group | Change from BL at Day 8 | 0.198 cells 10^6/µL | Standard Deviation 0.249 |
| SAD Group II 30mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Red Blood Cell Count. MAD Group | Change from BL at FU | -0.120 cells 10^6/µL | Standard Deviation 0.237 |
| SAD Group II 30mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Red Blood Cell Count. MAD Group | Baseline (pre-dose Day 1) | 4.873 cells 10^6/µL | Standard Deviation 0.36 |
| SAD Group II 30mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Red Blood Cell Count. MAD Group | Change from BL at Day 3 | 0.167 cells 10^6/µL | Standard Deviation 0.196 |
Primary
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Red Blood Cell Count. SAD Group
Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time frame: Baseline (pre-dose Day 1), 24h post dose, FU (7 days after last dosing)
Population: The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group I Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Red Blood Cell Count. SAD Group | Baseline (pre-dose Day 1) | 4.947 cells 10^6/µL | Standard Deviation 0.488 |
| Group I Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Red Blood Cell Count. SAD Group | Change from BL at 24h | 0.200 cells 10^6/µL | Standard Deviation 0.495 |
| Group I Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Red Blood Cell Count. SAD Group | Change from BL at FU | 0.003 cells 10^6/µL | Standard Deviation 0.215 |
| Group II Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Red Blood Cell Count. SAD Group | Change from BL at 24h | 0.095 cells 10^6/µL | Standard Deviation 0.26 |
| Group II Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Red Blood Cell Count. SAD Group | Baseline (pre-dose Day 1) | 4.933 cells 10^6/µL | Standard Deviation 0.307 |
| Group II Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Red Blood Cell Count. SAD Group | Change from BL at FU | -0.013 cells 10^6/µL | Standard Deviation 0.149 |
| SAD Group I 10mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Red Blood Cell Count. SAD Group | Baseline (pre-dose Day 1) | 4.793 cells 10^6/µL | Standard Deviation 0.455 |
| SAD Group I 10mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Red Blood Cell Count. SAD Group | Change from BL at 24h | 0.063 cells 10^6/µL | Standard Deviation 0.085 |
| SAD Group I 10mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Red Blood Cell Count. SAD Group | Change from BL at FU | 0.185 cells 10^6/µL | Standard Deviation 0.104 |
| SAD Group II 30mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Red Blood Cell Count. SAD Group | Change from BL at 24h | 0.188 cells 10^6/µL | Standard Deviation 0.153 |
| SAD Group II 30mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Red Blood Cell Count. SAD Group | Baseline (pre-dose Day 1) | 5.030 cells 10^6/µL | Standard Deviation 0.458 |
| SAD Group II 30mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Red Blood Cell Count. SAD Group | Change from BL at FU | -0.052 cells 10^6/µL | Standard Deviation 0.183 |
| SAD Group I 100mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Red Blood Cell Count. SAD Group | Baseline (pre-dose Day 1) | 4.953 cells 10^6/µL | Standard Deviation 0.247 |
| SAD Group I 100mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Red Blood Cell Count. SAD Group | Change from BL at FU | 0.083 cells 10^6/µL | Standard Deviation 0.127 |
| SAD Group I 100mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Red Blood Cell Count. SAD Group | Change from BL at 24h | 0.170 cells 10^6/µL | Standard Deviation 0.25 |
| SAD Group II 300mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Red Blood Cell Count. SAD Group | Baseline (pre-dose Day 1) | 5.137 cells 10^6/µL | Standard Deviation 0.393 |
| SAD Group II 300mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Red Blood Cell Count. SAD Group | Change from BL at FU | -0.147 cells 10^6/µL | Standard Deviation 0.041 |
| SAD Group II 300mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Red Blood Cell Count. SAD Group | Change from BL at 24h | 0.065 cells 10^6/µL | Standard Deviation 0.197 |
| SAD Group I 800mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Red Blood Cell Count. SAD Group | Change from BL at FU | -0.053 cells 10^6/µL | Standard Deviation 0.209 |
| SAD Group I 800mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Red Blood Cell Count. SAD Group | Change from BL at 24h | 0.173 cells 10^6/µL | Standard Deviation 0.2 |
| SAD Group I 800mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Red Blood Cell Count. SAD Group | Baseline (pre-dose Day 1) | 4.973 cells 10^6/µL | Standard Deviation 0.141 |
| SAD Group II 2000mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Red Blood Cell Count. SAD Group | Change from BL at 24h | 0.325 cells 10^6/µL | Standard Deviation 0.185 |
| SAD Group II 2000mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Red Blood Cell Count. SAD Group | Baseline (pre-dose Day 1) | 4.623 cells 10^6/µL | Standard Deviation 0.395 |
| SAD Group II 2000mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Red Blood Cell Count. SAD Group | Change from BL at FU | 0.125 cells 10^6/µL | Standard Deviation 0.182 |
| Group I Placebo + Food | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Red Blood Cell Count. SAD Group | Baseline (pre-dose Day 1) | 5.095 cells 10^6/µL | Standard Deviation 0.12 |
| Group I Placebo + Food | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Red Blood Cell Count. SAD Group | Change from BL at FU | -0.150 cells 10^6/µL | Standard Deviation 0.339 |
| Group I Placebo + Food | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Red Blood Cell Count. SAD Group | Change from BL at 24h | 0.185 cells 10^6/µL | Standard Deviation 0.064 |
| Group I 100mg + Food | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Red Blood Cell Count. SAD Group | Change from BL at 24h | 0.115 cells 10^6/µL | Standard Deviation 0.208 |
| Group I 100mg + Food | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Red Blood Cell Count. SAD Group | Change from BL at FU | 0.050 cells 10^6/µL | Standard Deviation 0.211 |
| Group I 100mg + Food | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Red Blood Cell Count. SAD Group | Baseline (pre-dose Day 1) | 4.985 cells 10^6/µL | Standard Deviation 0.343 |
Primary
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Thrombocytes. MAD Group
Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time frame: Baseline (pre-dose Day 1), Day 3, Day 8, FU (7 days post dose)
Population: The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group I Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Thrombocytes. MAD Group | Change from BL at Day 3 | 15.5 cells 10^3/µL | Standard Deviation 14.5 |
| Group I Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Thrombocytes. MAD Group | Change from BL at FU | 63.8 cells 10^3/µL | Standard Deviation 41.3 |
| Group I Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Thrombocytes. MAD Group | Change from BL at Day 8 | 44.8 cells 10^3/µL | Standard Deviation 37.6 |
| Group I Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Thrombocytes. MAD Group | Baseline (pre-dose Day 1) | 207.3 cells 10^3/µL | Standard Deviation 24.6 |
| Group II Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Thrombocytes. MAD Group | Change from BL at Day 3 | 17.5 cells 10^3/µL | Standard Deviation 9.5 |
| Group II Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Thrombocytes. MAD Group | Change from BL at Day 8 | 4.8 cells 10^3/µL | Standard Deviation 22.3 |
| Group II Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Thrombocytes. MAD Group | Change from BL at FU | 5.5 cells 10^3/µL | Standard Deviation 21.9 |
| Group II Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Thrombocytes. MAD Group | Baseline (pre-dose Day 1) | 211.5 cells 10^3/µL | Standard Deviation 41.2 |
| SAD Group I 10mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Thrombocytes. MAD Group | Change from BL at Day 3 | 27.5 cells 10^3/µL | Standard Deviation 8.4 |
| SAD Group I 10mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Thrombocytes. MAD Group | Change from BL at Day 8 | 31.3 cells 10^3/µL | Standard Deviation 13.9 |
| SAD Group I 10mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Thrombocytes. MAD Group | Baseline (pre-dose Day 1) | 199.8 cells 10^3/µL | Standard Deviation 25.6 |
| SAD Group I 10mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Thrombocytes. MAD Group | Change from BL at FU | 33.8 cells 10^3/µL | Standard Deviation 20 |
| SAD Group II 30mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Thrombocytes. MAD Group | Change from BL at FU | 21.7 cells 10^3/µL | Standard Deviation 10.7 |
| SAD Group II 30mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Thrombocytes. MAD Group | Change from BL at Day 8 | 29.5 cells 10^3/µL | Standard Deviation 12.5 |
| SAD Group II 30mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Thrombocytes. MAD Group | Change from BL at Day 3 | 17.3 cells 10^3/µL | Standard Deviation 15.1 |
| SAD Group II 30mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Thrombocytes. MAD Group | Baseline (pre-dose Day 1) | 206.7 cells 10^3/µL | Standard Deviation 48.1 |
Primary
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Thrombocytes. SAD Group
Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time frame: Baseline (pre-dose Day 1), 24h, FU (7 days post-dose)
Population: The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group I Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Thrombocytes. SAD Group | Change from BL at FU | 11.8 cells 10^3/µL | Standard Deviation 14 |
| Group I Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Thrombocytes. SAD Group | Change from BL at 24h | 0.0 cells 10^3/µL | Standard Deviation 9.7 |
| Group I Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Thrombocytes. SAD Group | Baseline (pre-dose Day 1) | 209.5 cells 10^3/µL | Standard Deviation 45.9 |
| Group II Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Thrombocytes. SAD Group | Change from BL at FU | 22.5 cells 10^3/µL | Standard Deviation 15.7 |
| Group II Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Thrombocytes. SAD Group | Baseline (pre-dose Day 1) | 204.0 cells 10^3/µL | Standard Deviation 15.7 |
| Group II Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Thrombocytes. SAD Group | Change from BL at 24h | 4.8 cells 10^3/µL | Standard Deviation 6.1 |
| SAD Group I 10mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Thrombocytes. SAD Group | Baseline (pre-dose Day 1) | 193.0 cells 10^3/µL | Standard Deviation 31.9 |
| SAD Group I 10mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Thrombocytes. SAD Group | Change from BL at FU | 23.8 cells 10^3/µL | Standard Deviation 7.4 |
| SAD Group I 10mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Thrombocytes. SAD Group | Change from BL at 24h | 8.5 cells 10^3/µL | Standard Deviation 12.4 |
| SAD Group II 30mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Thrombocytes. SAD Group | Change from BL at FU | 8.5 cells 10^3/µL | Standard Deviation 24.3 |
| SAD Group II 30mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Thrombocytes. SAD Group | Baseline (pre-dose Day 1) | 223.0 cells 10^3/µL | Standard Deviation 21.6 |
| SAD Group II 30mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Thrombocytes. SAD Group | Change from BL at 24h | 2.3 cells 10^3/µL | Standard Deviation 12.8 |
| SAD Group I 100mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Thrombocytes. SAD Group | Change from BL at 24h | 3.8 cells 10^3/µL | Standard Deviation 20.3 |
| SAD Group I 100mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Thrombocytes. SAD Group | Change from BL at FU | 16.3 cells 10^3/µL | Standard Deviation 14.5 |
| SAD Group I 100mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Thrombocytes. SAD Group | Baseline (pre-dose Day 1) | 215.8 cells 10^3/µL | Standard Deviation 64 |
| SAD Group II 300mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Thrombocytes. SAD Group | Baseline (pre-dose Day 1) | 203.8 cells 10^3/µL | Standard Deviation 7 |
| SAD Group II 300mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Thrombocytes. SAD Group | Change from BL at 24h | -14.5 cells 10^3/µL | Standard Deviation 29.7 |
| SAD Group II 300mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Thrombocytes. SAD Group | Change from BL at FU | 7.3 cells 10^3/µL | Standard Deviation 7.9 |
| SAD Group I 800mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Thrombocytes. SAD Group | Baseline (pre-dose Day 1) | 202.3 cells 10^3/µL | Standard Deviation 54.5 |
| SAD Group I 800mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Thrombocytes. SAD Group | Change from BL at 24h | 22.3 cells 10^3/µL | Standard Deviation 13.5 |
| SAD Group I 800mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Thrombocytes. SAD Group | Change from BL at FU | 15.8 cells 10^3/µL | Standard Deviation 14.3 |
| SAD Group II 2000mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Thrombocytes. SAD Group | Change from BL at FU | 21.5 cells 10^3/µL | Standard Deviation 22.4 |
| SAD Group II 2000mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Thrombocytes. SAD Group | Baseline (pre-dose Day 1) | 160.1 cells 10^3/µL | Standard Deviation 100.8 |
| SAD Group II 2000mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Thrombocytes. SAD Group | Change from BL at 24h | 23.0 cells 10^3/µL | Standard Deviation 22.8 |
| Group I Placebo + Food | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Thrombocytes. SAD Group | Change from BL at FU | 1.0 cells 10^3/µL | Standard Deviation 15.6 |
| Group I Placebo + Food | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Thrombocytes. SAD Group | Change from BL at 24h | 4.0 cells 10^3/µL | Standard Deviation 7.1 |
| Group I Placebo + Food | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Thrombocytes. SAD Group | Baseline (pre-dose Day 1) | 204.5 cells 10^3/µL | Standard Deviation 67.2 |
| Group I 100mg + Food | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Thrombocytes. SAD Group | Change from BL at FU | 16.3 cells 10^3/µL | Standard Deviation 12.5 |
| Group I 100mg + Food | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Thrombocytes. SAD Group | Change from BL at 24h | 0.3 cells 10^3/µL | Standard Deviation 9 |
| Group I 100mg + Food | Change From Baseline in Hematology Laboratory Test Results by Timepoint: Thrombocytes. SAD Group | Baseline (pre-dose Day 1) | 215.8 cells 10^3/µL | Standard Deviation 55.6 |
Primary
Change From Baseline in Hematology Laboratory Test Results by Timepoint: White Blood Cell Count. MAD
Blood samples were collected from participants at the indicated time points for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each time point are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time frame: Baseline (pre-dose Day 1), Day 3, Day 8, FU (7 days post dose)
Population: The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group I Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: White Blood Cell Count. MAD | Baseline (pre-dose Day 1) | 5.463 cells 10^3/µL | Standard Deviation 0.579 |
| Group I Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: White Blood Cell Count. MAD | Change from BL at Day 3 | -0.435 cells 10^3/µL | Standard Deviation 0.631 |
| Group I Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: White Blood Cell Count. MAD | Change from BL at FU | 0.060 cells 10^3/µL | Standard Deviation 2.519 |
| Group I Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: White Blood Cell Count. MAD | Change from BL at Day 8 | 0.223 cells 10^3/µL | Standard Deviation 2.237 |
| Group II Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: White Blood Cell Count. MAD | Change from BL at FU | 0.230 cells 10^3/µL | Standard Deviation 0.87 |
| Group II Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: White Blood Cell Count. MAD | Change from BL at Day 3 | 0.480 cells 10^3/µL | Standard Deviation 0.787 |
| Group II Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: White Blood Cell Count. MAD | Change from BL at Day 8 | 0.480 cells 10^3/µL | Standard Deviation 0.252 |
| Group II Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: White Blood Cell Count. MAD | Baseline (pre-dose Day 1) | 4.753 cells 10^3/µL | Standard Deviation 0.41 |
| SAD Group I 10mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: White Blood Cell Count. MAD | Change from BL at FU | 1.340 cells 10^3/µL | Standard Deviation 0.546 |
| SAD Group I 10mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: White Blood Cell Count. MAD | Baseline (pre-dose Day 1) | 5.378 cells 10^3/µL | Standard Deviation 1.221 |
| SAD Group I 10mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: White Blood Cell Count. MAD | Change from BL at Day 3 | 0.895 cells 10^3/µL | Standard Deviation 0.94 |
| SAD Group I 10mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: White Blood Cell Count. MAD | Change from BL at Day 8 | 0.795 cells 10^3/µL | Standard Deviation 0.178 |
| SAD Group II 30mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: White Blood Cell Count. MAD | Change from BL at Day 8 | 0.563 cells 10^3/µL | Standard Deviation 0.983 |
| SAD Group II 30mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: White Blood Cell Count. MAD | Change from BL at FU | -0.140 cells 10^3/µL | Standard Deviation 0.93 |
| SAD Group II 30mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: White Blood Cell Count. MAD | Change from BL at Day 3 | 0.277 cells 10^3/µL | Standard Deviation 0.932 |
| SAD Group II 30mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: White Blood Cell Count. MAD | Baseline (pre-dose Day 1) | 4.583 cells 10^3/µL | Standard Deviation 0.487 |
Primary
Change From Baseline in Hematology Laboratory Test Results by Timepoint: White Blood Cell Count. SAD Group
Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time frame: Baseline (pre-dose Day 1), 24h post dose, FU (7 days after last dosing)
Population: The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group I Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: White Blood Cell Count. SAD Group | Change from BL at FU | 0.258 cells 10^3/µL | Standard Deviation 0.309 |
| Group I Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: White Blood Cell Count. SAD Group | Change from BL at 24h | 0.343 cells 10^3/µL | Standard Deviation 0.525 |
| Group I Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: White Blood Cell Count. SAD Group | Baseline (pre-dose Day 1) | 4.435 cells 10^3/µL | Standard Deviation 0.526 |
| Group II Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: White Blood Cell Count. SAD Group | Change from BL at FU | -0.203 cells 10^3/µL | Standard Deviation 0.662 |
| Group II Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: White Blood Cell Count. SAD Group | Baseline (pre-dose Day 1) | 4.773 cells 10^3/µL | Standard Deviation 0.548 |
| Group II Placebo | Change From Baseline in Hematology Laboratory Test Results by Timepoint: White Blood Cell Count. SAD Group | Change from BL at 24h | -0.057 cells 10^3/µL | Standard Deviation 0.359 |
| SAD Group I 10mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: White Blood Cell Count. SAD Group | Baseline (pre-dose Day 1) | 4.313 cells 10^3/µL | Standard Deviation 0.418 |
| SAD Group I 10mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: White Blood Cell Count. SAD Group | Change from BL at 24h | -0.033 cells 10^3/µL | Standard Deviation 0.317 |
| SAD Group I 10mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: White Blood Cell Count. SAD Group | Change from BL at FU | 0.288 cells 10^3/µL | Standard Deviation 0.211 |
| SAD Group II 30mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: White Blood Cell Count. SAD Group | Change from BL at FU | -0.073 cells 10^3/µL | Standard Deviation 0.367 |
| SAD Group II 30mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: White Blood Cell Count. SAD Group | Baseline (pre-dose Day 1) | 4.863 cells 10^3/µL | Standard Deviation 0.372 |
| SAD Group II 30mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: White Blood Cell Count. SAD Group | Change from BL at 24h | 0.160 cells 10^3/µL | Standard Deviation 0.329 |
| SAD Group I 100mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: White Blood Cell Count. SAD Group | Change from BL at 24h | 0.257 cells 10^3/µL | Standard Deviation 0.529 |
| SAD Group I 100mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: White Blood Cell Count. SAD Group | Change from BL at FU | 0.395 cells 10^3/µL | Standard Deviation 0.617 |
| SAD Group I 100mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: White Blood Cell Count. SAD Group | Baseline (pre-dose Day 1) | 4.395 cells 10^3/µL | Standard Deviation 0.694 |
| SAD Group II 300mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: White Blood Cell Count. SAD Group | Change from BL at 24h | 0.160 cells 10^3/µL | Standard Deviation 0.753 |
| SAD Group II 300mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: White Blood Cell Count. SAD Group | Change from BL at FU | -0.287 cells 10^3/µL | Standard Deviation 0.618 |
| SAD Group II 300mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: White Blood Cell Count. SAD Group | Baseline (pre-dose Day 1) | 4.475 cells 10^3/µL | Standard Deviation 0.733 |
| SAD Group I 800mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: White Blood Cell Count. SAD Group | Change from BL at FU | 0.215 cells 10^3/µL | Standard Deviation 0.266 |
| SAD Group I 800mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: White Blood Cell Count. SAD Group | Change from BL at 24h | 0.528 cells 10^3/µL | Standard Deviation 0.324 |
| SAD Group I 800mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: White Blood Cell Count. SAD Group | Baseline (pre-dose Day 1) | 4.853 cells 10^3/µL | Standard Deviation 0.372 |
| SAD Group II 2000mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: White Blood Cell Count. SAD Group | Baseline (pre-dose Day 1) | 5.118 cells 10^3/µL | Standard Deviation 0.647 |
| SAD Group II 2000mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: White Blood Cell Count. SAD Group | Change from BL at FU | -0.320 cells 10^3/µL | Standard Deviation 0.592 |
| SAD Group II 2000mg | Change From Baseline in Hematology Laboratory Test Results by Timepoint: White Blood Cell Count. SAD Group | Change from BL at 24h | 0.655 cells 10^3/µL | Standard Deviation 0.666 |
| Group I Placebo + Food | Change From Baseline in Hematology Laboratory Test Results by Timepoint: White Blood Cell Count. SAD Group | Change from BL at 24h | 0.220 cells 10^3/µL | Standard Deviation 0.721 |
| Group I Placebo + Food | Change From Baseline in Hematology Laboratory Test Results by Timepoint: White Blood Cell Count. SAD Group | Baseline (pre-dose Day 1) | 5.815 cells 10^3/µL | Standard Deviation 2.072 |
| Group I Placebo + Food | Change From Baseline in Hematology Laboratory Test Results by Timepoint: White Blood Cell Count. SAD Group | Change from BL at FU | -0.560 cells 10^3/µL | Standard Deviation 1.202 |
| Group I 100mg + Food | Change From Baseline in Hematology Laboratory Test Results by Timepoint: White Blood Cell Count. SAD Group | Change from BL at FU | -0.745 cells 10^3/µL | Standard Deviation 1.535 |
| Group I 100mg + Food | Change From Baseline in Hematology Laboratory Test Results by Timepoint: White Blood Cell Count. SAD Group | Baseline (pre-dose Day 1) | 5.535 cells 10^3/µL | Standard Deviation 1.467 |
| Group I 100mg + Food | Change From Baseline in Hematology Laboratory Test Results by Timepoint: White Blood Cell Count. SAD Group | Change from BL at 24h | -0.280 cells 10^3/µL | Standard Deviation 0.555 |
Primary
KH173 + KH183: Percentage of Administered Dose Excreted in Urine: MAD
Urine concentrations of KH176 and KH183 were analysed after multiple-dose administration of doses of 100, 200 and 400 mg b.i.d.
Time frame: Day 7 Post dose
Population: Per protocol set. The placebo subjects were excluded from the Pharmacokinetics (PK) analysis per-protocol set.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Group I Placebo | KH173 + KH183: Percentage of Administered Dose Excreted in Urine: MAD | 20.7 percentage of dose excreted | Geometric Coefficient of Variation 79.3 |
| Group II Placebo | KH173 + KH183: Percentage of Administered Dose Excreted in Urine: MAD | 17.4 percentage of dose excreted | Geometric Coefficient of Variation 33.3 |
| SAD Group I 10mg | KH173 + KH183: Percentage of Administered Dose Excreted in Urine: MAD | 19.0 percentage of dose excreted | Geometric Coefficient of Variation 17.9 |
Primary
KH176 + KH183: Percentage of Administered Dose Excreted in Urine: SAD
Urine concentrations of KH176 were analysed after single dose administration of doses 10mg, 30mg, 100mg (with and without food), 300mg, 800mg, 2000mg b.i.d.
Time frame: 24 hours post-dose
Population: Per protocol set
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Group I Placebo | KH176 + KH183: Percentage of Administered Dose Excreted in Urine: SAD | 14.4 percentage of dose excreted | Geometric Coefficient of Variation 40 |
| Group II Placebo | KH176 + KH183: Percentage of Administered Dose Excreted in Urine: SAD | 17.2 percentage of dose excreted | Geometric Coefficient of Variation 28.6 |
| SAD Group I 10mg | KH176 + KH183: Percentage of Administered Dose Excreted in Urine: SAD | 15.8 percentage of dose excreted | Geometric Coefficient of Variation 24.5 |
| SAD Group II 30mg | KH176 + KH183: Percentage of Administered Dose Excreted in Urine: SAD | 13.4 percentage of dose excreted | Geometric Coefficient of Variation 69.9 |
| SAD Group I 100mg | KH176 + KH183: Percentage of Administered Dose Excreted in Urine: SAD | 14.8 percentage of dose excreted | Geometric Coefficient of Variation 38.4 |
| SAD Group II 300mg | KH176 + KH183: Percentage of Administered Dose Excreted in Urine: SAD | 15.9 percentage of dose excreted | Geometric Coefficient of Variation 16.4 |
Primary
KH176: Percentage of Administered Dose Excreted in Urine: MAD
Urine concentrations of KH176 were analysed after multiple-dose administration of doses of 100, 200 and 400 mg b.i.d.
Time frame: Day 7 post dose
Population: Per protocol set. The placebo subjects were excluded from the Pharmacokinetics (PK) analysis per-protocol set.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Group I Placebo | KH176: Percentage of Administered Dose Excreted in Urine: MAD | 14.9 percentage of dose excreted | Geometric Coefficient of Variation 77.8 |
| Group II Placebo | KH176: Percentage of Administered Dose Excreted in Urine: MAD | 13.4 percentage of dose excreted | Geometric Coefficient of Variation 36.4 |
| SAD Group I 10mg | KH176: Percentage of Administered Dose Excreted in Urine: MAD | 14.0 percentage of dose excreted | Geometric Coefficient of Variation 14.5 |
Primary
KH176: Percentage of Administered Dose Excreted in Urine: SAD
Urine concentrations of KH176 were analysed after single dose administration of doses 10mg, 30mg, 100mg (with and without food), 300mg, 800mg, 2000mg b.i.d.
Time frame: 24 hours post-dose
Population: Per protocol set
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Group I Placebo | KH176: Percentage of Administered Dose Excreted in Urine: SAD | 9.71 percentage of dose excreted | Geometric Coefficient of Variation 37.4 |
| Group II Placebo | KH176: Percentage of Administered Dose Excreted in Urine: SAD | 10.5 percentage of dose excreted | Geometric Coefficient of Variation 45.6 |
| SAD Group I 10mg | KH176: Percentage of Administered Dose Excreted in Urine: SAD | 10.4 percentage of dose excreted | Geometric Coefficient of Variation 29.5 |
| SAD Group II 30mg | KH176: Percentage of Administered Dose Excreted in Urine: SAD | 9.53 percentage of dose excreted | Geometric Coefficient of Variation 65.2 |
| SAD Group I 100mg | KH176: Percentage of Administered Dose Excreted in Urine: SAD | 10.9 percentage of dose excreted | Geometric Coefficient of Variation 41.6 |
| SAD Group II 300mg | KH176: Percentage of Administered Dose Excreted in Urine: SAD | 12.4 percentage of dose excreted | Geometric Coefficient of Variation 20.7 |
Primary
KH183: Percentage of Administered Dose Excreted in Urine: MAD
Urine concentrations of KH183 were analysed after multiple-dose administration of doses of 100, 200 and 400 mg b.i.d.
Time frame: Post dose Day 7
Population: Per protocol set. The placebo subjects were excluded from the Pharmacokinetics (PK) analysis per-protocol set.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Group I Placebo | KH183: Percentage of Administered Dose Excreted in Urine: MAD | 5.30 percentage of dose excreted | Geometric Coefficient of Variation 120.2 |
| Group II Placebo | KH183: Percentage of Administered Dose Excreted in Urine: MAD | 3.79 percentage of dose excreted | Geometric Coefficient of Variation 39.2 |
| SAD Group I 10mg | KH183: Percentage of Administered Dose Excreted in Urine: MAD | 4.85 percentage of dose excreted | Geometric Coefficient of Variation 43.8 |
Primary
KH183: Percentage of Administered Dose Excreted in Urine: SAD
Urine concentrations of KH176 were analysed after single dose administration of doses 10mg, 30mg, 100mg (with and without food), 300mg, 800mg, 2000mg b.i.d.
Time frame: 24 hours post-dose
Population: Per protocol set
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Group I Placebo | KH183: Percentage of Administered Dose Excreted in Urine: SAD | 4.56 percentage of dose excreted | Geometric Coefficient of Variation 53 |
| Group II Placebo | KH183: Percentage of Administered Dose Excreted in Urine: SAD | 6.42 percentage of dose excreted | Geometric Coefficient of Variation 14.5 |
| SAD Group I 10mg | KH183: Percentage of Administered Dose Excreted in Urine: SAD | 5.18 percentage of dose excreted | Geometric Coefficient of Variation 28.8 |
| SAD Group II 30mg | KH183: Percentage of Administered Dose Excreted in Urine: SAD | 3.81 percentage of dose excreted | Geometric Coefficient of Variation 82.9 |
| SAD Group I 100mg | KH183: Percentage of Administered Dose Excreted in Urine: SAD | 3.86 percentage of dose excreted | Geometric Coefficient of Variation 31 |
| SAD Group II 300mg | KH183: Percentage of Administered Dose Excreted in Urine: SAD | 3.33 percentage of dose excreted | Geometric Coefficient of Variation 32.8 |
Primary
MAD: Change From Baseline in ECG Results by Time Point: Corrected QT Interval According to Barret's Formaula (QTcB)
The baseline ECG recording consists of a triplicate recording (3 recordings of a least 3 complexes within a 5 minute window) prior to dosing on Day 1. For the evaluation the average of the 3 recordings will be taken as baseline. Other ECG recordings will be singlet (one recording of at least 3 complexes) prior to dosing, or around the expected Cmax on Day 1 or 7 for the multiple- dose part.
Time frame: Baseline (pre-dose Day 1), Day1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Follow-up
Population: Safety Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group I Placebo | MAD: Change From Baseline in ECG Results by Time Point: Corrected QT Interval According to Barret's Formaula (QTcB) | Change from BL at pre-dose Day 4 | 6.5 msec | Standard Deviation 11.5 |
| Group I Placebo | MAD: Change From Baseline in ECG Results by Time Point: Corrected QT Interval According to Barret's Formaula (QTcB) | Change from baseline at 2h - Day 1 | 3.8 msec | Standard Deviation 10.3 |
| Group I Placebo | MAD: Change From Baseline in ECG Results by Time Point: Corrected QT Interval According to Barret's Formaula (QTcB) | Change from BL at pre-dose Day 3 | 6.0 msec | Standard Deviation 14.1 |
| Group I Placebo | MAD: Change From Baseline in ECG Results by Time Point: Corrected QT Interval According to Barret's Formaula (QTcB) | Change from pre-dose Day 7 at 2h - Day 7 | -5.0 msec | Standard Deviation 4.2 |
| Group I Placebo | MAD: Change From Baseline in ECG Results by Time Point: Corrected QT Interval According to Barret's Formaula (QTcB) | Baseline (Pre-dose Day 1) | 391.3 msec | Standard Deviation 10.8 |
| Group I Placebo | MAD: Change From Baseline in ECG Results by Time Point: Corrected QT Interval According to Barret's Formaula (QTcB) | Change from BL at pre-dose Day 2 | -1.0 msec | Standard Deviation 9.8 |
| Group I Placebo | MAD: Change From Baseline in ECG Results by Time Point: Corrected QT Interval According to Barret's Formaula (QTcB) | Change from BL at pre-dose Day 6 | 5.5 msec | Standard Deviation 9.9 |
| Group I Placebo | MAD: Change From Baseline in ECG Results by Time Point: Corrected QT Interval According to Barret's Formaula (QTcB) | Change from pre-dose Day 7 at 4h | -7.8 msec | Standard Deviation 7.7 |
| Group I Placebo | MAD: Change From Baseline in ECG Results by Time Point: Corrected QT Interval According to Barret's Formaula (QTcB) | Change from pre-dose Day 7 at 12h - Day 7 | 4.5 msec | Standard Deviation 11.4 |
| Group I Placebo | MAD: Change From Baseline in ECG Results by Time Point: Corrected QT Interval According to Barret's Formaula (QTcB) | Baseline (pre-dose Day 7) | 398.3 msec | Standard Deviation 7.9 |
| Group I Placebo | MAD: Change From Baseline in ECG Results by Time Point: Corrected QT Interval According to Barret's Formaula (QTcB) | Change from BL at pre-dose Day 7 | 7.0 msec | Standard Deviation 6.5 |
| Group I Placebo | MAD: Change From Baseline in ECG Results by Time Point: Corrected QT Interval According to Barret's Formaula (QTcB) | Change from pre-dose Day 7 BL at 6h - Day 7 | 5.3 msec | Standard Deviation 9.8 |
| Group I Placebo | MAD: Change From Baseline in ECG Results by Time Point: Corrected QT Interval According to Barret's Formaula (QTcB) | Change from pre-dose Day 7 at 1h - Day 7 | -3.8 msec | Standard Deviation 9.1 |
| Group I Placebo | MAD: Change From Baseline in ECG Results by Time Point: Corrected QT Interval According to Barret's Formaula (QTcB) | Change from BL at FU | 7.8 msec | Standard Deviation 9.7 |
| Group I Placebo | MAD: Change From Baseline in ECG Results by Time Point: Corrected QT Interval According to Barret's Formaula (QTcB) | Change from BL at pre-dose Day 5 | 13.8 msec | Standard Deviation 14.3 |
| Group I Placebo | MAD: Change From Baseline in ECG Results by Time Point: Corrected QT Interval According to Barret's Formaula (QTcB) | Change from pre-dose Day 7 at 8h - Day 7 | -7.0 msec | Standard Deviation 2.8 |
| Group I Placebo | MAD: Change From Baseline in ECG Results by Time Point: Corrected QT Interval According to Barret's Formaula (QTcB) | Change from BL at 24h - Day 1 | -1.0 msec | Standard Deviation 9.8 |
| Group II Placebo | MAD: Change From Baseline in ECG Results by Time Point: Corrected QT Interval According to Barret's Formaula (QTcB) | Change from pre-dose Day 7 at 8h - Day 7 | -4.5 msec | Standard Deviation 9.7 |
| Group II Placebo | MAD: Change From Baseline in ECG Results by Time Point: Corrected QT Interval According to Barret's Formaula (QTcB) | Change from BL at pre-dose Day 4 | 2.0 msec | Standard Deviation 14.7 |
| Group II Placebo | MAD: Change From Baseline in ECG Results by Time Point: Corrected QT Interval According to Barret's Formaula (QTcB) | Change from pre-dose Day 7 at 12h - Day 7 | 3.0 msec | Standard Deviation 5 |
| Group II Placebo | MAD: Change From Baseline in ECG Results by Time Point: Corrected QT Interval According to Barret's Formaula (QTcB) | Change from BL at 24h - Day 1 | 0.3 msec | Standard Deviation 6.2 |
| Group II Placebo | MAD: Change From Baseline in ECG Results by Time Point: Corrected QT Interval According to Barret's Formaula (QTcB) | Change from BL at pre-dose Day 2 | 0.3 msec | Standard Deviation 6.2 |
| Group II Placebo | MAD: Change From Baseline in ECG Results by Time Point: Corrected QT Interval According to Barret's Formaula (QTcB) | Change from BL at pre-dose Day 3 | 0.5 msec | Standard Deviation 9.7 |
| Group II Placebo | MAD: Change From Baseline in ECG Results by Time Point: Corrected QT Interval According to Barret's Formaula (QTcB) | Change from BL at pre-dose Day 7 | 5.5 msec | Standard Deviation 9.6 |
| Group II Placebo | MAD: Change From Baseline in ECG Results by Time Point: Corrected QT Interval According to Barret's Formaula (QTcB) | Baseline (pre-dose Day 7) | 386.5 msec | Standard Deviation 26.1 |
| Group II Placebo | MAD: Change From Baseline in ECG Results by Time Point: Corrected QT Interval According to Barret's Formaula (QTcB) | Change from BL at FU | 11.0 msec | Standard Deviation 3.2 |
| Group II Placebo | MAD: Change From Baseline in ECG Results by Time Point: Corrected QT Interval According to Barret's Formaula (QTcB) | Change from pre-dose Day 7 at 1h - Day 7 | -3.8 msec | Standard Deviation 7.9 |
| Group II Placebo | MAD: Change From Baseline in ECG Results by Time Point: Corrected QT Interval According to Barret's Formaula (QTcB) | Change from BL at pre-dose Day 6 | -2.3 msec | Standard Deviation 6.7 |
| Group II Placebo | MAD: Change From Baseline in ECG Results by Time Point: Corrected QT Interval According to Barret's Formaula (QTcB) | Change from pre-dose Day 7 at 2h - Day 7 | 5.8 msec | Standard Deviation 15.2 |
| Group II Placebo | MAD: Change From Baseline in ECG Results by Time Point: Corrected QT Interval According to Barret's Formaula (QTcB) | Change from baseline at 2h - Day 1 | 12.3 msec | Standard Deviation 8.8 |
| Group II Placebo | MAD: Change From Baseline in ECG Results by Time Point: Corrected QT Interval According to Barret's Formaula (QTcB) | Change from pre-dose Day 7 at 4h | -3.8 msec | Standard Deviation 6.2 |
| Group II Placebo | MAD: Change From Baseline in ECG Results by Time Point: Corrected QT Interval According to Barret's Formaula (QTcB) | Baseline (Pre-dose Day 1) | 381.0 msec | Standard Deviation 28.9 |
| Group II Placebo | MAD: Change From Baseline in ECG Results by Time Point: Corrected QT Interval According to Barret's Formaula (QTcB) | Change from BL at pre-dose Day 5 | 10.3 msec | Standard Deviation 4.3 |
| Group II Placebo | MAD: Change From Baseline in ECG Results by Time Point: Corrected QT Interval According to Barret's Formaula (QTcB) | Change from pre-dose Day 7 BL at 6h - Day 7 | 12.5 msec | Standard Deviation 7 |
| SAD Group I 10mg | MAD: Change From Baseline in ECG Results by Time Point: Corrected QT Interval According to Barret's Formaula (QTcB) | Change from BL at pre-dose Day 2 | 11.5 msec | Standard Deviation 19.2 |
| SAD Group I 10mg | MAD: Change From Baseline in ECG Results by Time Point: Corrected QT Interval According to Barret's Formaula (QTcB) | Baseline (Pre-dose Day 1) | 384.0 msec | Standard Deviation 11 |
| SAD Group I 10mg | MAD: Change From Baseline in ECG Results by Time Point: Corrected QT Interval According to Barret's Formaula (QTcB) | Change from baseline at 2h - Day 1 | 11.8 msec | Standard Deviation 9.7 |
| SAD Group I 10mg | MAD: Change From Baseline in ECG Results by Time Point: Corrected QT Interval According to Barret's Formaula (QTcB) | Change from BL at 24h - Day 1 | 11.5 msec | Standard Deviation 19.2 |
| SAD Group I 10mg | MAD: Change From Baseline in ECG Results by Time Point: Corrected QT Interval According to Barret's Formaula (QTcB) | Baseline (pre-dose Day 7) | 402.0 msec | Standard Deviation 6.6 |
| SAD Group I 10mg | MAD: Change From Baseline in ECG Results by Time Point: Corrected QT Interval According to Barret's Formaula (QTcB) | Change from pre-dose Day 7 at 1h - Day 7 | -10.3 msec | Standard Deviation 11.1 |
| SAD Group I 10mg | MAD: Change From Baseline in ECG Results by Time Point: Corrected QT Interval According to Barret's Formaula (QTcB) | Change from pre-dose Day 7 at 2h - Day 7 | 2.5 msec | Standard Deviation 8.7 |
| SAD Group I 10mg | MAD: Change From Baseline in ECG Results by Time Point: Corrected QT Interval According to Barret's Formaula (QTcB) | Change from pre-dose Day 7 at 4h | -6.5 msec | Standard Deviation 13.9 |
| SAD Group I 10mg | MAD: Change From Baseline in ECG Results by Time Point: Corrected QT Interval According to Barret's Formaula (QTcB) | Change from pre-dose Day 7 BL at 6h - Day 7 | -1.8 msec | Standard Deviation 8.3 |
| SAD Group I 10mg | MAD: Change From Baseline in ECG Results by Time Point: Corrected QT Interval According to Barret's Formaula (QTcB) | Change from pre-dose Day 7 at 8h - Day 7 | -11.5 msec | Standard Deviation 7.2 |
| SAD Group I 10mg | MAD: Change From Baseline in ECG Results by Time Point: Corrected QT Interval According to Barret's Formaula (QTcB) | Change from pre-dose Day 7 at 12h - Day 7 | -9.0 msec | Standard Deviation 8.1 |
| SAD Group I 10mg | MAD: Change From Baseline in ECG Results by Time Point: Corrected QT Interval According to Barret's Formaula (QTcB) | Change from BL at pre-dose Day 3 | 20.5 msec | Standard Deviation 22.3 |
| SAD Group I 10mg | MAD: Change From Baseline in ECG Results by Time Point: Corrected QT Interval According to Barret's Formaula (QTcB) | Change from BL at pre-dose Day 4 | 7.5 msec | Standard Deviation 17.1 |
| SAD Group I 10mg | MAD: Change From Baseline in ECG Results by Time Point: Corrected QT Interval According to Barret's Formaula (QTcB) | Change from BL at pre-dose Day 5 | 14.0 msec | Standard Deviation 14.2 |
| SAD Group I 10mg | MAD: Change From Baseline in ECG Results by Time Point: Corrected QT Interval According to Barret's Formaula (QTcB) | Change from BL at pre-dose Day 6 | 13.5 msec | Standard Deviation 13.8 |
| SAD Group I 10mg | MAD: Change From Baseline in ECG Results by Time Point: Corrected QT Interval According to Barret's Formaula (QTcB) | Change from BL at pre-dose Day 7 | 18.0 msec | Standard Deviation 9.2 |
| SAD Group I 10mg | MAD: Change From Baseline in ECG Results by Time Point: Corrected QT Interval According to Barret's Formaula (QTcB) | Change from BL at FU | 10.5 msec | Standard Deviation 24.4 |
| SAD Group II 30mg | MAD: Change From Baseline in ECG Results by Time Point: Corrected QT Interval According to Barret's Formaula (QTcB) | Change from BL at pre-dose Day 4 | -10.2 msec | Standard Deviation 5 |
| SAD Group II 30mg | MAD: Change From Baseline in ECG Results by Time Point: Corrected QT Interval According to Barret's Formaula (QTcB) | Change from pre-dose Day 7 BL at 6h - Day 7 | 5.8 msec | Standard Deviation 23.5 |
| SAD Group II 30mg | MAD: Change From Baseline in ECG Results by Time Point: Corrected QT Interval According to Barret's Formaula (QTcB) | Change from pre-dose Day 7 at 4h | -0.5 msec | Standard Deviation 12.1 |
| SAD Group II 30mg | MAD: Change From Baseline in ECG Results by Time Point: Corrected QT Interval According to Barret's Formaula (QTcB) | Change from baseline at 2h - Day 1 | 0.7 msec | Standard Deviation 6.9 |
| SAD Group II 30mg | MAD: Change From Baseline in ECG Results by Time Point: Corrected QT Interval According to Barret's Formaula (QTcB) | Change from BL at pre-dose Day 5 | -8.5 msec | Standard Deviation 5.6 |
| SAD Group II 30mg | MAD: Change From Baseline in ECG Results by Time Point: Corrected QT Interval According to Barret's Formaula (QTcB) | Change from pre-dose Day 7 at 2h - Day 7 | 1.0 msec | Standard Deviation 16.2 |
| SAD Group II 30mg | MAD: Change From Baseline in ECG Results by Time Point: Corrected QT Interval According to Barret's Formaula (QTcB) | Change from pre-dose Day 7 at 1h - Day 7 | -3.5 msec | Standard Deviation 6 |
| SAD Group II 30mg | MAD: Change From Baseline in ECG Results by Time Point: Corrected QT Interval According to Barret's Formaula (QTcB) | Baseline (Pre-dose Day 1) | 385.2 msec | Standard Deviation 15.4 |
| SAD Group II 30mg | MAD: Change From Baseline in ECG Results by Time Point: Corrected QT Interval According to Barret's Formaula (QTcB) | Change from BL at pre-dose Day 6 | -10.5 msec | Standard Deviation 14.5 |
| SAD Group II 30mg | MAD: Change From Baseline in ECG Results by Time Point: Corrected QT Interval According to Barret's Formaula (QTcB) | Baseline (pre-dose Day 7) | 378.8 msec | Standard Deviation 13.3 |
| SAD Group II 30mg | MAD: Change From Baseline in ECG Results by Time Point: Corrected QT Interval According to Barret's Formaula (QTcB) | Change from BL at 24h - Day 1 | -5.7 msec | Standard Deviation 9.7 |
| SAD Group II 30mg | MAD: Change From Baseline in ECG Results by Time Point: Corrected QT Interval According to Barret's Formaula (QTcB) | Change from BL at pre-dose Day 2 | -5.7 msec | Standard Deviation 9.7 |
| SAD Group II 30mg | MAD: Change From Baseline in ECG Results by Time Point: Corrected QT Interval According to Barret's Formaula (QTcB) | Change from BL at FU | 3.8 msec | Standard Deviation 14.3 |
| SAD Group II 30mg | MAD: Change From Baseline in ECG Results by Time Point: Corrected QT Interval According to Barret's Formaula (QTcB) | Change from BL at pre-dose Day 3 | -8.5 msec | Standard Deviation 5.8 |
| SAD Group II 30mg | MAD: Change From Baseline in ECG Results by Time Point: Corrected QT Interval According to Barret's Formaula (QTcB) | Change from pre-dose Day 7 at 12h - Day 7 | 6.7 msec | Standard Deviation 5.7 |
| SAD Group II 30mg | MAD: Change From Baseline in ECG Results by Time Point: Corrected QT Interval According to Barret's Formaula (QTcB) | Change from pre-dose Day 7 at 8h - Day 7 | 3.0 msec | Standard Deviation 6.9 |
| SAD Group II 30mg | MAD: Change From Baseline in ECG Results by Time Point: Corrected QT Interval According to Barret's Formaula (QTcB) | Change from BL at pre-dose Day 7 | -11.3 msec | Standard Deviation 7.7 |
Primary
MAD: Change From Baseline in ECG Results by Time Point: P Wave-Q Wave Interval (PQ Interval)
The baseline ECG recording consists of a triplicate recording (3 recordings of a least 3 complexes within a 5 minute window) prior to dosing on Day 1. For the evaluation of the PQ interval the average of the 3 recordings will be taken as baseline.
Time frame: Baseline (pre-dose Day 1), Day1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Follow-up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group I Placebo | MAD: Change From Baseline in ECG Results by Time Point: P Wave-Q Wave Interval (PQ Interval) | Change from pre-dose Day 7 at 1h - Day 7 | -1.0 msec | Standard Deviation 4.8 |
| Group I Placebo | MAD: Change From Baseline in ECG Results by Time Point: P Wave-Q Wave Interval (PQ Interval) | Change from BL at pre-dose Day 4 | 6.3 msec | Standard Deviation 3.3 |
| Group I Placebo | MAD: Change From Baseline in ECG Results by Time Point: P Wave-Q Wave Interval (PQ Interval) | Change from BL at pre-dose Day 3 | 6.3 msec | Standard Deviation 5.4 |
| Group I Placebo | MAD: Change From Baseline in ECG Results by Time Point: P Wave-Q Wave Interval (PQ Interval) | Change from baseline at 2h - Day 1 | 2.8 msec | Standard Deviation 2.8 |
| Group I Placebo | MAD: Change From Baseline in ECG Results by Time Point: P Wave-Q Wave Interval (PQ Interval) | Change from pre-dose Day 7 at 2h - Day 7 | -3.5 msec | Standard Deviation 5.7 |
| Group I Placebo | MAD: Change From Baseline in ECG Results by Time Point: P Wave-Q Wave Interval (PQ Interval) | Change from BL at pre-dose Day 2 | -5.8 msec | Standard Deviation 6.1 |
| Group I Placebo | MAD: Change From Baseline in ECG Results by Time Point: P Wave-Q Wave Interval (PQ Interval) | Change from BL at FU | -6.8 msec | Standard Deviation 12 |
| Group I Placebo | MAD: Change From Baseline in ECG Results by Time Point: P Wave-Q Wave Interval (PQ Interval) | Change from BL at pre-dose Day 6 | -0.3 msec | Standard Deviation 9.5 |
| Group I Placebo | MAD: Change From Baseline in ECG Results by Time Point: P Wave-Q Wave Interval (PQ Interval) | Change from pre-dose Day 7 at 4h | -9.0 msec | Standard Deviation 9 |
| Group I Placebo | MAD: Change From Baseline in ECG Results by Time Point: P Wave-Q Wave Interval (PQ Interval) | Baseline (pre-dose Day 7) | 191.5 msec | Standard Deviation 33.4 |
| Group I Placebo | MAD: Change From Baseline in ECG Results by Time Point: P Wave-Q Wave Interval (PQ Interval) | Change from pre-dose Day 7 at 12h - Day 7 | -24.0 msec | Standard Deviation 23.6 |
| Group I Placebo | MAD: Change From Baseline in ECG Results by Time Point: P Wave-Q Wave Interval (PQ Interval) | Change from pre-dose Day 7 BL at 6h - Day 7 | -13.0 msec | Standard Deviation 4.8 |
| Group I Placebo | MAD: Change From Baseline in ECG Results by Time Point: P Wave-Q Wave Interval (PQ Interval) | Baseline (Pre-dose Day 1) | 185.8 msec | Standard Deviation 33.4 |
| Group I Placebo | MAD: Change From Baseline in ECG Results by Time Point: P Wave-Q Wave Interval (PQ Interval) | Change from BL at 24h - Day 1 | -5.8 msec | Standard Deviation 6.1 |
| Group I Placebo | MAD: Change From Baseline in ECG Results by Time Point: P Wave-Q Wave Interval (PQ Interval) | Change from BL at pre-dose Day 5 | -2.3 msec | Standard Deviation 7.4 |
| Group I Placebo | MAD: Change From Baseline in ECG Results by Time Point: P Wave-Q Wave Interval (PQ Interval) | Change from pre-dose Day 7 at 8h - Day 7 | -10.0 msec | Standard Deviation 5.9 |
| Group I Placebo | MAD: Change From Baseline in ECG Results by Time Point: P Wave-Q Wave Interval (PQ Interval) | Change from BL at pre-dose Day 7 | 5.8 msec | Standard Deviation 6.8 |
| Group II Placebo | MAD: Change From Baseline in ECG Results by Time Point: P Wave-Q Wave Interval (PQ Interval) | Change from pre-dose Day 7 at 8h - Day 7 | 0.0 msec | Standard Deviation 7.3 |
| Group II Placebo | MAD: Change From Baseline in ECG Results by Time Point: P Wave-Q Wave Interval (PQ Interval) | Change from BL at pre-dose Day 4 | 9.5 msec | Standard Deviation 1 |
| Group II Placebo | MAD: Change From Baseline in ECG Results by Time Point: P Wave-Q Wave Interval (PQ Interval) | Change from pre-dose Day 7 at 12h - Day 7 | -1.5 msec | Standard Deviation 5.7 |
| Group II Placebo | MAD: Change From Baseline in ECG Results by Time Point: P Wave-Q Wave Interval (PQ Interval) | Change from BL at FU | -2.5 msec | Standard Deviation 3.4 |
| Group II Placebo | MAD: Change From Baseline in ECG Results by Time Point: P Wave-Q Wave Interval (PQ Interval) | Change from BL at pre-dose Day 2 | -0.5 msec | Standard Deviation 1.9 |
| Group II Placebo | MAD: Change From Baseline in ECG Results by Time Point: P Wave-Q Wave Interval (PQ Interval) | Change from BL at pre-dose Day 3 | 4.5 msec | Standard Deviation 2.5 |
| Group II Placebo | MAD: Change From Baseline in ECG Results by Time Point: P Wave-Q Wave Interval (PQ Interval) | Change from BL at pre-dose Day 7 | 3.5 msec | Standard Deviation 5.7 |
| Group II Placebo | MAD: Change From Baseline in ECG Results by Time Point: P Wave-Q Wave Interval (PQ Interval) | Baseline (pre-dose Day 7) | 164.0 msec | Standard Deviation 22.9 |
| Group II Placebo | MAD: Change From Baseline in ECG Results by Time Point: P Wave-Q Wave Interval (PQ Interval) | Change from baseline at 2h - Day 1 | -1.5 msec | Standard Deviation 3 |
| Group II Placebo | MAD: Change From Baseline in ECG Results by Time Point: P Wave-Q Wave Interval (PQ Interval) | Change from pre-dose Day 7 at 1h - Day 7 | 5.5 msec | Standard Deviation 30 |
| Group II Placebo | MAD: Change From Baseline in ECG Results by Time Point: P Wave-Q Wave Interval (PQ Interval) | Baseline (Pre-dose Day 1) | 160.5 msec | Standard Deviation 18.5 |
| Group II Placebo | MAD: Change From Baseline in ECG Results by Time Point: P Wave-Q Wave Interval (PQ Interval) | Change from BL at pre-dose Day 6 | 3.0 msec | Standard Deviation 4.3 |
| Group II Placebo | MAD: Change From Baseline in ECG Results by Time Point: P Wave-Q Wave Interval (PQ Interval) | Change from pre-dose Day 7 at 2h - Day 7 | -1.5 msec | Standard Deviation 3.4 |
| Group II Placebo | MAD: Change From Baseline in ECG Results by Time Point: P Wave-Q Wave Interval (PQ Interval) | Change from pre-dose Day 7 at 4h | -1.0 msec | Standard Deviation 3.8 |
| Group II Placebo | MAD: Change From Baseline in ECG Results by Time Point: P Wave-Q Wave Interval (PQ Interval) | Change from BL at pre-dose Day 5 | 4.0 msec | Standard Deviation 6.2 |
| Group II Placebo | MAD: Change From Baseline in ECG Results by Time Point: P Wave-Q Wave Interval (PQ Interval) | Change from pre-dose Day 7 BL at 6h - Day 7 | -3.5 msec | Standard Deviation 8.2 |
| Group II Placebo | MAD: Change From Baseline in ECG Results by Time Point: P Wave-Q Wave Interval (PQ Interval) | Change from BL at 24h - Day 1 | -0.5 msec | Standard Deviation 1.9 |
| SAD Group I 10mg | MAD: Change From Baseline in ECG Results by Time Point: P Wave-Q Wave Interval (PQ Interval) | Change from BL at pre-dose Day 2 | 2.0 msec | Standard Deviation 6.6 |
| SAD Group I 10mg | MAD: Change From Baseline in ECG Results by Time Point: P Wave-Q Wave Interval (PQ Interval) | Baseline (Pre-dose Day 1) | 162.0 msec | Standard Deviation 7 |
| SAD Group I 10mg | MAD: Change From Baseline in ECG Results by Time Point: P Wave-Q Wave Interval (PQ Interval) | Change from baseline at 2h - Day 1 | 6.0 msec | Standard Deviation 5 |
| SAD Group I 10mg | MAD: Change From Baseline in ECG Results by Time Point: P Wave-Q Wave Interval (PQ Interval) | Change from BL at 24h - Day 1 | 2.0 msec | Standard Deviation 6.6 |
| SAD Group I 10mg | MAD: Change From Baseline in ECG Results by Time Point: P Wave-Q Wave Interval (PQ Interval) | Change from pre-dose Day 7 at 4h | 0.0 msec | Standard Deviation 1.6 |
| SAD Group I 10mg | MAD: Change From Baseline in ECG Results by Time Point: P Wave-Q Wave Interval (PQ Interval) | Baseline (pre-dose Day 7) | 167.5 msec | Standard Deviation 5.3 |
| SAD Group I 10mg | MAD: Change From Baseline in ECG Results by Time Point: P Wave-Q Wave Interval (PQ Interval) | Change from pre-dose Day 7 at 1h - Day 7 | 6.5 msec | Standard Deviation 2.5 |
| SAD Group I 10mg | MAD: Change From Baseline in ECG Results by Time Point: P Wave-Q Wave Interval (PQ Interval) | Change from pre-dose Day 7 at 2h - Day 7 | 4.0 msec | Standard Deviation 4.3 |
| SAD Group I 10mg | MAD: Change From Baseline in ECG Results by Time Point: P Wave-Q Wave Interval (PQ Interval) | Change from pre-dose Day 7 BL at 6h - Day 7 | -4.5 msec | Standard Deviation 2.5 |
| SAD Group I 10mg | MAD: Change From Baseline in ECG Results by Time Point: P Wave-Q Wave Interval (PQ Interval) | Change from pre-dose Day 7 at 8h - Day 7 | -5.0 msec | Standard Deviation 2.6 |
| SAD Group I 10mg | MAD: Change From Baseline in ECG Results by Time Point: P Wave-Q Wave Interval (PQ Interval) | Change from pre-dose Day 7 at 12h - Day 7 | -4.5 msec | Standard Deviation 4.1 |
| SAD Group I 10mg | MAD: Change From Baseline in ECG Results by Time Point: P Wave-Q Wave Interval (PQ Interval) | Change from BL at pre-dose Day 3 | 0.0 msec | Standard Deviation 6.8 |
| SAD Group I 10mg | MAD: Change From Baseline in ECG Results by Time Point: P Wave-Q Wave Interval (PQ Interval) | Change from BL at pre-dose Day 4 | 7.5 msec | Standard Deviation 6.8 |
| SAD Group I 10mg | MAD: Change From Baseline in ECG Results by Time Point: P Wave-Q Wave Interval (PQ Interval) | Change from BL at pre-dose Day 5 | 8.5 msec | Standard Deviation 10.1 |
| SAD Group I 10mg | MAD: Change From Baseline in ECG Results by Time Point: P Wave-Q Wave Interval (PQ Interval) | Change from BL at pre-dose Day 6 | 6.0 msec | Standard Deviation 3.5 |
| SAD Group I 10mg | MAD: Change From Baseline in ECG Results by Time Point: P Wave-Q Wave Interval (PQ Interval) | Change from BL at pre-dose Day 7 | 5.5 msec | Standard Deviation 5.7 |
| SAD Group I 10mg | MAD: Change From Baseline in ECG Results by Time Point: P Wave-Q Wave Interval (PQ Interval) | Change from BL at FU | -3.5 msec | Standard Deviation 6.4 |
| SAD Group II 30mg | MAD: Change From Baseline in ECG Results by Time Point: P Wave-Q Wave Interval (PQ Interval) | Change from BL at pre-dose Day 4 | -3.8 msec | Standard Deviation 19.7 |
| SAD Group II 30mg | MAD: Change From Baseline in ECG Results by Time Point: P Wave-Q Wave Interval (PQ Interval) | Change from pre-dose Day 7 BL at 6h - Day 7 | -6.7 msec | Standard Deviation 5.2 |
| SAD Group II 30mg | MAD: Change From Baseline in ECG Results by Time Point: P Wave-Q Wave Interval (PQ Interval) | Change from pre-dose Day 7 at 4h | -14.3 msec | Standard Deviation 15 |
| SAD Group II 30mg | MAD: Change From Baseline in ECG Results by Time Point: P Wave-Q Wave Interval (PQ Interval) | Change from baseline at 2h - Day 1 | 6.2 msec | Standard Deviation 10.3 |
| SAD Group II 30mg | MAD: Change From Baseline in ECG Results by Time Point: P Wave-Q Wave Interval (PQ Interval) | Change from BL at pre-dose Day 5 | -2.2 msec | Standard Deviation 16.9 |
| SAD Group II 30mg | MAD: Change From Baseline in ECG Results by Time Point: P Wave-Q Wave Interval (PQ Interval) | Change from pre-dose Day 7 at 2h - Day 7 | -14.7 msec | Standard Deviation 14.7 |
| SAD Group II 30mg | MAD: Change From Baseline in ECG Results by Time Point: P Wave-Q Wave Interval (PQ Interval) | Change from pre-dose Day 7 at 1h - Day 7 | -1.7 msec | Standard Deviation 2 |
| SAD Group II 30mg | MAD: Change From Baseline in ECG Results by Time Point: P Wave-Q Wave Interval (PQ Interval) | Baseline (Pre-dose Day 1) | 171.8 msec | Standard Deviation 20 |
| SAD Group II 30mg | MAD: Change From Baseline in ECG Results by Time Point: P Wave-Q Wave Interval (PQ Interval) | Change from BL at pre-dose Day 6 | 5.2 msec | Standard Deviation 19 |
| SAD Group II 30mg | MAD: Change From Baseline in ECG Results by Time Point: P Wave-Q Wave Interval (PQ Interval) | Baseline (pre-dose Day 7) | 178.3 msec | Standard Deviation 11.8 |
| SAD Group II 30mg | MAD: Change From Baseline in ECG Results by Time Point: P Wave-Q Wave Interval (PQ Interval) | Change from BL at 24h - Day 1 | -6.5 msec | Standard Deviation 14 |
| SAD Group II 30mg | MAD: Change From Baseline in ECG Results by Time Point: P Wave-Q Wave Interval (PQ Interval) | Change from BL at pre-dose Day 2 | -6.5 msec | Standard Deviation 14 |
| SAD Group II 30mg | MAD: Change From Baseline in ECG Results by Time Point: P Wave-Q Wave Interval (PQ Interval) | Change from BL at FU | 0.5 msec | Standard Deviation 16.2 |
| SAD Group II 30mg | MAD: Change From Baseline in ECG Results by Time Point: P Wave-Q Wave Interval (PQ Interval) | Change from BL at pre-dose Day 3 | -6.8 msec | Standard Deviation 7.3 |
| SAD Group II 30mg | MAD: Change From Baseline in ECG Results by Time Point: P Wave-Q Wave Interval (PQ Interval) | Change from pre-dose Day 7 at 12h - Day 7 | -4.0 msec | Standard Deviation 7.6 |
| SAD Group II 30mg | MAD: Change From Baseline in ECG Results by Time Point: P Wave-Q Wave Interval (PQ Interval) | Change from pre-dose Day 7 at 8h - Day 7 | -11.3 msec | Standard Deviation 4.1 |
| SAD Group II 30mg | MAD: Change From Baseline in ECG Results by Time Point: P Wave-Q Wave Interval (PQ Interval) | Change from BL at pre-dose Day 7 | 6.5 msec | Standard Deviation 20.9 |
Primary
MAD: Change From Baseline in ECG Results by Time Point: QTcF
The baseline ECG recording consists of a triplicate recording (3 recordings of a least 3 complexes within a 5 minute window) prior to dosing on Day 1. For the evaluation of the corrected QT intervals the average of the 3 recordings will be taken as baseline. Other ECG recordings will be singlet (one recording of at least 3 complexes) prior to dosing, or around the expected Cmax on Day 1 or 7 for the multiple-dose part. QTcF is calculated as the quotient between the QT interval in milliseconds and the cube root of the RR interval in seconds, according to Fridericia's formula.
Time frame: Baseline, Day1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7
Population: The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group I Placebo | MAD: Change From Baseline in ECG Results by Time Point: QTcF | Change from BL Day 7 at 12h - Day 7 | -4.3 msec | Standard Deviation 4.6 |
| Group I Placebo | MAD: Change From Baseline in ECG Results by Time Point: QTcF | Change from BL Day 7 BL at 6h - Day 7 | -1.8 msec | Standard Deviation 7.3 |
| Group I Placebo | MAD: Change From Baseline in ECG Results by Time Point: QTcF | Change from BL Day 7 at 8h - Day 7 | -11.3 msec | Standard Deviation 3.2 |
| Group I Placebo | MAD: Change From Baseline in ECG Results by Time Point: QTcF | Baseline (Pre-dose Day 1) | 397.3 msec | Standard Deviation 18.4 |
| Group I Placebo | MAD: Change From Baseline in ECG Results by Time Point: QTcF | Change from BL at pre-dose Day 7 | -1.0 msec | Standard Deviation 11.9 |
| Group I Placebo | MAD: Change From Baseline in ECG Results by Time Point: QTcF | Change from BL Day 7 at 4h | -7.5 msec | Standard Deviation 4.7 |
| Group I Placebo | MAD: Change From Baseline in ECG Results by Time Point: QTcF | Change from BL at pre-dose Day 6 | -1.3 msec | Standard Deviation 12.5 |
| Group I Placebo | MAD: Change From Baseline in ECG Results by Time Point: QTcF | Change from BL at 2h - Day 1 | 0.5 msec | Standard Deviation 7.5 |
| Group I Placebo | MAD: Change From Baseline in ECG Results by Time Point: QTcF | Change from BL Day 7 at 1h - Day 7 | -1.3 msec | Standard Deviation 10.2 |
| Group I Placebo | MAD: Change From Baseline in ECG Results by Time Point: QTcF | Change from BL at pre-dose Day 5 | 6.0 msec | Standard Deviation 13.3 |
| Group I Placebo | MAD: Change From Baseline in ECG Results by Time Point: QTcF | Change from BL at pre-dose Day 4 | 2.5 msec | Standard Deviation 14.6 |
| Group I Placebo | MAD: Change From Baseline in ECG Results by Time Point: QTcF | Change from BL Day 7 at 2h - Day 7 | -3.5 msec | Standard Deviation 2.5 |
| Group I Placebo | MAD: Change From Baseline in ECG Results by Time Point: QTcF | Change from BL at FU | -2.3 msec | Standard Deviation 5 |
| Group I Placebo | MAD: Change From Baseline in ECG Results by Time Point: QTcF | Change from BL at pre-dose Day 3 | 0.5 msec | Standard Deviation 8.6 |
| Group I Placebo | MAD: Change From Baseline in ECG Results by Time Point: QTcF | Change from BL at pre-dose Day 2 | -4.3 msec | Standard Deviation 6.6 |
| Group I Placebo | MAD: Change From Baseline in ECG Results by Time Point: QTcF | Change from BL at 24h - Day 1 | -4.3 msec | Standard Deviation 6.6 |
| Group II Placebo | MAD: Change From Baseline in ECG Results by Time Point: QTcF | Change from BL at FU | 4.0 msec | Standard Deviation 6.3 |
| Group II Placebo | MAD: Change From Baseline in ECG Results by Time Point: QTcF | Baseline (Pre-dose Day 1) | 384.3 msec | Standard Deviation 21.7 |
| Group II Placebo | MAD: Change From Baseline in ECG Results by Time Point: QTcF | Change from BL at 24h - Day 1 | 0.5 msec | Standard Deviation 5.7 |
| Group II Placebo | MAD: Change From Baseline in ECG Results by Time Point: QTcF | Change from BL Day 7 at 2h - Day 7 | -0.3 msec | Standard Deviation 8.2 |
| Group II Placebo | MAD: Change From Baseline in ECG Results by Time Point: QTcF | Change from BL Day 7 BL at 6h - Day 7 | 2.0 msec | Standard Deviation 4.7 |
| Group II Placebo | MAD: Change From Baseline in ECG Results by Time Point: QTcF | Change from BL Day 7 at 8h - Day 7 | -3.8 msec | Standard Deviation 6.9 |
| Group II Placebo | MAD: Change From Baseline in ECG Results by Time Point: QTcF | Change from BL Day 7 at 12h - Day 7 | -5.0 msec | Standard Deviation 3.5 |
| Group II Placebo | MAD: Change From Baseline in ECG Results by Time Point: QTcF | Change from BL at pre-dose Day 2 | 0.5 msec | Standard Deviation 5.7 |
| Group II Placebo | MAD: Change From Baseline in ECG Results by Time Point: QTcF | Change from BL at pre-dose Day 4 | 0.5 msec | Standard Deviation 13.6 |
| Group II Placebo | MAD: Change From Baseline in ECG Results by Time Point: QTcF | Change from BL at 2h - Day 1 | 5.5 msec | Standard Deviation 8.1 |
| Group II Placebo | MAD: Change From Baseline in ECG Results by Time Point: QTcF | Change from BL Day 7 at 1h - Day 7 | -3.0 msec | Standard Deviation 3.3 |
| Group II Placebo | MAD: Change From Baseline in ECG Results by Time Point: QTcF | Change from BL Day 7 at 4h | -3.8 msec | Standard Deviation 3.5 |
| Group II Placebo | MAD: Change From Baseline in ECG Results by Time Point: QTcF | Change from BL at pre-dose Day 3 | 2.8 msec | Standard Deviation 6.4 |
| Group II Placebo | MAD: Change From Baseline in ECG Results by Time Point: QTcF | Change from BL at pre-dose Day 5 | 2.5 msec | Standard Deviation 7.2 |
| Group II Placebo | MAD: Change From Baseline in ECG Results by Time Point: QTcF | Change from BL at pre-dose Day 6 | -1.5 msec | Standard Deviation 6.2 |
| Group II Placebo | MAD: Change From Baseline in ECG Results by Time Point: QTcF | Change from BL at pre-dose Day 7 | 3.0 msec | Standard Deviation 9.5 |
| SAD Group I 10mg | MAD: Change From Baseline in ECG Results by Time Point: QTcF | Change from BL at 24h - Day 1 | 3.3 msec | Standard Deviation 13.6 |
| SAD Group I 10mg | MAD: Change From Baseline in ECG Results by Time Point: QTcF | Change from BL Day 7 at 8h - Day 7 | -11.0 msec | Standard Deviation 5.3 |
| SAD Group I 10mg | MAD: Change From Baseline in ECG Results by Time Point: QTcF | Change from BL at pre-dose Day 4 | 7.3 msec | Standard Deviation 10.2 |
| SAD Group I 10mg | MAD: Change From Baseline in ECG Results by Time Point: QTcF | Change from BL Day 7 at 12h - Day 7 | -10.0 msec | Standard Deviation 4.7 |
| SAD Group I 10mg | MAD: Change From Baseline in ECG Results by Time Point: QTcF | Change from BL Day 7 at 1h - Day 7 | -6.5 msec | Standard Deviation 8.1 |
| SAD Group I 10mg | MAD: Change From Baseline in ECG Results by Time Point: QTcF | Change from BL Day 7 BL at 6h - Day 7 | -7.3 msec | Standard Deviation 1.9 |
| SAD Group I 10mg | MAD: Change From Baseline in ECG Results by Time Point: QTcF | Baseline (Pre-dose Day 1) | 388.5 msec | Standard Deviation 4.7 |
| SAD Group I 10mg | MAD: Change From Baseline in ECG Results by Time Point: QTcF | Change from BL Day 7 at 4h | -5.8 msec | Standard Deviation 7.7 |
| SAD Group I 10mg | MAD: Change From Baseline in ECG Results by Time Point: QTcF | Change from BL at pre-dose Day 3 | 10.5 msec | Standard Deviation 17.2 |
| SAD Group I 10mg | MAD: Change From Baseline in ECG Results by Time Point: QTcF | Change from BL at 2h - Day 1 | 7.3 msec | Standard Deviation 7 |
| SAD Group I 10mg | MAD: Change From Baseline in ECG Results by Time Point: QTcF | Change from BL at pre-dose Day 5 | 10.8 msec | Standard Deviation 6.7 |
| SAD Group I 10mg | MAD: Change From Baseline in ECG Results by Time Point: QTcF | Change from BL at pre-dose Day 6 | 7.8 msec | Standard Deviation 8 |
| SAD Group I 10mg | MAD: Change From Baseline in ECG Results by Time Point: QTcF | Change from BL at FU | -0.5 msec | Standard Deviation 14.4 |
| SAD Group I 10mg | MAD: Change From Baseline in ECG Results by Time Point: QTcF | Change from BL Day 7 at 2h - Day 7 | -0.8 msec | Standard Deviation 3.2 |
| SAD Group I 10mg | MAD: Change From Baseline in ECG Results by Time Point: QTcF | Change from BL at pre-dose Day 7 | 13.5 msec | Standard Deviation 8.7 |
| SAD Group I 10mg | MAD: Change From Baseline in ECG Results by Time Point: QTcF | Change from BL at pre-dose Day 2 | 3.3 msec | Standard Deviation 13.6 |
| SAD Group II 30mg | MAD: Change From Baseline in ECG Results by Time Point: QTcF | Change from BL at pre-dose Day 3 | -7.5 msec | Standard Deviation 6.8 |
| SAD Group II 30mg | MAD: Change From Baseline in ECG Results by Time Point: QTcF | Change from BL Day 7 at 4h | 3.0 msec | Standard Deviation 11.2 |
| SAD Group II 30mg | MAD: Change From Baseline in ECG Results by Time Point: QTcF | Change from BL Day 7 BL at 6h - Day 7 | -0.5 msec | Standard Deviation 21 |
| SAD Group II 30mg | MAD: Change From Baseline in ECG Results by Time Point: QTcF | Change from BL Day 7 at 8h - Day 7 | 0.8 msec | Standard Deviation 3.9 |
| SAD Group II 30mg | MAD: Change From Baseline in ECG Results by Time Point: QTcF | Change from BL Day 7 at 12h - Day 7 | 1.7 msec | Standard Deviation 6 |
| SAD Group II 30mg | MAD: Change From Baseline in ECG Results by Time Point: QTcF | Change from BL Day 7 at 2h - Day 7 | -0.3 msec | Standard Deviation 10.1 |
| SAD Group II 30mg | MAD: Change From Baseline in ECG Results by Time Point: QTcF | Change from BL at pre-dose Day 2 | -4.8 msec | Standard Deviation 3.7 |
| SAD Group II 30mg | MAD: Change From Baseline in ECG Results by Time Point: QTcF | Change from BL at pre-dose Day 6 | -8.2 msec | Standard Deviation 11.8 |
| SAD Group II 30mg | MAD: Change From Baseline in ECG Results by Time Point: QTcF | Change from BL Day 7 at 1h - Day 7 | -2.2 msec | Standard Deviation 2.7 |
| SAD Group II 30mg | MAD: Change From Baseline in ECG Results by Time Point: QTcF | Change from BL at pre-dose Day 4 | -6.7 msec | Standard Deviation 8.4 |
| SAD Group II 30mg | MAD: Change From Baseline in ECG Results by Time Point: QTcF | Change from BL at pre-dose Day 7 | -8.8 msec | Standard Deviation 9.2 |
| SAD Group II 30mg | MAD: Change From Baseline in ECG Results by Time Point: QTcF | Change from BL at pre-dose Day 5 | -5.3 msec | Standard Deviation 7.3 |
| SAD Group II 30mg | MAD: Change From Baseline in ECG Results by Time Point: QTcF | Change from BL at 24h - Day 1 | -4.8 msec | Standard Deviation 3.7 |
| SAD Group II 30mg | MAD: Change From Baseline in ECG Results by Time Point: QTcF | Change from BL at 2h - Day 1 | 1.7 msec | Standard Deviation 5.3 |
| SAD Group II 30mg | MAD: Change From Baseline in ECG Results by Time Point: QTcF | Change from BL at FU | 6.7 msec | Standard Deviation 14.1 |
| SAD Group II 30mg | MAD: Change From Baseline in ECG Results by Time Point: QTcF | Baseline (Pre-dose Day 1) | 393.0 msec | Standard Deviation 18.8 |
Primary
MAD: Change From Baseline in ECG Results by Time Point: QT Interval
The baseline ECG recording consists of a triplicate recording (3 recordings of a least 3 complexes within a 5 minute window) prior to dosing on Day 1. For the evaluation the average of the 3 recordings will be taken as baseline. Other ECG recordings will be singlet (one recording of at least 3 complexes) prior to dosing, or around the expected Cmax on Day 1 or 7 for the multiple- dose part.
Time frame: Baseline (pre-dose Day 1), Day1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Follow-up
Population: Per protocol set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group I Placebo | MAD: Change From Baseline in ECG Results by Time Point: QT Interval | Baseline (Pre-dose Day 1) | 410.5 msec | Standard Deviation 41.8 |
| Group I Placebo | MAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from BL at pre-dose Day 4 | -6.0 msec | Standard Deviation 26.1 |
| Group I Placebo | MAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from BL at pre-dose Day 3 | -10.5 msec | Standard Deviation 20 |
| Group I Placebo | MAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from pre-dose Day 7 at 2h - Day 7 | 0.0 msec | Standard Deviation 6.5 |
| Group I Placebo | MAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from BL at pre-dose Day 2 | -10.0 msec | Standard Deviation 11.9 |
| Group I Placebo | MAD: Change From Baseline in ECG Results by Time Point: QT Interval | Baseline (pre-dose Day 7) | 393.0 msec | Standard Deviation 42.6 |
| Group I Placebo | MAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from BL at pre-dose Day 6 | -16.0 msec | Standard Deviation 23.5 |
| Group I Placebo | MAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from pre-dose Day 7 at 4h | -7.0 msec | Standard Deviation 1.2 |
| Group I Placebo | MAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from pre-dose Day 7 at 12h - Day 7 | -20.0 msec | Standard Deviation 14.1 |
| Group I Placebo | MAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from BL at FU | -22.0 msec | Standard Deviation 13.2 |
| Group I Placebo | MAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from BL at 2h - Day 1 | -5.5 msec | Standard Deviation 10.5 |
| Group I Placebo | MAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from pre-dose Day 7 BL at 6h - Day 7 | -15.5 msec | Standard Deviation 14.2 |
| Group I Placebo | MAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from BL at pre-dose Day 7 | -17.5 msec | Standard Deviation 32.3 |
| Group I Placebo | MAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from BL at 24h - Day 1 | -10.0 msec | Standard Deviation 11.9 |
| Group I Placebo | MAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from BL at pre-dose Day 5 | -9.0 msec | Standard Deviation 24.9 |
| Group I Placebo | MAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from pre-dose Day 7 at 8h - Day 7 | -18.5 msec | Standard Deviation 13.7 |
| Group I Placebo | MAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from pre-dose Day 7 at 1h - Day 7 | 5.0 msec | Standard Deviation 12.4 |
| Group II Placebo | MAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from pre-dose Day 7 at 8h - Day 7 | -1.0 msec | Standard Deviation 12.7 |
| Group II Placebo | MAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from BL at pre-dose Day 4 | -3.5 msec | Standard Deviation 13.4 |
| Group II Placebo | MAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from pre-dose Day 7 at 12h - Day 7 | -20.0 msec | Standard Deviation 6.3 |
| Group II Placebo | MAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from BL at FU | -10.5 msec | Standard Deviation 14.6 |
| Group II Placebo | MAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from BL at pre-dose Day 2 | 1.0 msec | Standard Deviation 8.8 |
| Group II Placebo | MAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from BL at pre-dose Day 3 | 7.5 msec | Standard Deviation 6.6 |
| Group II Placebo | MAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from BL at pre-dose Day 7 | -3.0 msec | Standard Deviation 14.8 |
| Group II Placebo | MAD: Change From Baseline in ECG Results by Time Point: QT Interval | Baseline (pre-dose Day 7) | 388.5 msec | Standard Deviation 20.6 |
| Group II Placebo | MAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from pre-dose Day 7 at 1h - Day 7 | -1.0 msec | Standard Deviation 7.4 |
| Group II Placebo | MAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from BL at 2h - Day 1 | -7.5 msec | Standard Deviation 16 |
| Group II Placebo | MAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from BL at pre-dose Day 6 | -0.5 msec | Standard Deviation 12.2 |
| Group II Placebo | MAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from pre-dose Day 7 at 2h - Day 7 | -10.5 msec | Standard Deviation 15.4 |
| Group II Placebo | MAD: Change From Baseline in ECG Results by Time Point: QT Interval | Baseline (Pre-dose Day 1) | 391.5 msec | Standard Deviation 8.5 |
| Group II Placebo | MAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from pre-dose Day 7 at 4h | -2.0 msec | Standard Deviation 7.1 |
| Group II Placebo | MAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from BL at pre-dose Day 5 | -13.0 msec | Standard Deviation 11.9 |
| Group II Placebo | MAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from pre-dose Day 7 BL at 6h - Day 7 | -17.0 msec | Standard Deviation 15.2 |
| Group II Placebo | MAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from BL at 24h - Day 1 | 1.0 msec | Standard Deviation 8.8 |
| SAD Group I 10mg | MAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from BL at pre-dose Day 2 | -14.5 msec | Standard Deviation 4.8 |
| SAD Group I 10mg | MAD: Change From Baseline in ECG Results by Time Point: QT Interval | Baseline (Pre-dose Day 1) | 399.0 msec | Standard Deviation 11.2 |
| SAD Group I 10mg | MAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from BL at 2h - Day 1 | -4.0 msec | Standard Deviation 3.7 |
| SAD Group I 10mg | MAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from BL at 24h - Day 1 | -14.5 msec | Standard Deviation 4.8 |
| SAD Group I 10mg | MAD: Change From Baseline in ECG Results by Time Point: QT Interval | Baseline (pre-dose Day 7) | 402.0 msec | Standard Deviation 18.8 |
| SAD Group I 10mg | MAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from pre-dose Day 7 at 1h - Day 7 | 0.0 msec | Standard Deviation 9.1 |
| SAD Group I 10mg | MAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from pre-dose Day 7 at 2h - Day 7 | -7.5 msec | Standard Deviation 10 |
| SAD Group I 10mg | MAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from pre-dose Day 7 at 4h | -4.0 msec | Standard Deviation 11.9 |
| SAD Group I 10mg | MAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from pre-dose Day 7 BL at 6h - Day 7 | -16.5 msec | Standard Deviation 10.6 |
| SAD Group I 10mg | MAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from pre-dose Day 7 at 8h - Day 7 | -11.0 msec | Standard Deviation 11.9 |
| SAD Group I 10mg | MAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from pre-dose Day 7 at 12h - Day 7 | -11.5 msec | Standard Deviation 9.6 |
| SAD Group I 10mg | MAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from BL at pre-dose Day 3 | -10.0 msec | Standard Deviation 9.6 |
| SAD Group I 10mg | MAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from BL at pre-dose Day 4 | 6.0 msec | Standard Deviation 4.5 |
| SAD Group I 10mg | MAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from BL at pre-dose Day 5 | 3.0 msec | Standard Deviation 9.4 |
| SAD Group I 10mg | MAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from BL at pre-dose Day 6 | -4.5 msec | Standard Deviation 10.1 |
| SAD Group I 10mg | MAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from BL at pre-dose Day 7 | 3.0 msec | Standard Deviation 9.4 |
| SAD Group I 10mg | MAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from BL at FU | -23.0 msec | Standard Deviation 14.3 |
| SAD Group II 30mg | MAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from BL at pre-dose Day 4 | -0.2 msec | Standard Deviation 20.7 |
| SAD Group II 30mg | MAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from pre-dose Day 7 BL at 6h - Day 7 | -14.3 msec | Standard Deviation 26.8 |
| SAD Group II 30mg | MAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from pre-dose Day 7 at 4h | 10.7 msec | Standard Deviation 15.9 |
| SAD Group II 30mg | MAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from BL at 2h - Day 1 | 4.2 msec | Standard Deviation 10.1 |
| SAD Group II 30mg | MAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from BL at pre-dose Day 5 | 1.2 msec | Standard Deviation 16.1 |
| SAD Group II 30mg | MAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from pre-dose Day 7 at 2h - Day 7 | -2.3 msec | Standard Deviation 14.2 |
| SAD Group II 30mg | MAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from pre-dose Day 7 at 1h - Day 7 | 1.0 msec | Standard Deviation 8.1 |
| SAD Group II 30mg | MAD: Change From Baseline in ECG Results by Time Point: QT Interval | Baseline (Pre-dose Day 1) | 410.2 msec | Standard Deviation 33 |
| SAD Group II 30mg | MAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from BL at pre-dose Day 6 | -3.8 msec | Standard Deviation 11.9 |
| SAD Group II 30mg | MAD: Change From Baseline in ECG Results by Time Point: QT Interval | Baseline (pre-dose Day 7) | 406.0 msec | Standard Deviation 22.9 |
| SAD Group II 30mg | MAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from BL at 24h - Day 1 | -4.2 msec | Standard Deviation 14.6 |
| SAD Group II 30mg | MAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from BL at pre-dose Day 2 | -4.2 msec | Standard Deviation 14.6 |
| SAD Group II 30mg | MAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from BL at FU | 13.2 msec | Standard Deviation 23.9 |
| SAD Group II 30mg | MAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from BL at pre-dose Day 3 | -6.2 msec | Standard Deviation 12.6 |
| SAD Group II 30mg | MAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from pre-dose Day 7 at 12h - Day 7 | -8.7 msec | Standard Deviation 19.9 |
| SAD Group II 30mg | MAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from pre-dose Day 7 at 8h - Day 7 | -3.0 msec | Standard Deviation 17.9 |
| SAD Group II 30mg | MAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from BL at pre-dose Day 7 | -4.2 msec | Standard Deviation 16.1 |
Primary
MAD: Change From Baseline in ECG Results by Time Point: the Interval That Denotes Depolarization of the Ventricles, Between the Beginning of the Q Wave and the End of the S Wave (QRS Interval)
The baseline ECG recording consists of a triplicate recording (3 recordings of a least 3 complexes within a 5 minute window) prior to dosing on Day 1. For the evaluation the average of the 3 recordings will be taken as baseline. Other ECG recordings will be singlet (one recording of at least 3 complexes) prior to dosing, or around the expected Cmax on Day 1 or 7 for the multiple- dose part.
Time frame: Baseline (pre-dose Day 1), Day1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Follow-up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group I Placebo | MAD: Change From Baseline in ECG Results by Time Point: the Interval That Denotes Depolarization of the Ventricles, Between the Beginning of the Q Wave and the End of the S Wave (QRS Interval) | Change from BL Day 7 at 8h - Day 7 | -3.5 msec | Standard Deviation 1.9 |
| Group I Placebo | MAD: Change From Baseline in ECG Results by Time Point: the Interval That Denotes Depolarization of the Ventricles, Between the Beginning of the Q Wave and the End of the S Wave (QRS Interval) | Change from BL Day 7 at 12h - Day 7 | -1.5 msec | Standard Deviation 3 |
| Group I Placebo | MAD: Change From Baseline in ECG Results by Time Point: the Interval That Denotes Depolarization of the Ventricles, Between the Beginning of the Q Wave and the End of the S Wave (QRS Interval) | Change from BL at 24h - Day 1 | 0.3 msec | Standard Deviation 2.1 |
| Group I Placebo | MAD: Change From Baseline in ECG Results by Time Point: the Interval That Denotes Depolarization of the Ventricles, Between the Beginning of the Q Wave and the End of the S Wave (QRS Interval) | Change from BL at pre-dose Day 4 | -0.8 msec | Standard Deviation 1.5 |
| Group I Placebo | MAD: Change From Baseline in ECG Results by Time Point: the Interval That Denotes Depolarization of the Ventricles, Between the Beginning of the Q Wave and the End of the S Wave (QRS Interval) | Change from BL at pre-dose Day 2 | 0.3 msec | Standard Deviation 2.1 |
| Group I Placebo | MAD: Change From Baseline in ECG Results by Time Point: the Interval That Denotes Depolarization of the Ventricles, Between the Beginning of the Q Wave and the End of the S Wave (QRS Interval) | Change from BL at pre-dose Day 3 | 0.3 msec | Standard Deviation 2.1 |
| Group I Placebo | MAD: Change From Baseline in ECG Results by Time Point: the Interval That Denotes Depolarization of the Ventricles, Between the Beginning of the Q Wave and the End of the S Wave (QRS Interval) | Change from BL at 2h - Day 1 | 1.3 msec | Standard Deviation 1 |
| Group I Placebo | MAD: Change From Baseline in ECG Results by Time Point: the Interval That Denotes Depolarization of the Ventricles, Between the Beginning of the Q Wave and the End of the S Wave (QRS Interval) | Change from BL Day 7 at 4h | 0.0 msec | Standard Deviation 2.8 |
| Group I Placebo | MAD: Change From Baseline in ECG Results by Time Point: the Interval That Denotes Depolarization of the Ventricles, Between the Beginning of the Q Wave and the End of the S Wave (QRS Interval) | Change from BL at pre-dose Day 7 | 0.3 msec | Standard Deviation 0.5 |
| Group I Placebo | MAD: Change From Baseline in ECG Results by Time Point: the Interval That Denotes Depolarization of the Ventricles, Between the Beginning of the Q Wave and the End of the S Wave (QRS Interval) | Change from BL Day 7 BL at 6h - Day 7 | 0.5 msec | Standard Deviation 1.9 |
| Group I Placebo | MAD: Change From Baseline in ECG Results by Time Point: the Interval That Denotes Depolarization of the Ventricles, Between the Beginning of the Q Wave and the End of the S Wave (QRS Interval) | Baseline (pre-dose Day 7) | 99.5 msec | Standard Deviation 7.2 |
| Group I Placebo | MAD: Change From Baseline in ECG Results by Time Point: the Interval That Denotes Depolarization of the Ventricles, Between the Beginning of the Q Wave and the End of the S Wave (QRS Interval) | Baseline (Pre-dose Day 1) | 99.3 msec | Standard Deviation 6.9 |
| Group I Placebo | MAD: Change From Baseline in ECG Results by Time Point: the Interval That Denotes Depolarization of the Ventricles, Between the Beginning of the Q Wave and the End of the S Wave (QRS Interval) | Change from BL at pre-dose Day 6 | -0.3 msec | Standard Deviation 1.3 |
| Group I Placebo | MAD: Change From Baseline in ECG Results by Time Point: the Interval That Denotes Depolarization of the Ventricles, Between the Beginning of the Q Wave and the End of the S Wave (QRS Interval) | Change from BL Day 7 at 1h - Day 7 | 0.5 msec | Standard Deviation 3 |
| Group I Placebo | MAD: Change From Baseline in ECG Results by Time Point: the Interval That Denotes Depolarization of the Ventricles, Between the Beginning of the Q Wave and the End of the S Wave (QRS Interval) | Change from BL Day 7 at 2h - Day 7 | 0.5 msec | Standard Deviation 1.9 |
| Group I Placebo | MAD: Change From Baseline in ECG Results by Time Point: the Interval That Denotes Depolarization of the Ventricles, Between the Beginning of the Q Wave and the End of the S Wave (QRS Interval) | Change from BL at FU | 0.3 msec | Standard Deviation 2.6 |
| Group I Placebo | MAD: Change From Baseline in ECG Results by Time Point: the Interval That Denotes Depolarization of the Ventricles, Between the Beginning of the Q Wave and the End of the S Wave (QRS Interval) | Change from BL at pre-dose Day 5 | -0.8 msec | Standard Deviation 1.5 |
| Group II Placebo | MAD: Change From Baseline in ECG Results by Time Point: the Interval That Denotes Depolarization of the Ventricles, Between the Beginning of the Q Wave and the End of the S Wave (QRS Interval) | Change from BL at pre-dose Day 5 | 2.5 msec | Standard Deviation 0.6 |
| Group II Placebo | MAD: Change From Baseline in ECG Results by Time Point: the Interval That Denotes Depolarization of the Ventricles, Between the Beginning of the Q Wave and the End of the S Wave (QRS Interval) | Change from BL at pre-dose Day 4 | 5.0 msec | Standard Deviation 3.4 |
| Group II Placebo | MAD: Change From Baseline in ECG Results by Time Point: the Interval That Denotes Depolarization of the Ventricles, Between the Beginning of the Q Wave and the End of the S Wave (QRS Interval) | Change from BL Day 7 at 8h - Day 7 | -0.5 msec | Standard Deviation 1.9 |
| Group II Placebo | MAD: Change From Baseline in ECG Results by Time Point: the Interval That Denotes Depolarization of the Ventricles, Between the Beginning of the Q Wave and the End of the S Wave (QRS Interval) | Change from BL Day 7 at 12h - Day 7 | -2.0 msec | Standard Deviation 1.6 |
| Group II Placebo | MAD: Change From Baseline in ECG Results by Time Point: the Interval That Denotes Depolarization of the Ventricles, Between the Beginning of the Q Wave and the End of the S Wave (QRS Interval) | Change from BL Day 7 BL at 6h - Day 7 | -2.5 msec | Standard Deviation 2.5 |
| Group II Placebo | MAD: Change From Baseline in ECG Results by Time Point: the Interval That Denotes Depolarization of the Ventricles, Between the Beginning of the Q Wave and the End of the S Wave (QRS Interval) | Change from BL Day 7 at 2h - Day 7 | 1.0 msec | Standard Deviation 1.2 |
| Group II Placebo | MAD: Change From Baseline in ECG Results by Time Point: the Interval That Denotes Depolarization of the Ventricles, Between the Beginning of the Q Wave and the End of the S Wave (QRS Interval) | Change from BL at pre-dose Day 6 | 2.0 msec | Standard Deviation 2.4 |
| Group II Placebo | MAD: Change From Baseline in ECG Results by Time Point: the Interval That Denotes Depolarization of the Ventricles, Between the Beginning of the Q Wave and the End of the S Wave (QRS Interval) | Change from BL at pre-dose Day 2 | 2.5 msec | Standard Deviation 2.4 |
| Group II Placebo | MAD: Change From Baseline in ECG Results by Time Point: the Interval That Denotes Depolarization of the Ventricles, Between the Beginning of the Q Wave and the End of the S Wave (QRS Interval) | Change from BL at 24h - Day 1 | 2.5 msec | Standard Deviation 2.4 |
| Group II Placebo | MAD: Change From Baseline in ECG Results by Time Point: the Interval That Denotes Depolarization of the Ventricles, Between the Beginning of the Q Wave and the End of the S Wave (QRS Interval) | Change from BL at pre-dose Day 3 | 2.5 msec | Standard Deviation 1.3 |
| Group II Placebo | MAD: Change From Baseline in ECG Results by Time Point: the Interval That Denotes Depolarization of the Ventricles, Between the Beginning of the Q Wave and the End of the S Wave (QRS Interval) | Change from BL Day 7 at 1h - Day 7 | 0.0 msec | Standard Deviation 2.8 |
| Group II Placebo | MAD: Change From Baseline in ECG Results by Time Point: the Interval That Denotes Depolarization of the Ventricles, Between the Beginning of the Q Wave and the End of the S Wave (QRS Interval) | Baseline (pre-dose Day 7) | 97.0 msec | Standard Deviation 5.3 |
| Group II Placebo | MAD: Change From Baseline in ECG Results by Time Point: the Interval That Denotes Depolarization of the Ventricles, Between the Beginning of the Q Wave and the End of the S Wave (QRS Interval) | Change from BL at 2h - Day 1 | 2.0 msec | Standard Deviation 1.4 |
| Group II Placebo | MAD: Change From Baseline in ECG Results by Time Point: the Interval That Denotes Depolarization of the Ventricles, Between the Beginning of the Q Wave and the End of the S Wave (QRS Interval) | Change from BL at pre-dose Day 7 | 4.5 msec | Standard Deviation 1.3 |
| Group II Placebo | MAD: Change From Baseline in ECG Results by Time Point: the Interval That Denotes Depolarization of the Ventricles, Between the Beginning of the Q Wave and the End of the S Wave (QRS Interval) | Change from BL at FU | 0.5 msec | Standard Deviation 1.7 |
| Group II Placebo | MAD: Change From Baseline in ECG Results by Time Point: the Interval That Denotes Depolarization of the Ventricles, Between the Beginning of the Q Wave and the End of the S Wave (QRS Interval) | Change from BL Day 7 at 4h | -0.5 msec | Standard Deviation 1 |
| Group II Placebo | MAD: Change From Baseline in ECG Results by Time Point: the Interval That Denotes Depolarization of the Ventricles, Between the Beginning of the Q Wave and the End of the S Wave (QRS Interval) | Baseline (Pre-dose Day 1) | 92.5 msec | Standard Deviation 6.1 |
| SAD Group I 10mg | MAD: Change From Baseline in ECG Results by Time Point: the Interval That Denotes Depolarization of the Ventricles, Between the Beginning of the Q Wave and the End of the S Wave (QRS Interval) | Change from BL Day 7 at 4h | 2.5 msec | Standard Deviation 2.5 |
| SAD Group I 10mg | MAD: Change From Baseline in ECG Results by Time Point: the Interval That Denotes Depolarization of the Ventricles, Between the Beginning of the Q Wave and the End of the S Wave (QRS Interval) | Baseline (Pre-dose Day 1) | 85.5 msec | Standard Deviation 8.3 |
| SAD Group I 10mg | MAD: Change From Baseline in ECG Results by Time Point: the Interval That Denotes Depolarization of the Ventricles, Between the Beginning of the Q Wave and the End of the S Wave (QRS Interval) | Change from BL at 2h - Day 1 | 6.0 msec | Standard Deviation 2.9 |
| SAD Group I 10mg | MAD: Change From Baseline in ECG Results by Time Point: the Interval That Denotes Depolarization of the Ventricles, Between the Beginning of the Q Wave and the End of the S Wave (QRS Interval) | Change from BL Day 7 at 2h - Day 7 | 5.5 msec | Standard Deviation 1.9 |
| SAD Group I 10mg | MAD: Change From Baseline in ECG Results by Time Point: the Interval That Denotes Depolarization of the Ventricles, Between the Beginning of the Q Wave and the End of the S Wave (QRS Interval) | Change from BL at 24h - Day 1 | 3.5 msec | Standard Deviation 2.6 |
| SAD Group I 10mg | MAD: Change From Baseline in ECG Results by Time Point: the Interval That Denotes Depolarization of the Ventricles, Between the Beginning of the Q Wave and the End of the S Wave (QRS Interval) | Change from BL Day 7 BL at 6h - Day 7 | 3.0 msec | Standard Deviation 2 |
| SAD Group I 10mg | MAD: Change From Baseline in ECG Results by Time Point: the Interval That Denotes Depolarization of the Ventricles, Between the Beginning of the Q Wave and the End of the S Wave (QRS Interval) | Baseline (pre-dose Day 7) | 87.5 msec | Standard Deviation 7.2 |
| SAD Group I 10mg | MAD: Change From Baseline in ECG Results by Time Point: the Interval That Denotes Depolarization of the Ventricles, Between the Beginning of the Q Wave and the End of the S Wave (QRS Interval) | Change from BL Day 7 at 1h - Day 7 | 5.0 msec | Standard Deviation 2 |
| SAD Group I 10mg | MAD: Change From Baseline in ECG Results by Time Point: the Interval That Denotes Depolarization of the Ventricles, Between the Beginning of the Q Wave and the End of the S Wave (QRS Interval) | Change from BL Day 7 at 8h - Day 7 | 2.0 msec | Standard Deviation 1.6 |
| SAD Group I 10mg | MAD: Change From Baseline in ECG Results by Time Point: the Interval That Denotes Depolarization of the Ventricles, Between the Beginning of the Q Wave and the End of the S Wave (QRS Interval) | Change from BL Day 7 at 12h - Day 7 | 2.0 msec | Standard Deviation 0 |
| SAD Group I 10mg | MAD: Change From Baseline in ECG Results by Time Point: the Interval That Denotes Depolarization of the Ventricles, Between the Beginning of the Q Wave and the End of the S Wave (QRS Interval) | Change from BL at pre-dose Day 2 | 3.5 msec | Standard Deviation 2.6 |
| SAD Group I 10mg | MAD: Change From Baseline in ECG Results by Time Point: the Interval That Denotes Depolarization of the Ventricles, Between the Beginning of the Q Wave and the End of the S Wave (QRS Interval) | Change from BL at pre-dose Day 3 | 2.0 msec | Standard Deviation 3.7 |
| SAD Group I 10mg | MAD: Change From Baseline in ECG Results by Time Point: the Interval That Denotes Depolarization of the Ventricles, Between the Beginning of the Q Wave and the End of the S Wave (QRS Interval) | Change from BL at pre-dose Day 4 | 3.5 msec | Standard Deviation 1.7 |
| SAD Group I 10mg | MAD: Change From Baseline in ECG Results by Time Point: the Interval That Denotes Depolarization of the Ventricles, Between the Beginning of the Q Wave and the End of the S Wave (QRS Interval) | Change from BL at pre-dose Day 5 | 2.5 msec | Standard Deviation 1.7 |
| SAD Group I 10mg | MAD: Change From Baseline in ECG Results by Time Point: the Interval That Denotes Depolarization of the Ventricles, Between the Beginning of the Q Wave and the End of the S Wave (QRS Interval) | Change from BL at pre-dose Day 6 | 1.0 msec | Standard Deviation 2.2 |
| SAD Group I 10mg | MAD: Change From Baseline in ECG Results by Time Point: the Interval That Denotes Depolarization of the Ventricles, Between the Beginning of the Q Wave and the End of the S Wave (QRS Interval) | Change from BL at pre-dose Day 7 | 2.0 msec | Standard Deviation 1.4 |
| SAD Group I 10mg | MAD: Change From Baseline in ECG Results by Time Point: the Interval That Denotes Depolarization of the Ventricles, Between the Beginning of the Q Wave and the End of the S Wave (QRS Interval) | Change from BL at FU | -2.5 msec | Standard Deviation 2.4 |
| SAD Group II 30mg | MAD: Change From Baseline in ECG Results by Time Point: the Interval That Denotes Depolarization of the Ventricles, Between the Beginning of the Q Wave and the End of the S Wave (QRS Interval) | Change from BL at pre-dose Day 4 | -0.5 msec | Standard Deviation 2.7 |
| SAD Group II 30mg | MAD: Change From Baseline in ECG Results by Time Point: the Interval That Denotes Depolarization of the Ventricles, Between the Beginning of the Q Wave and the End of the S Wave (QRS Interval) | Change from BL Day 7 BL at 6h - Day 7 | 0.7 msec | Standard Deviation 2.4 |
| SAD Group II 30mg | MAD: Change From Baseline in ECG Results by Time Point: the Interval That Denotes Depolarization of the Ventricles, Between the Beginning of the Q Wave and the End of the S Wave (QRS Interval) | Change from BL Day 7 at 1h - Day 7 | -0.3 msec | Standard Deviation 0.8 |
| SAD Group II 30mg | MAD: Change From Baseline in ECG Results by Time Point: the Interval That Denotes Depolarization of the Ventricles, Between the Beginning of the Q Wave and the End of the S Wave (QRS Interval) | Change from BL at 2h - Day 1 | -0.2 msec | Standard Deviation 1.8 |
| SAD Group II 30mg | MAD: Change From Baseline in ECG Results by Time Point: the Interval That Denotes Depolarization of the Ventricles, Between the Beginning of the Q Wave and the End of the S Wave (QRS Interval) | Change from BL at pre-dose Day 5 | -0.5 msec | Standard Deviation 2.7 |
| SAD Group II 30mg | MAD: Change From Baseline in ECG Results by Time Point: the Interval That Denotes Depolarization of the Ventricles, Between the Beginning of the Q Wave and the End of the S Wave (QRS Interval) | Baseline (pre-dose Day 7) | 98.7 msec | Standard Deviation 8.8 |
| SAD Group II 30mg | MAD: Change From Baseline in ECG Results by Time Point: the Interval That Denotes Depolarization of the Ventricles, Between the Beginning of the Q Wave and the End of the S Wave (QRS Interval) | Change from BL at 24h - Day 1 | -0.8 msec | Standard Deviation 1.3 |
| SAD Group II 30mg | MAD: Change From Baseline in ECG Results by Time Point: the Interval That Denotes Depolarization of the Ventricles, Between the Beginning of the Q Wave and the End of the S Wave (QRS Interval) | Baseline (Pre-dose Day 1) | 98.5 msec | Standard Deviation 8.2 |
| SAD Group II 30mg | MAD: Change From Baseline in ECG Results by Time Point: the Interval That Denotes Depolarization of the Ventricles, Between the Beginning of the Q Wave and the End of the S Wave (QRS Interval) | Change from BL at pre-dose Day 6 | -1.8 msec | Standard Deviation 2 |
| SAD Group II 30mg | MAD: Change From Baseline in ECG Results by Time Point: the Interval That Denotes Depolarization of the Ventricles, Between the Beginning of the Q Wave and the End of the S Wave (QRS Interval) | Change from BL Day 7 at 4h | 0.7 msec | Standard Deviation 3 |
| SAD Group II 30mg | MAD: Change From Baseline in ECG Results by Time Point: the Interval That Denotes Depolarization of the Ventricles, Between the Beginning of the Q Wave and the End of the S Wave (QRS Interval) | Change from BL Day 7 at 2h - Day 7 | 0.7 msec | Standard Deviation 2.4 |
| SAD Group II 30mg | MAD: Change From Baseline in ECG Results by Time Point: the Interval That Denotes Depolarization of the Ventricles, Between the Beginning of the Q Wave and the End of the S Wave (QRS Interval) | Change from BL at pre-dose Day 2 | -0.8 msec | Standard Deviation 1.3 |
| SAD Group II 30mg | MAD: Change From Baseline in ECG Results by Time Point: the Interval That Denotes Depolarization of the Ventricles, Between the Beginning of the Q Wave and the End of the S Wave (QRS Interval) | Change from BL at FU | -1.8 msec | Standard Deviation 5.2 |
| SAD Group II 30mg | MAD: Change From Baseline in ECG Results by Time Point: the Interval That Denotes Depolarization of the Ventricles, Between the Beginning of the Q Wave and the End of the S Wave (QRS Interval) | Change from BL at pre-dose Day 3 | -0.8 msec | Standard Deviation 2.4 |
| SAD Group II 30mg | MAD: Change From Baseline in ECG Results by Time Point: the Interval That Denotes Depolarization of the Ventricles, Between the Beginning of the Q Wave and the End of the S Wave (QRS Interval) | Change from BL Day 7 at 12h - Day 7 | -2.0 msec | Standard Deviation 3.6 |
| SAD Group II 30mg | MAD: Change From Baseline in ECG Results by Time Point: the Interval That Denotes Depolarization of the Ventricles, Between the Beginning of the Q Wave and the End of the S Wave (QRS Interval) | Change from BL Day 7 at 8h - Day 7 | 0.7 msec | Standard Deviation 4.8 |
| SAD Group II 30mg | MAD: Change From Baseline in ECG Results by Time Point: the Interval That Denotes Depolarization of the Ventricles, Between the Beginning of the Q Wave and the End of the S Wave (QRS Interval) | Change from BL at pre-dose Day 7 | 0.2 msec | Standard Deviation 3.1 |
Primary
Maximum Concentration (Cmax) of KH176: MAD
Plasma concentrations of KH176 were analysed after multiple-dose administration of doses of 100, 200 and 400 mg b.i.d.
Time frame: pre-dose at Day 1, 2, 4, 7, and post-dose at Day 1 and Day 7 at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours
Population: Per protocol set
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Group I Placebo | Maximum Concentration (Cmax) of KH176: MAD | Day 1 | 184 ng/mL | Geometric Coefficient of Variation 57 |
| Group I Placebo | Maximum Concentration (Cmax) of KH176: MAD | Day 7 | 353 ng/mL | Geometric Coefficient of Variation 19.1 |
| Group II Placebo | Maximum Concentration (Cmax) of KH176: MAD | Day 1 | 313 ng/mL | Geometric Coefficient of Variation 20 |
| Group II Placebo | Maximum Concentration (Cmax) of KH176: MAD | Day 7 | 748 ng/mL | Geometric Coefficient of Variation 29.3 |
| SAD Group I 10mg | Maximum Concentration (Cmax) of KH176: MAD | Day 1 | 1330 ng/mL | Geometric Coefficient of Variation 27.3 |
| SAD Group I 10mg | Maximum Concentration (Cmax) of KH176: MAD | Day 7 | 2100 ng/mL | Geometric Coefficient of Variation 27.2 |
Primary
Maximum Concentration (Cmax) of KH176: SAD Group
Plasma concentrations of KH176 were analysed after single dose administration of doses 10mg, 30mg, 100mg (with and without food), 300mg, 800mg, 2000mg b.i.d.
Time frame: Pre-dose (5 min before dosing) and 0.5, 1, 1.5, 2, 3, 6, 8, 12, and 24 hours post-dose
Population: Per protocol set
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Group I Placebo | Maximum Concentration (Cmax) of KH176: SAD Group | 12.9 ng/mL | Geometric Coefficient of Variation 21.3 |
| Group II Placebo | Maximum Concentration (Cmax) of KH176: SAD Group | 56.2 ng/mL | Geometric Coefficient of Variation 21 |
| SAD Group I 10mg | Maximum Concentration (Cmax) of KH176: SAD Group | 167 ng/mL | Geometric Coefficient of Variation 27.2 |
| SAD Group II 30mg | Maximum Concentration (Cmax) of KH176: SAD Group | 766 ng/mL | Geometric Coefficient of Variation 53.9 |
| SAD Group I 100mg | Maximum Concentration (Cmax) of KH176: SAD Group | 2170 ng/mL | Geometric Coefficient of Variation 27.9 |
| SAD Group II 300mg | Maximum Concentration (Cmax) of KH176: SAD Group | 5990 ng/mL | Geometric Coefficient of Variation 20.9 |
| SAD Group I 800mg | Maximum Concentration (Cmax) of KH176: SAD Group | 165 ng/mL | Geometric Coefficient of Variation 7.4 |
Primary
Maximum Concentration (Cmax) of KH183 (Active Metabolite of KH176): MAD Group
Plasma concentrations of KH183 were analysed after multiple-dose administration of doses of 100, 200 and 400 mg b.i.d.: Cmax was obtained directly from the concentration-time data.
Time frame: Predose at Day 1, 2, 4, 7, and post-dose at Day 1 and Day 7 at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours
Population: Per protocol set
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Group I Placebo | Maximum Concentration (Cmax) of KH183 (Active Metabolite of KH176): MAD Group | Day 1 | 99.4 ng/mL | Geometric Coefficient of Variation 20.9 |
| Group I Placebo | Maximum Concentration (Cmax) of KH183 (Active Metabolite of KH176): MAD Group | Day 7 | 152 ng/mL | Geometric Coefficient of Variation 37.5 |
| Group II Placebo | Maximum Concentration (Cmax) of KH183 (Active Metabolite of KH176): MAD Group | Day 1 | 251 ng/mL | Geometric Coefficient of Variation 18 |
| Group II Placebo | Maximum Concentration (Cmax) of KH183 (Active Metabolite of KH176): MAD Group | Day 7 | 250 ng/mL | Geometric Coefficient of Variation 10.6 |
| SAD Group I 10mg | Maximum Concentration (Cmax) of KH183 (Active Metabolite of KH176): MAD Group | Day 1 | 550 ng/mL | Geometric Coefficient of Variation 14.1 |
| SAD Group I 10mg | Maximum Concentration (Cmax) of KH183 (Active Metabolite of KH176): MAD Group | Day 7 | 450 ng/mL | Geometric Coefficient of Variation 28.3 |
Primary
Maximum Concentration (Cmax) of KH183 Over 24 Hours: SAD
Plasma concentrations of KH183 were analysed after single dose administration of doses 10mg, 30mg, 100mg (with and without food) , 300mg, 800mg, 2000mg b.i.d.
Time frame: Pre-dose (5 min before dosing) and 0.5, 1, 1.5, 2, 3, 6, 8, 12, and 24 hours post-dose
Population: Per protocol set
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Group I Placebo | Maximum Concentration (Cmax) of KH183 Over 24 Hours: SAD | 14.2 ng/mL | Geometric Coefficient of Variation 49.5 |
| Group II Placebo | Maximum Concentration (Cmax) of KH183 Over 24 Hours: SAD | 49.4 ng/mL | Geometric Coefficient of Variation 9 |
| SAD Group I 10mg | Maximum Concentration (Cmax) of KH183 Over 24 Hours: SAD | 168 ng/mL | Geometric Coefficient of Variation 29.6 |
| SAD Group II 30mg | Maximum Concentration (Cmax) of KH183 Over 24 Hours: SAD | 497 ng/mL | Geometric Coefficient of Variation 17.6 |
| SAD Group I 100mg | Maximum Concentration (Cmax) of KH183 Over 24 Hours: SAD | 1100 ng/mL | Geometric Coefficient of Variation 9.58 |
| SAD Group II 300mg | Maximum Concentration (Cmax) of KH183 Over 24 Hours: SAD | 1780 ng/mL | Geometric Coefficient of Variation 26.3 |
| SAD Group I 800mg | Maximum Concentration (Cmax) of KH183 Over 24 Hours: SAD | 117 ng/mL | Geometric Coefficient of Variation 20 |
Primary
Pharmacodynamics of KH176
Change from baseline in biochemistry related to Oxidative Phosphorylation (OXPHOS) (glutathione, lactate); MAD group
Time frame: Day 1, day 7
Population: Per protocol set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group I Placebo | Pharmacodynamics of KH176 | Ox glutathione (GSH)/Red Glutathati(GSSG) Day 1-0h | 872 ratio GSH/GSSG | Standard Deviation 532 |
| Group I Placebo | Pharmacodynamics of KH176 | GSH/GSSG Day 7-0h | 919 ratio GSH/GSSG | Standard Deviation 196 |
| Group I Placebo | Pharmacodynamics of KH176 | GSH/GSSG Day 7-3h | 779 ratio GSH/GSSG | Standard Deviation 87 |
| Group I Placebo | Pharmacodynamics of KH176 | GSH/GSSG Day 7-6h | 1040 ratio GSH/GSSG | Standard Deviation 335 |
| Group I Placebo | Pharmacodynamics of KH176 | GSH/GSSG Day 7-12h | 1361 ratio GSH/GSSG | Standard Deviation 606 |
| Group II Placebo | Pharmacodynamics of KH176 | GSH/GSSG Day 7-12h | 1893 ratio GSH/GSSG | Standard Deviation 279 |
| Group II Placebo | Pharmacodynamics of KH176 | GSH/GSSG Day 7-3h | 2045 ratio GSH/GSSG | Standard Deviation 338 |
| Group II Placebo | Pharmacodynamics of KH176 | GSH/GSSG Day 7-0h | 1923 ratio GSH/GSSG | Standard Deviation 433 |
| Group II Placebo | Pharmacodynamics of KH176 | Ox glutathione (GSH)/Red Glutathati(GSSG) Day 1-0h | 2083 ratio GSH/GSSG | Standard Deviation 674 |
| Group II Placebo | Pharmacodynamics of KH176 | GSH/GSSG Day 7-6h | 2113 ratio GSH/GSSG | Standard Deviation 687 |
| SAD Group I 10mg | Pharmacodynamics of KH176 | GSH/GSSG Day 7-6h | 1993 ratio GSH/GSSG | Standard Deviation 863 |
| SAD Group I 10mg | Pharmacodynamics of KH176 | GSH/GSSG Day 7-0h | 1918 ratio GSH/GSSG | Standard Deviation 1007 |
| SAD Group I 10mg | Pharmacodynamics of KH176 | GSH/GSSG Day 7-3h | 1935 ratio GSH/GSSG | Standard Deviation 699 |
| SAD Group I 10mg | Pharmacodynamics of KH176 | Ox glutathione (GSH)/Red Glutathati(GSSG) Day 1-0h | 2275 ratio GSH/GSSG | Standard Deviation 792 |
| SAD Group I 10mg | Pharmacodynamics of KH176 | GSH/GSSG Day 7-12h | 1875 ratio GSH/GSSG | Standard Deviation 697 |
| SAD Group II 30mg | Pharmacodynamics of KH176 | GSH/GSSG Day 7-0h | 1694 ratio GSH/GSSG | Standard Deviation 572 |
| SAD Group II 30mg | Pharmacodynamics of KH176 | GSH/GSSG Day 7-12h | 1680 ratio GSH/GSSG | Standard Deviation 657 |
| SAD Group II 30mg | Pharmacodynamics of KH176 | Ox glutathione (GSH)/Red Glutathati(GSSG) Day 1-0h | 1584 ratio GSH/GSSG | Standard Deviation 491 |
| SAD Group II 30mg | Pharmacodynamics of KH176 | GSH/GSSG Day 7-3h | 1712 ratio GSH/GSSG | Standard Deviation 465 |
| SAD Group II 30mg | Pharmacodynamics of KH176 | GSH/GSSG Day 7-6h | 1718 ratio GSH/GSSG | Standard Deviation 542 |
Primary
Phospholipidosis
Change from Day 1 to Day 7 in di-docosahexaenoyl (22:6)-bis(monoacylglycerol) phosphate (di-22:6-BMP) and normalized di-22:6-BMP (urine) - MAD
Time frame: Day 1, Day 7
Population: Per protocol set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group I Placebo | Phospholipidosis | di-22:6-BMP: Change from Day 1 to Day 7 | -1.473 ng/mL | Standard Deviation 4.52 |
| Group I Placebo | Phospholipidosis | Normalized di-22:6-BMP: Change from Day 1 to Day 7 | 1.298 ng/mL | Standard Deviation 0.819 |
| Group II Placebo | Phospholipidosis | Normalized di-22:6-BMP: Change from Day 1 to Day 7 | 0.060 ng/mL | Standard Deviation 1.152 |
| Group II Placebo | Phospholipidosis | di-22:6-BMP: Change from Day 1 to Day 7 | -3.465 ng/mL | Standard Deviation 4.87 |
| SAD Group I 10mg | Phospholipidosis | Normalized di-22:6-BMP: Change from Day 1 to Day 7 | 0.337 ng/mL | Standard Deviation 1.12 |
| SAD Group I 10mg | Phospholipidosis | di-22:6-BMP: Change from Day 1 to Day 7 | -2.630 ng/mL | Standard Deviation 2.633 |
| SAD Group II 30mg | Phospholipidosis | di-22:6-BMP: Change from Day 1 to Day 7 | -1.592 ng/mL | Standard Deviation 3.283 |
| SAD Group II 30mg | Phospholipidosis | Normalized di-22:6-BMP: Change from Day 1 to Day 7 | 1.780 ng/mL | Standard Deviation 1.874 |
Primary
Relationship to Study Drug and Severity of Treatment-emergent Adverse Events
Time frame: 4 months
Population: The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group I Placebo | Relationship to Study Drug and Severity of Treatment-emergent Adverse Events | Serious TEAE | 0 TEAE |
| Group I Placebo | Relationship to Study Drug and Severity of Treatment-emergent Adverse Events | Possibly related | 1 TEAE |
| Group I Placebo | Relationship to Study Drug and Severity of Treatment-emergent Adverse Events | Related | 0 TEAE |
| Group I Placebo | Relationship to Study Drug and Severity of Treatment-emergent Adverse Events | TEAE | 5 TEAE |
| Group I Placebo | Relationship to Study Drug and Severity of Treatment-emergent Adverse Events | Not related TEAE | 4 TEAE |
| Group I Placebo | Relationship to Study Drug and Severity of Treatment-emergent Adverse Events | Unlikely related | 0 TEAE |
| Group II Placebo | Relationship to Study Drug and Severity of Treatment-emergent Adverse Events | TEAE | 2 TEAE |
| Group II Placebo | Relationship to Study Drug and Severity of Treatment-emergent Adverse Events | Related | 0 TEAE |
| Group II Placebo | Relationship to Study Drug and Severity of Treatment-emergent Adverse Events | Unlikely related | 2 TEAE |
| Group II Placebo | Relationship to Study Drug and Severity of Treatment-emergent Adverse Events | Serious TEAE | 0 TEAE |
| Group II Placebo | Relationship to Study Drug and Severity of Treatment-emergent Adverse Events | Possibly related | 0 TEAE |
| Group II Placebo | Relationship to Study Drug and Severity of Treatment-emergent Adverse Events | Not related TEAE | 0 TEAE |
| SAD Group I 10mg | Relationship to Study Drug and Severity of Treatment-emergent Adverse Events | Serious TEAE | 0 TEAE |
| SAD Group I 10mg | Relationship to Study Drug and Severity of Treatment-emergent Adverse Events | Related | 0 TEAE |
| SAD Group I 10mg | Relationship to Study Drug and Severity of Treatment-emergent Adverse Events | Not related TEAE | 0 TEAE |
| SAD Group I 10mg | Relationship to Study Drug and Severity of Treatment-emergent Adverse Events | Possibly related | 0 TEAE |
| SAD Group I 10mg | Relationship to Study Drug and Severity of Treatment-emergent Adverse Events | TEAE | 2 TEAE |
| SAD Group I 10mg | Relationship to Study Drug and Severity of Treatment-emergent Adverse Events | Unlikely related | 2 TEAE |
| SAD Group II 30mg | Relationship to Study Drug and Severity of Treatment-emergent Adverse Events | Related | 0 TEAE |
| SAD Group II 30mg | Relationship to Study Drug and Severity of Treatment-emergent Adverse Events | Unlikely related | 3 TEAE |
| SAD Group II 30mg | Relationship to Study Drug and Severity of Treatment-emergent Adverse Events | Possibly related | 0 TEAE |
| SAD Group II 30mg | Relationship to Study Drug and Severity of Treatment-emergent Adverse Events | Serious TEAE | 0 TEAE |
| SAD Group II 30mg | Relationship to Study Drug and Severity of Treatment-emergent Adverse Events | TEAE | 5 TEAE |
| SAD Group II 30mg | Relationship to Study Drug and Severity of Treatment-emergent Adverse Events | Not related TEAE | 2 TEAE |
| SAD Group I 100mg | Relationship to Study Drug and Severity of Treatment-emergent Adverse Events | Possibly related | 1 TEAE |
| SAD Group I 100mg | Relationship to Study Drug and Severity of Treatment-emergent Adverse Events | Not related TEAE | 6 TEAE |
| SAD Group I 100mg | Relationship to Study Drug and Severity of Treatment-emergent Adverse Events | Serious TEAE | 0 TEAE |
| SAD Group I 100mg | Relationship to Study Drug and Severity of Treatment-emergent Adverse Events | TEAE | 7 TEAE |
| SAD Group I 100mg | Relationship to Study Drug and Severity of Treatment-emergent Adverse Events | Unlikely related | 0 TEAE |
| SAD Group I 100mg | Relationship to Study Drug and Severity of Treatment-emergent Adverse Events | Related | 0 TEAE |
| SAD Group II 300mg | Relationship to Study Drug and Severity of Treatment-emergent Adverse Events | Related | 1 TEAE |
| SAD Group II 300mg | Relationship to Study Drug and Severity of Treatment-emergent Adverse Events | Unlikely related | 0 TEAE |
| SAD Group II 300mg | Relationship to Study Drug and Severity of Treatment-emergent Adverse Events | Not related TEAE | 0 TEAE |
| SAD Group II 300mg | Relationship to Study Drug and Severity of Treatment-emergent Adverse Events | Possibly related | 0 TEAE |
| SAD Group II 300mg | Relationship to Study Drug and Severity of Treatment-emergent Adverse Events | TEAE | 1 TEAE |
| SAD Group II 300mg | Relationship to Study Drug and Severity of Treatment-emergent Adverse Events | Serious TEAE | 0 TEAE |
| SAD Group I 800mg | Relationship to Study Drug and Severity of Treatment-emergent Adverse Events | Possibly related | 0 TEAE |
| SAD Group I 800mg | Relationship to Study Drug and Severity of Treatment-emergent Adverse Events | TEAE | 0 TEAE |
| SAD Group I 800mg | Relationship to Study Drug and Severity of Treatment-emergent Adverse Events | Unlikely related | 0 TEAE |
| SAD Group I 800mg | Relationship to Study Drug and Severity of Treatment-emergent Adverse Events | Related | 0 TEAE |
| SAD Group I 800mg | Relationship to Study Drug and Severity of Treatment-emergent Adverse Events | Serious TEAE | 0 TEAE |
| SAD Group I 800mg | Relationship to Study Drug and Severity of Treatment-emergent Adverse Events | Not related TEAE | 0 TEAE |
| SAD Group II 2000mg | Relationship to Study Drug and Severity of Treatment-emergent Adverse Events | Related | 25 TEAE |
| SAD Group II 2000mg | Relationship to Study Drug and Severity of Treatment-emergent Adverse Events | Serious TEAE | 0 TEAE |
| SAD Group II 2000mg | Relationship to Study Drug and Severity of Treatment-emergent Adverse Events | Possibly related | 3 TEAE |
| SAD Group II 2000mg | Relationship to Study Drug and Severity of Treatment-emergent Adverse Events | TEAE | 28 TEAE |
| SAD Group II 2000mg | Relationship to Study Drug and Severity of Treatment-emergent Adverse Events | Not related TEAE | 0 TEAE |
| SAD Group II 2000mg | Relationship to Study Drug and Severity of Treatment-emergent Adverse Events | Unlikely related | 0 TEAE |
| Group I Placebo + Food | Relationship to Study Drug and Severity of Treatment-emergent Adverse Events | Possibly related | 0 TEAE |
| Group I Placebo + Food | Relationship to Study Drug and Severity of Treatment-emergent Adverse Events | TEAE | 1 TEAE |
| Group I Placebo + Food | Relationship to Study Drug and Severity of Treatment-emergent Adverse Events | Related | 0 TEAE |
| Group I Placebo + Food | Relationship to Study Drug and Severity of Treatment-emergent Adverse Events | Unlikely related | 0 TEAE |
| Group I Placebo + Food | Relationship to Study Drug and Severity of Treatment-emergent Adverse Events | Not related TEAE | 1 TEAE |
| Group I Placebo + Food | Relationship to Study Drug and Severity of Treatment-emergent Adverse Events | Serious TEAE | 0 TEAE |
| Group I 100mg + Food | Relationship to Study Drug and Severity of Treatment-emergent Adverse Events | Not related TEAE | 1 TEAE |
| Group I 100mg + Food | Relationship to Study Drug and Severity of Treatment-emergent Adverse Events | Serious TEAE | 0 TEAE |
| Group I 100mg + Food | Relationship to Study Drug and Severity of Treatment-emergent Adverse Events | Possibly related | 0 TEAE |
| Group I 100mg + Food | Relationship to Study Drug and Severity of Treatment-emergent Adverse Events | Unlikely related | 0 TEAE |
| Group I 100mg + Food | Relationship to Study Drug and Severity of Treatment-emergent Adverse Events | TEAE | 1 TEAE |
| Group I 100mg + Food | Relationship to Study Drug and Severity of Treatment-emergent Adverse Events | Related | 0 TEAE |
| MAD Group III 200mg | Relationship to Study Drug and Severity of Treatment-emergent Adverse Events | TEAE | 9 TEAE |
| MAD Group III 200mg | Relationship to Study Drug and Severity of Treatment-emergent Adverse Events | Serious TEAE | 0 TEAE |
| MAD Group III 200mg | Relationship to Study Drug and Severity of Treatment-emergent Adverse Events | Not related TEAE | 1 TEAE |
| MAD Group III 200mg | Relationship to Study Drug and Severity of Treatment-emergent Adverse Events | Related | 0 TEAE |
| MAD Group III 200mg | Relationship to Study Drug and Severity of Treatment-emergent Adverse Events | Unlikely related | 1 TEAE |
| MAD Group III 200mg | Relationship to Study Drug and Severity of Treatment-emergent Adverse Events | Possibly related | 7 TEAE |
| MAD Group IV 400mg | Relationship to Study Drug and Severity of Treatment-emergent Adverse Events | TEAE | 6 TEAE |
| MAD Group IV 400mg | Relationship to Study Drug and Severity of Treatment-emergent Adverse Events | Not related TEAE | 1 TEAE |
| MAD Group IV 400mg | Relationship to Study Drug and Severity of Treatment-emergent Adverse Events | Serious TEAE | 0 TEAE |
| MAD Group IV 400mg | Relationship to Study Drug and Severity of Treatment-emergent Adverse Events | Unlikely related | 1 TEAE |
| MAD Group IV 400mg | Relationship to Study Drug and Severity of Treatment-emergent Adverse Events | Possibly related | 4 TEAE |
| MAD Group IV 400mg | Relationship to Study Drug and Severity of Treatment-emergent Adverse Events | Related | 0 TEAE |
| MAD Group V 800mg | Relationship to Study Drug and Severity of Treatment-emergent Adverse Events | Unlikely related | 2 TEAE |
| MAD Group V 800mg | Relationship to Study Drug and Severity of Treatment-emergent Adverse Events | Related | 0 TEAE |
| MAD Group V 800mg | Relationship to Study Drug and Severity of Treatment-emergent Adverse Events | Not related TEAE | 3 TEAE |
| MAD Group V 800mg | Relationship to Study Drug and Severity of Treatment-emergent Adverse Events | TEAE | 14 TEAE |
| MAD Group V 800mg | Relationship to Study Drug and Severity of Treatment-emergent Adverse Events | Possibly related | 9 TEAE |
| MAD Group V 800mg | Relationship to Study Drug and Severity of Treatment-emergent Adverse Events | Serious TEAE | 0 TEAE |
| Placebo | Relationship to Study Drug and Severity of Treatment-emergent Adverse Events | Not related TEAE | 3 TEAE |
| Placebo | Relationship to Study Drug and Severity of Treatment-emergent Adverse Events | Unlikely related | 1 TEAE |
| Placebo | Relationship to Study Drug and Severity of Treatment-emergent Adverse Events | Possibly related | 13 TEAE |
| Placebo | Relationship to Study Drug and Severity of Treatment-emergent Adverse Events | Serious TEAE | 0 TEAE |
| Placebo | Relationship to Study Drug and Severity of Treatment-emergent Adverse Events | TEAE | 17 TEAE |
| Placebo | Relationship to Study Drug and Severity of Treatment-emergent Adverse Events | Related | 0 TEAE |
Primary
SAD: Change From Baseline in ECG Results by Timepoint: Corrected QT Interval According to Fridericia's Formula (QTcF)
The baseline ECG recording consists of a triplicate recording (3 recordings of a least 3 complexes within a 5 minute window) prior to dosing on Day 1. For the evaluation of the corrected QT intervals the average of the 3 recordings will be taken as baseline. Other ECG recordings will be singlet (one recording of at least 3 complexes) prior to dosing. QTcF is calculated as the quotient between the QT interval in milliseconds and the cube root of the RR interval in seconds, according to Fridericia's formula.
Time frame: Baseline, 1, 2, 4, 6, 8, 12, 24 hours, 7 day follow up
Population: The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group I Placebo | SAD: Change From Baseline in ECG Results by Timepoint: Corrected QT Interval According to Fridericia's Formula (QTcF) | Change from BL at 12h | 1.8 msec | Standard Deviation 6.7 |
| Group I Placebo | SAD: Change From Baseline in ECG Results by Timepoint: Corrected QT Interval According to Fridericia's Formula (QTcF) | Change from BL at 24h | 5.3 msec | Standard Deviation 12.4 |
| Group I Placebo | SAD: Change From Baseline in ECG Results by Timepoint: Corrected QT Interval According to Fridericia's Formula (QTcF) | Change from BL at FU | -0.3 msec | Standard Deviation 12.4 |
| Group I Placebo | SAD: Change From Baseline in ECG Results by Timepoint: Corrected QT Interval According to Fridericia's Formula (QTcF) | Change from BL at 6h | 6.2 msec | Standard Deviation 3.6 |
| Group I Placebo | SAD: Change From Baseline in ECG Results by Timepoint: Corrected QT Interval According to Fridericia's Formula (QTcF) | Change from baseline (BL)at 1h | 4.0 msec | Standard Deviation 2.8 |
| Group I Placebo | SAD: Change From Baseline in ECG Results by Timepoint: Corrected QT Interval According to Fridericia's Formula (QTcF) | Change from BL at 4h | 6.5 msec | Standard Deviation 9.4 |
| Group I Placebo | SAD: Change From Baseline in ECG Results by Timepoint: Corrected QT Interval According to Fridericia's Formula (QTcF) | Change from BL at 2h | 0.5 msec | Standard Deviation 7.9 |
| Group I Placebo | SAD: Change From Baseline in ECG Results by Timepoint: Corrected QT Interval According to Fridericia's Formula (QTcF) | Change from BL at 8h | -0.8 msec | Standard Deviation 7.3 |
| Group I Placebo | SAD: Change From Baseline in ECG Results by Timepoint: Corrected QT Interval According to Fridericia's Formula (QTcF) | Baseline (Pre-dose Day 1) | 386.2 msec | Standard Deviation 17.2 |
| Group II Placebo | SAD: Change From Baseline in ECG Results by Timepoint: Corrected QT Interval According to Fridericia's Formula (QTcF) | Change from BL at 8h | -7.2 msec | Standard Deviation 4 |
| Group II Placebo | SAD: Change From Baseline in ECG Results by Timepoint: Corrected QT Interval According to Fridericia's Formula (QTcF) | Change from BL at 2h | -4.0 msec | Standard Deviation 6.6 |
| Group II Placebo | SAD: Change From Baseline in ECG Results by Timepoint: Corrected QT Interval According to Fridericia's Formula (QTcF) | Change from BL at 12h | -5.2 msec | Standard Deviation 4.8 |
| Group II Placebo | SAD: Change From Baseline in ECG Results by Timepoint: Corrected QT Interval According to Fridericia's Formula (QTcF) | Change from BL at 24h | -7.5 msec | Standard Deviation 9.3 |
| Group II Placebo | SAD: Change From Baseline in ECG Results by Timepoint: Corrected QT Interval According to Fridericia's Formula (QTcF) | Change from baseline (BL)at 1h | -2.0 msec | Standard Deviation 8.7 |
| Group II Placebo | SAD: Change From Baseline in ECG Results by Timepoint: Corrected QT Interval According to Fridericia's Formula (QTcF) | Change from BL at FU | 2.8 msec | Standard Deviation 7.9 |
| Group II Placebo | SAD: Change From Baseline in ECG Results by Timepoint: Corrected QT Interval According to Fridericia's Formula (QTcF) | Change from BL at 6h | -2.7 msec | Standard Deviation 6 |
| Group II Placebo | SAD: Change From Baseline in ECG Results by Timepoint: Corrected QT Interval According to Fridericia's Formula (QTcF) | Baseline (Pre-dose Day 1) | 395.0 msec | Standard Deviation 9.8 |
| Group II Placebo | SAD: Change From Baseline in ECG Results by Timepoint: Corrected QT Interval According to Fridericia's Formula (QTcF) | Change from BL at 4h | -2.2 msec | Standard Deviation 11.4 |
| SAD Group I 10mg | SAD: Change From Baseline in ECG Results by Timepoint: Corrected QT Interval According to Fridericia's Formula (QTcF) | Change from BL at 8h | -5.5 msec | Standard Deviation 7.4 |
| SAD Group I 10mg | SAD: Change From Baseline in ECG Results by Timepoint: Corrected QT Interval According to Fridericia's Formula (QTcF) | Change from BL at FU | -1.3 msec | Standard Deviation 10.8 |
| SAD Group I 10mg | SAD: Change From Baseline in ECG Results by Timepoint: Corrected QT Interval According to Fridericia's Formula (QTcF) | Change from BL at 4h | -3.8 msec | Standard Deviation 3.3 |
| SAD Group I 10mg | SAD: Change From Baseline in ECG Results by Timepoint: Corrected QT Interval According to Fridericia's Formula (QTcF) | Change from BL at 12h | -1.8 msec | Standard Deviation 2.6 |
| SAD Group I 10mg | SAD: Change From Baseline in ECG Results by Timepoint: Corrected QT Interval According to Fridericia's Formula (QTcF) | Change from BL at 6h | 4.3 msec | Standard Deviation 6.3 |
| SAD Group I 10mg | SAD: Change From Baseline in ECG Results by Timepoint: Corrected QT Interval According to Fridericia's Formula (QTcF) | Change from BL at 2h | -1.8 msec | Standard Deviation 7.9 |
| SAD Group I 10mg | SAD: Change From Baseline in ECG Results by Timepoint: Corrected QT Interval According to Fridericia's Formula (QTcF) | Change from baseline (BL)at 1h | -0.3 msec | Standard Deviation 3.8 |
| SAD Group I 10mg | SAD: Change From Baseline in ECG Results by Timepoint: Corrected QT Interval According to Fridericia's Formula (QTcF) | Baseline (Pre-dose Day 1) | 385.8 msec | Standard Deviation 14.8 |
| SAD Group I 10mg | SAD: Change From Baseline in ECG Results by Timepoint: Corrected QT Interval According to Fridericia's Formula (QTcF) | Change from BL at 24h | -4.0 msec | Standard Deviation 7.3 |
| SAD Group II 30mg | SAD: Change From Baseline in ECG Results by Timepoint: Corrected QT Interval According to Fridericia's Formula (QTcF) | Change from BL at 2h | -4.8 msec | Standard Deviation 6.1 |
| SAD Group II 30mg | SAD: Change From Baseline in ECG Results by Timepoint: Corrected QT Interval According to Fridericia's Formula (QTcF) | Change from BL at 4h | -4.3 msec | Standard Deviation 6.2 |
| SAD Group II 30mg | SAD: Change From Baseline in ECG Results by Timepoint: Corrected QT Interval According to Fridericia's Formula (QTcF) | Baseline (Pre-dose Day 1) | 399.3 msec | Standard Deviation 8.3 |
| SAD Group II 30mg | SAD: Change From Baseline in ECG Results by Timepoint: Corrected QT Interval According to Fridericia's Formula (QTcF) | Change from BL at 24h | -4.8 msec | Standard Deviation 5.6 |
| SAD Group II 30mg | SAD: Change From Baseline in ECG Results by Timepoint: Corrected QT Interval According to Fridericia's Formula (QTcF) | Change from BL at 6h | -4.0 msec | Standard Deviation 7.3 |
| SAD Group II 30mg | SAD: Change From Baseline in ECG Results by Timepoint: Corrected QT Interval According to Fridericia's Formula (QTcF) | Change from BL at 8h | -1.8 msec | Standard Deviation 9.2 |
| SAD Group II 30mg | SAD: Change From Baseline in ECG Results by Timepoint: Corrected QT Interval According to Fridericia's Formula (QTcF) | Change from BL at FU | 2.8 msec | Standard Deviation 8 |
| SAD Group II 30mg | SAD: Change From Baseline in ECG Results by Timepoint: Corrected QT Interval According to Fridericia's Formula (QTcF) | Change from baseline (BL)at 1h | -3.5 msec | Standard Deviation 6 |
| SAD Group II 30mg | SAD: Change From Baseline in ECG Results by Timepoint: Corrected QT Interval According to Fridericia's Formula (QTcF) | Change from BL at 12h | -7.3 msec | Standard Deviation 6.8 |
| SAD Group I 100mg | SAD: Change From Baseline in ECG Results by Timepoint: Corrected QT Interval According to Fridericia's Formula (QTcF) | Change from BL at FU | 2.8 msec | Standard Deviation 13.1 |
| SAD Group I 100mg | SAD: Change From Baseline in ECG Results by Timepoint: Corrected QT Interval According to Fridericia's Formula (QTcF) | Change from BL at 4h | 1.0 msec | Standard Deviation 5.7 |
| SAD Group I 100mg | SAD: Change From Baseline in ECG Results by Timepoint: Corrected QT Interval According to Fridericia's Formula (QTcF) | Change from BL at 8h | 4.3 msec | Standard Deviation 10.3 |
| SAD Group I 100mg | SAD: Change From Baseline in ECG Results by Timepoint: Corrected QT Interval According to Fridericia's Formula (QTcF) | Change from BL at 12h | 0.0 msec | Standard Deviation 4.7 |
| SAD Group I 100mg | SAD: Change From Baseline in ECG Results by Timepoint: Corrected QT Interval According to Fridericia's Formula (QTcF) | Change from BL at 24h | 0.3 msec | Standard Deviation 6.2 |
| SAD Group I 100mg | SAD: Change From Baseline in ECG Results by Timepoint: Corrected QT Interval According to Fridericia's Formula (QTcF) | Baseline (Pre-dose Day 1) | 390.3 msec | Standard Deviation 14.6 |
| SAD Group I 100mg | SAD: Change From Baseline in ECG Results by Timepoint: Corrected QT Interval According to Fridericia's Formula (QTcF) | Change from baseline (BL)at 1h | 0.8 msec | Standard Deviation 4 |
| SAD Group I 100mg | SAD: Change From Baseline in ECG Results by Timepoint: Corrected QT Interval According to Fridericia's Formula (QTcF) | Change from BL at 2h | -4.8 msec | Standard Deviation 3 |
| SAD Group I 100mg | SAD: Change From Baseline in ECG Results by Timepoint: Corrected QT Interval According to Fridericia's Formula (QTcF) | Change from BL at 6h | -1.0 msec | Standard Deviation 8.3 |
| SAD Group II 300mg | SAD: Change From Baseline in ECG Results by Timepoint: Corrected QT Interval According to Fridericia's Formula (QTcF) | Change from BL at 4h | 3.8 msec | Standard Deviation 12.3 |
| SAD Group II 300mg | SAD: Change From Baseline in ECG Results by Timepoint: Corrected QT Interval According to Fridericia's Formula (QTcF) | Change from BL at 2h | 1.5 msec | Standard Deviation 6 |
| SAD Group II 300mg | SAD: Change From Baseline in ECG Results by Timepoint: Corrected QT Interval According to Fridericia's Formula (QTcF) | Baseline (Pre-dose Day 1) | 393.5 msec | Standard Deviation 14.2 |
| SAD Group II 300mg | SAD: Change From Baseline in ECG Results by Timepoint: Corrected QT Interval According to Fridericia's Formula (QTcF) | Change from BL at FU | 5.0 msec | Standard Deviation 6.1 |
| SAD Group II 300mg | SAD: Change From Baseline in ECG Results by Timepoint: Corrected QT Interval According to Fridericia's Formula (QTcF) | Change from baseline (BL)at 1h | 0.8 msec | Standard Deviation 5.7 |
| SAD Group II 300mg | SAD: Change From Baseline in ECG Results by Timepoint: Corrected QT Interval According to Fridericia's Formula (QTcF) | Change from BL at 8h | -1.8 msec | Standard Deviation 9 |
| SAD Group II 300mg | SAD: Change From Baseline in ECG Results by Timepoint: Corrected QT Interval According to Fridericia's Formula (QTcF) | Change from BL at 6h | 5.8 msec | Standard Deviation 8.1 |
| SAD Group II 300mg | SAD: Change From Baseline in ECG Results by Timepoint: Corrected QT Interval According to Fridericia's Formula (QTcF) | Change from BL at 12h | 0.0 msec | Standard Deviation 8 |
| SAD Group II 300mg | SAD: Change From Baseline in ECG Results by Timepoint: Corrected QT Interval According to Fridericia's Formula (QTcF) | Change from BL at 24h | -4.3 msec | Standard Deviation 6.5 |
| SAD Group I 800mg | SAD: Change From Baseline in ECG Results by Timepoint: Corrected QT Interval According to Fridericia's Formula (QTcF) | Change from BL at 12h | 8.0 msec | Standard Deviation 0.8 |
| SAD Group I 800mg | SAD: Change From Baseline in ECG Results by Timepoint: Corrected QT Interval According to Fridericia's Formula (QTcF) | Change from BL at 8h | 0.8 msec | Standard Deviation 7.5 |
| SAD Group I 800mg | SAD: Change From Baseline in ECG Results by Timepoint: Corrected QT Interval According to Fridericia's Formula (QTcF) | Change from baseline (BL)at 1h | 0.3 msec | Standard Deviation 7.6 |
| SAD Group I 800mg | SAD: Change From Baseline in ECG Results by Timepoint: Corrected QT Interval According to Fridericia's Formula (QTcF) | Change from BL at 6h | 5.5 msec | Standard Deviation 2.5 |
| SAD Group I 800mg | SAD: Change From Baseline in ECG Results by Timepoint: Corrected QT Interval According to Fridericia's Formula (QTcF) | Change from BL at FU | -5.0 msec | Standard Deviation 3.2 |
| SAD Group I 800mg | SAD: Change From Baseline in ECG Results by Timepoint: Corrected QT Interval According to Fridericia's Formula (QTcF) | Change from BL at 2h | 7.8 msec | Standard Deviation 10 |
| SAD Group I 800mg | SAD: Change From Baseline in ECG Results by Timepoint: Corrected QT Interval According to Fridericia's Formula (QTcF) | Baseline (Pre-dose Day 1) | 386.5 msec | Standard Deviation 10.9 |
| SAD Group I 800mg | SAD: Change From Baseline in ECG Results by Timepoint: Corrected QT Interval According to Fridericia's Formula (QTcF) | Change from BL at 24h | 0.3 msec | Standard Deviation 9.7 |
| SAD Group I 800mg | SAD: Change From Baseline in ECG Results by Timepoint: Corrected QT Interval According to Fridericia's Formula (QTcF) | Change from BL at 4h | 3.3 msec | Standard Deviation 7.2 |
| SAD Group II 2000mg | SAD: Change From Baseline in ECG Results by Timepoint: Corrected QT Interval According to Fridericia's Formula (QTcF) | Baseline (Pre-dose Day 1) | 385.3 msec | Standard Deviation 16.8 |
| SAD Group II 2000mg | SAD: Change From Baseline in ECG Results by Timepoint: Corrected QT Interval According to Fridericia's Formula (QTcF) | Change from BL at 24h | 11.3 msec | Standard Deviation 4.7 |
| SAD Group II 2000mg | SAD: Change From Baseline in ECG Results by Timepoint: Corrected QT Interval According to Fridericia's Formula (QTcF) | Change from BL at 6h | 26.0 msec | Standard Deviation 7.9 |
| SAD Group II 2000mg | SAD: Change From Baseline in ECG Results by Timepoint: Corrected QT Interval According to Fridericia's Formula (QTcF) | Change from BL at 12h | 19.3 msec | Standard Deviation 11.1 |
| SAD Group II 2000mg | SAD: Change From Baseline in ECG Results by Timepoint: Corrected QT Interval According to Fridericia's Formula (QTcF) | Change from BL at 2h | 28.5 msec | Standard Deviation 14.1 |
| SAD Group II 2000mg | SAD: Change From Baseline in ECG Results by Timepoint: Corrected QT Interval According to Fridericia's Formula (QTcF) | Change from BL at 4h | 26.0 msec | Standard Deviation 8.7 |
| SAD Group II 2000mg | SAD: Change From Baseline in ECG Results by Timepoint: Corrected QT Interval According to Fridericia's Formula (QTcF) | Change from BL at FU | 3.3 msec | Standard Deviation 7.6 |
| SAD Group II 2000mg | SAD: Change From Baseline in ECG Results by Timepoint: Corrected QT Interval According to Fridericia's Formula (QTcF) | Change from BL at 8h | 23.3 msec | Standard Deviation 12.3 |
| SAD Group II 2000mg | SAD: Change From Baseline in ECG Results by Timepoint: Corrected QT Interval According to Fridericia's Formula (QTcF) | Change from baseline (BL)at 1h | 28.8 msec | Standard Deviation 19 |
| Group I Placebo + Food | SAD: Change From Baseline in ECG Results by Timepoint: Corrected QT Interval According to Fridericia's Formula (QTcF) | Change from BL at 8h | -2.5 msec | Standard Deviation 13.4 |
| Group I Placebo + Food | SAD: Change From Baseline in ECG Results by Timepoint: Corrected QT Interval According to Fridericia's Formula (QTcF) | Change from BL at FU | 5.5 msec | Standard Deviation 10.6 |
| Group I Placebo + Food | SAD: Change From Baseline in ECG Results by Timepoint: Corrected QT Interval According to Fridericia's Formula (QTcF) | Change from BL at 12h | 5.5 msec | Standard Deviation 7.8 |
| Group I Placebo + Food | SAD: Change From Baseline in ECG Results by Timepoint: Corrected QT Interval According to Fridericia's Formula (QTcF) | Baseline (Pre-dose Day 1) | 369.0 msec | Standard Deviation 14.1 |
| Group I Placebo + Food | SAD: Change From Baseline in ECG Results by Timepoint: Corrected QT Interval According to Fridericia's Formula (QTcF) | Change from baseline (BL)at 1h | 4.5 msec | Standard Deviation 19.1 |
| Group I Placebo + Food | SAD: Change From Baseline in ECG Results by Timepoint: Corrected QT Interval According to Fridericia's Formula (QTcF) | Change from BL at 6h | 8.5 msec | Standard Deviation 12 |
| Group I Placebo + Food | SAD: Change From Baseline in ECG Results by Timepoint: Corrected QT Interval According to Fridericia's Formula (QTcF) | Change from BL at 2h | 2.5 msec | Standard Deviation 13.4 |
| Group I Placebo + Food | SAD: Change From Baseline in ECG Results by Timepoint: Corrected QT Interval According to Fridericia's Formula (QTcF) | Change from BL at 4h | 8.5 msec | Standard Deviation 17.7 |
| Group I Placebo + Food | SAD: Change From Baseline in ECG Results by Timepoint: Corrected QT Interval According to Fridericia's Formula (QTcF) | Change from BL at 24h | -1.0 msec | Standard Deviation 8.5 |
| Group I 100mg + Food | SAD: Change From Baseline in ECG Results by Timepoint: Corrected QT Interval According to Fridericia's Formula (QTcF) | Change from BL at 12h | 3.3 msec | Standard Deviation 6.2 |
| Group I 100mg + Food | SAD: Change From Baseline in ECG Results by Timepoint: Corrected QT Interval According to Fridericia's Formula (QTcF) | Change from baseline (BL)at 1h | 5.8 msec | Standard Deviation 2.6 |
| Group I 100mg + Food | SAD: Change From Baseline in ECG Results by Timepoint: Corrected QT Interval According to Fridericia's Formula (QTcF) | Baseline (Pre-dose Day 1) | 386.5 msec | Standard Deviation 13.2 |
| Group I 100mg + Food | SAD: Change From Baseline in ECG Results by Timepoint: Corrected QT Interval According to Fridericia's Formula (QTcF) | Change from BL at 8h | 0.5 msec | Standard Deviation 5.4 |
| Group I 100mg + Food | SAD: Change From Baseline in ECG Results by Timepoint: Corrected QT Interval According to Fridericia's Formula (QTcF) | Change from BL at 4h | 0.3 msec | Standard Deviation 3.9 |
| Group I 100mg + Food | SAD: Change From Baseline in ECG Results by Timepoint: Corrected QT Interval According to Fridericia's Formula (QTcF) | Change from BL at 24h | -3.8 msec | Standard Deviation 4 |
| Group I 100mg + Food | SAD: Change From Baseline in ECG Results by Timepoint: Corrected QT Interval According to Fridericia's Formula (QTcF) | Change from BL at FU | 6.5 msec | Standard Deviation 13 |
| Group I 100mg + Food | SAD: Change From Baseline in ECG Results by Timepoint: Corrected QT Interval According to Fridericia's Formula (QTcF) | Change from BL at 2h | 1.8 msec | Standard Deviation 5.3 |
| Group I 100mg + Food | SAD: Change From Baseline in ECG Results by Timepoint: Corrected QT Interval According to Fridericia's Formula (QTcF) | Change from BL at 6h | 6.0 msec | Standard Deviation 5 |
Primary
SAD: Change From Baseline in ECG Results by Time Point: PQ Interval
The baseline ECG recording consists of a triplicate recording (3 recordings of a least 3 complexes within a 5 minute window) prior to dosing on Day 1. For the evaluation the average of the 3 recordings will be taken as baseline.
Time frame: Pre-dose, Day 1, Day 7
Population: Per protocol set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group I Placebo | SAD: Change From Baseline in ECG Results by Time Point: PQ Interval | Change from baseline at 1h | -1.2 msec | Standard Deviation 4 |
| Group I Placebo | SAD: Change From Baseline in ECG Results by Time Point: PQ Interval | Change from BL at 8h post dose | -3.2 msec | Standard Deviation 3.6 |
| Group I Placebo | SAD: Change From Baseline in ECG Results by Time Point: PQ Interval | Change from BL at 2h post dose | 1.2 msec | Standard Deviation 3.9 |
| Group I Placebo | SAD: Change From Baseline in ECG Results by Time Point: PQ Interval | Change from BL at 24h post dose | -2.2 msec | Standard Deviation 3.3 |
| Group I Placebo | SAD: Change From Baseline in ECG Results by Time Point: PQ Interval | Change from BL at FU | -5.5 msec | Standard Deviation 4.9 |
| Group I Placebo | SAD: Change From Baseline in ECG Results by Time Point: PQ Interval | Change from BL at 6h post dose | -1.2 msec | Standard Deviation 3.6 |
| Group I Placebo | SAD: Change From Baseline in ECG Results by Time Point: PQ Interval | Change from BL at 4h post dose | -1.5 msec | Standard Deviation 8.8 |
| Group I Placebo | SAD: Change From Baseline in ECG Results by Time Point: PQ Interval | Baseline (Pre-dose Day 1) | 195.5 msec | Standard Deviation 28.9 |
| Group I Placebo | SAD: Change From Baseline in ECG Results by Time Point: PQ Interval | Change from BLat 12h post dose | -1.8 msec | Standard Deviation 4.7 |
| Group II Placebo | SAD: Change From Baseline in ECG Results by Time Point: PQ Interval | Change from BL at 24h post dose | -3.7 msec | Standard Deviation 8.5 |
| Group II Placebo | SAD: Change From Baseline in ECG Results by Time Point: PQ Interval | Change from BL at FU | -1.3 msec | Standard Deviation 7.4 |
| Group II Placebo | SAD: Change From Baseline in ECG Results by Time Point: PQ Interval | Change from BL at 6h post dose | -2.7 msec | Standard Deviation 3.3 |
| Group II Placebo | SAD: Change From Baseline in ECG Results by Time Point: PQ Interval | Change from BL at 2h post dose | -0.7 msec | Standard Deviation 3.7 |
| Group II Placebo | SAD: Change From Baseline in ECG Results by Time Point: PQ Interval | Change from BL at 8h post dose | 1.0 msec | Standard Deviation 6.2 |
| Group II Placebo | SAD: Change From Baseline in ECG Results by Time Point: PQ Interval | Change from baseline at 1h | 3.3 msec | Standard Deviation 7.4 |
| Group II Placebo | SAD: Change From Baseline in ECG Results by Time Point: PQ Interval | Change from BLat 12h post dose | -3.7 msec | Standard Deviation 8.3 |
| Group II Placebo | SAD: Change From Baseline in ECG Results by Time Point: PQ Interval | Change from BL at 4h post dose | -2.3 msec | Standard Deviation 0.8 |
| Group II Placebo | SAD: Change From Baseline in ECG Results by Time Point: PQ Interval | Baseline (Pre-dose Day 1) | 165.0 msec | Standard Deviation 21.6 |
| SAD Group I 10mg | SAD: Change From Baseline in ECG Results by Time Point: PQ Interval | Change from BL at 8h post dose | -6.5 msec | Standard Deviation 5.5 |
| SAD Group I 10mg | SAD: Change From Baseline in ECG Results by Time Point: PQ Interval | Change from BL at 4h post dose | -2.0 msec | Standard Deviation 2.6 |
| SAD Group I 10mg | SAD: Change From Baseline in ECG Results by Time Point: PQ Interval | Change from baseline at 1h | -0.5 msec | Standard Deviation 1.9 |
| SAD Group I 10mg | SAD: Change From Baseline in ECG Results by Time Point: PQ Interval | Change from BL at 6h post dose | -2.0 msec | Standard Deviation 2.6 |
| SAD Group I 10mg | SAD: Change From Baseline in ECG Results by Time Point: PQ Interval | Change from BLat 12h post dose | -4.0 msec | Standard Deviation 4.8 |
| SAD Group I 10mg | SAD: Change From Baseline in ECG Results by Time Point: PQ Interval | Change from BL at FU | -5.0 msec | Standard Deviation 4.3 |
| SAD Group I 10mg | SAD: Change From Baseline in ECG Results by Time Point: PQ Interval | Change from BL at 2h post dose | -3.0 msec | Standard Deviation 3.7 |
| SAD Group I 10mg | SAD: Change From Baseline in ECG Results by Time Point: PQ Interval | Baseline (Pre-dose Day 1) | 154.5 msec | Standard Deviation 39.2 |
| SAD Group I 10mg | SAD: Change From Baseline in ECG Results by Time Point: PQ Interval | Change from BL at 24h post dose | -4.5 msec | Standard Deviation 8.4 |
| SAD Group II 30mg | SAD: Change From Baseline in ECG Results by Time Point: PQ Interval | Change from BL at 24h post dose | -4.3 msec | Standard Deviation 2.6 |
| SAD Group II 30mg | SAD: Change From Baseline in ECG Results by Time Point: PQ Interval | Change from BLat 12h post dose | -1.8 msec | Standard Deviation 4.9 |
| SAD Group II 30mg | SAD: Change From Baseline in ECG Results by Time Point: PQ Interval | Change from baseline at 1h | -1.3 msec | Standard Deviation 5.7 |
| SAD Group II 30mg | SAD: Change From Baseline in ECG Results by Time Point: PQ Interval | Change from BL at 2h post dose | 1.3 msec | Standard Deviation 3.8 |
| SAD Group II 30mg | SAD: Change From Baseline in ECG Results by Time Point: PQ Interval | Change from BL at 8h post dose | -1.3 msec | Standard Deviation 7.4 |
| SAD Group II 30mg | SAD: Change From Baseline in ECG Results by Time Point: PQ Interval | Change from BL at 4h post dose | 4.8 msec | Standard Deviation 4.4 |
| SAD Group II 30mg | SAD: Change From Baseline in ECG Results by Time Point: PQ Interval | Baseline (Pre-dose Day 1) | 159.8 msec | Standard Deviation 23 |
| SAD Group II 30mg | SAD: Change From Baseline in ECG Results by Time Point: PQ Interval | Change from BL at 6h post dose | 0.8 msec | Standard Deviation 7.2 |
| SAD Group II 30mg | SAD: Change From Baseline in ECG Results by Time Point: PQ Interval | Change from BL at FU | -7.3 msec | Standard Deviation 2.2 |
| SAD Group I 100mg | SAD: Change From Baseline in ECG Results by Time Point: PQ Interval | Change from BL at 2h post dose | -3.0 msec | Standard Deviation 3.8 |
| SAD Group I 100mg | SAD: Change From Baseline in ECG Results by Time Point: PQ Interval | Change from BL at 6h post dose | -7.5 msec | Standard Deviation 5.3 |
| SAD Group I 100mg | SAD: Change From Baseline in ECG Results by Time Point: PQ Interval | Change from BL at 8h post dose | -8.0 msec | Standard Deviation 4.3 |
| SAD Group I 100mg | SAD: Change From Baseline in ECG Results by Time Point: PQ Interval | Change from BLat 12h post dose | -6.5 msec | Standard Deviation 4.4 |
| SAD Group I 100mg | SAD: Change From Baseline in ECG Results by Time Point: PQ Interval | Change from BL at 24h post dose | -7.0 msec | Standard Deviation 3.5 |
| SAD Group I 100mg | SAD: Change From Baseline in ECG Results by Time Point: PQ Interval | Change from BL at FU | -11.0 msec | Standard Deviation 5.3 |
| SAD Group I 100mg | SAD: Change From Baseline in ECG Results by Time Point: PQ Interval | Baseline (Pre-dose Day 1) | 155.0 msec | Standard Deviation 24.4 |
| SAD Group I 100mg | SAD: Change From Baseline in ECG Results by Time Point: PQ Interval | Change from baseline at 1h | -4.0 msec | Standard Deviation 3.7 |
| SAD Group I 100mg | SAD: Change From Baseline in ECG Results by Time Point: PQ Interval | Change from BL at 4h post dose | -3.5 msec | Standard Deviation 5.3 |
| SAD Group II 300mg | SAD: Change From Baseline in ECG Results by Time Point: PQ Interval | Change from BLat 12h post dose | -9.5 msec | Standard Deviation 10.6 |
| SAD Group II 300mg | SAD: Change From Baseline in ECG Results by Time Point: PQ Interval | Change from BL at 24h post dose | -6.5 msec | Standard Deviation 3 |
| SAD Group II 300mg | SAD: Change From Baseline in ECG Results by Time Point: PQ Interval | Change from BL at 6h post dose | -5.5 msec | Standard Deviation 8.5 |
| SAD Group II 300mg | SAD: Change From Baseline in ECG Results by Time Point: PQ Interval | Change from baseline at 1h | 4.0 msec | Standard Deviation 2.8 |
| SAD Group II 300mg | SAD: Change From Baseline in ECG Results by Time Point: PQ Interval | Change from BL at FU | -3.0 msec | Standard Deviation 9.3 |
| SAD Group II 300mg | SAD: Change From Baseline in ECG Results by Time Point: PQ Interval | Change from BL at 2h post dose | 4.5 msec | Standard Deviation 5.7 |
| SAD Group II 300mg | SAD: Change From Baseline in ECG Results by Time Point: PQ Interval | Change from BL at 4h post dose | 0.0 msec | Standard Deviation 4 |
| SAD Group II 300mg | SAD: Change From Baseline in ECG Results by Time Point: PQ Interval | Change from BL at 8h post dose | -8.0 msec | Standard Deviation 8.6 |
| SAD Group II 300mg | SAD: Change From Baseline in ECG Results by Time Point: PQ Interval | Baseline (Pre-dose Day 1) | 176.5 msec | Standard Deviation 21.4 |
| SAD Group I 800mg | SAD: Change From Baseline in ECG Results by Time Point: PQ Interval | Change from BLat 12h post dose | -4.3 msec | Standard Deviation 5.7 |
| SAD Group I 800mg | SAD: Change From Baseline in ECG Results by Time Point: PQ Interval | Change from BL at FU | -9.8 msec | Standard Deviation 4.9 |
| SAD Group I 800mg | SAD: Change From Baseline in ECG Results by Time Point: PQ Interval | Change from BL at 4h post dose | 3.3 msec | Standard Deviation 5.7 |
| SAD Group I 800mg | SAD: Change From Baseline in ECG Results by Time Point: PQ Interval | Baseline (Pre-dose Day 1) | 171.8 msec | Standard Deviation 15.9 |
| SAD Group I 800mg | SAD: Change From Baseline in ECG Results by Time Point: PQ Interval | Change from BL at 8h post dose | -5.3 msec | Standard Deviation 7.8 |
| SAD Group I 800mg | SAD: Change From Baseline in ECG Results by Time Point: PQ Interval | Change from baseline at 1h | 8.8 msec | Standard Deviation 3 |
| SAD Group I 800mg | SAD: Change From Baseline in ECG Results by Time Point: PQ Interval | Change from BL at 6h post dose | -3.3 msec | Standard Deviation 8.8 |
| SAD Group I 800mg | SAD: Change From Baseline in ECG Results by Time Point: PQ Interval | Change from BL at 2h post dose | 8.3 msec | Standard Deviation 11.8 |
| SAD Group I 800mg | SAD: Change From Baseline in ECG Results by Time Point: PQ Interval | Change from BL at 24h post dose | -4.3 msec | Standard Deviation 4.9 |
| SAD Group II 2000mg | SAD: Change From Baseline in ECG Results by Time Point: PQ Interval | Change from baseline at 1h | 20.5 msec | Standard Deviation 7.5 |
| SAD Group II 2000mg | SAD: Change From Baseline in ECG Results by Time Point: PQ Interval | Change from BLat 12h post dose | 0.5 msec | Standard Deviation 7.7 |
| SAD Group II 2000mg | SAD: Change From Baseline in ECG Results by Time Point: PQ Interval | Change from BL at 2h post dose | 16.0 msec | Standard Deviation 5.9 |
| SAD Group II 2000mg | SAD: Change From Baseline in ECG Results by Time Point: PQ Interval | Baseline (Pre-dose Day 1) | 176.0 msec | Standard Deviation 17.7 |
| SAD Group II 2000mg | SAD: Change From Baseline in ECG Results by Time Point: PQ Interval | Change from BL at 6h post dose | 9.0 msec | Standard Deviation 6 |
| SAD Group II 2000mg | SAD: Change From Baseline in ECG Results by Time Point: PQ Interval | Change from BL at 8h post dose | 1.0 msec | Standard Deviation 10.4 |
| SAD Group II 2000mg | SAD: Change From Baseline in ECG Results by Time Point: PQ Interval | Change from BL at FU | -7.0 msec | Standard Deviation 2.6 |
| SAD Group II 2000mg | SAD: Change From Baseline in ECG Results by Time Point: PQ Interval | Change from BL at 4h post dose | 10.0 msec | Standard Deviation 6.3 |
| SAD Group II 2000mg | SAD: Change From Baseline in ECG Results by Time Point: PQ Interval | Change from BL at 24h post dose | -5.5 msec | Standard Deviation 8.9 |
| Group I Placebo + Food | SAD: Change From Baseline in ECG Results by Time Point: PQ Interval | Change from baseline at 1h | -9.0 msec | Standard Deviation 9.9 |
| Group I Placebo + Food | SAD: Change From Baseline in ECG Results by Time Point: PQ Interval | Change from BL at 8h post dose | -6.0 msec | Standard Deviation 2.8 |
| Group I Placebo + Food | SAD: Change From Baseline in ECG Results by Time Point: PQ Interval | Change from BL at 4h post dose | -5.0 msec | Standard Deviation 7.1 |
| Group I Placebo + Food | SAD: Change From Baseline in ECG Results by Time Point: PQ Interval | Change from BL at FU | -16.0 msec | Standard Deviation 14.1 |
| Group I Placebo + Food | SAD: Change From Baseline in ECG Results by Time Point: PQ Interval | Change from BL at 6h post dose | -11.0 msec | Standard Deviation 12.7 |
| Group I Placebo + Food | SAD: Change From Baseline in ECG Results by Time Point: PQ Interval | Change from BL at 24h post dose | 0.0 msec | Standard Deviation 0 |
| Group I Placebo + Food | SAD: Change From Baseline in ECG Results by Time Point: PQ Interval | Change from BLat 12h post dose | -9.0 msec | Standard Deviation 12.7 |
| Group I Placebo + Food | SAD: Change From Baseline in ECG Results by Time Point: PQ Interval | Change from BL at 2h post dose | -11.0 msec | Standard Deviation 9.9 |
| Group I Placebo + Food | SAD: Change From Baseline in ECG Results by Time Point: PQ Interval | Baseline (Pre-dose Day 1) | 177.0 msec | Standard Deviation 26.9 |
| Group I 100mg + Food | SAD: Change From Baseline in ECG Results by Time Point: PQ Interval | Change from BL at 6h post dose | -1.5 msec | Standard Deviation 1.9 |
| Group I 100mg + Food | SAD: Change From Baseline in ECG Results by Time Point: PQ Interval | Baseline (Pre-dose Day 1) | 147.5 msec | Standard Deviation 25.2 |
| Group I 100mg + Food | SAD: Change From Baseline in ECG Results by Time Point: PQ Interval | Change from baseline at 1h | -3.5 msec | Standard Deviation 4.4 |
| Group I 100mg + Food | SAD: Change From Baseline in ECG Results by Time Point: PQ Interval | Change from BL at 8h post dose | -4.0 msec | Standard Deviation 3.7 |
| Group I 100mg + Food | SAD: Change From Baseline in ECG Results by Time Point: PQ Interval | Change from BL at 2h post dose | -1.0 msec | Standard Deviation 2.6 |
| Group I 100mg + Food | SAD: Change From Baseline in ECG Results by Time Point: PQ Interval | Change from BL at FU | -3.5 msec | Standard Deviation 5 |
| Group I 100mg + Food | SAD: Change From Baseline in ECG Results by Time Point: PQ Interval | Change from BL at 4h post dose | -1.5 msec | Standard Deviation 3 |
| Group I 100mg + Food | SAD: Change From Baseline in ECG Results by Time Point: PQ Interval | Change from BLat 12h post dose | -1.5 msec | Standard Deviation 4.7 |
| Group I 100mg + Food | SAD: Change From Baseline in ECG Results by Time Point: PQ Interval | Change from BL at 24h post dose | -2.0 msec | Standard Deviation 2.8 |
Primary
SAD: Change From Baseline in ECG Results by Time Point: QRS Interval
The baseline ECG recording consists of a triplicate recording (3 recordings of a least 3 complexes within a 5 minute window) prior to dosing on Day 1. For the evaluation the average of the 3 recordings will be taken as baseline.
Time frame: Pre-dose, Day 1, Day 7
Population: Per protocol set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group I Placebo | SAD: Change From Baseline in ECG Results by Time Point: QRS Interval | Change from BL at 24h post dose | -2.7 msec | Standard Deviation 5.3 |
| Group I Placebo | SAD: Change From Baseline in ECG Results by Time Point: QRS Interval | Change from BL at 2h post dose | -2.0 msec | Standard Deviation 3 |
| Group I Placebo | SAD: Change From Baseline in ECG Results by Time Point: QRS Interval | Baseline (Pre-dose Day 1) | 103.0 msec | Standard Deviation 8.3 |
| Group I Placebo | SAD: Change From Baseline in ECG Results by Time Point: QRS Interval | Change from BL at 6h post dose | 0.3 msec | Standard Deviation 3.8 |
| Group I Placebo | SAD: Change From Baseline in ECG Results by Time Point: QRS Interval | Change from BL at 12h post dose | -0.7 msec | Standard Deviation 3.6 |
| Group I Placebo | SAD: Change From Baseline in ECG Results by Time Point: QRS Interval | Change from baseline at 1h | -0.7 msec | Standard Deviation 2 |
| Group I Placebo | SAD: Change From Baseline in ECG Results by Time Point: QRS Interval | Change from BL at 8h post dose | -2.0 msec | Standard Deviation 2.8 |
| Group I Placebo | SAD: Change From Baseline in ECG Results by Time Point: QRS Interval | Change from BL at FU | -1.3 msec | Standard Deviation 6.2 |
| Group I Placebo | SAD: Change From Baseline in ECG Results by Time Point: QRS Interval | Change from BL at 4h post dose | -1.0 msec | Standard Deviation 3 |
| Group II Placebo | SAD: Change From Baseline in ECG Results by Time Point: QRS Interval | Change from BL at FU | -0.7 msec | Standard Deviation 4.4 |
| Group II Placebo | SAD: Change From Baseline in ECG Results by Time Point: QRS Interval | Baseline (Pre-dose Day 1) | 97.0 msec | Standard Deviation 9.6 |
| Group II Placebo | SAD: Change From Baseline in ECG Results by Time Point: QRS Interval | Change from BL at 4h post dose | -0.7 msec | Standard Deviation 2.2 |
| Group II Placebo | SAD: Change From Baseline in ECG Results by Time Point: QRS Interval | Change from BL at 2h post dose | 0.7 msec | Standard Deviation 3.2 |
| Group II Placebo | SAD: Change From Baseline in ECG Results by Time Point: QRS Interval | Change from baseline at 1h | 1.0 msec | Standard Deviation 5.2 |
| Group II Placebo | SAD: Change From Baseline in ECG Results by Time Point: QRS Interval | Change from BL at 24h post dose | -1.7 msec | Standard Deviation 3.4 |
| Group II Placebo | SAD: Change From Baseline in ECG Results by Time Point: QRS Interval | Change from BL at 8h post dose | -1.0 msec | Standard Deviation 1.3 |
| Group II Placebo | SAD: Change From Baseline in ECG Results by Time Point: QRS Interval | Change from BL at 12h post dose | -1.7 msec | Standard Deviation 1 |
| Group II Placebo | SAD: Change From Baseline in ECG Results by Time Point: QRS Interval | Change from BL at 6h post dose | 0.3 msec | Standard Deviation 1.6 |
| SAD Group I 10mg | SAD: Change From Baseline in ECG Results by Time Point: QRS Interval | Change from BL at 2h post dose | -1.3 msec | Standard Deviation 1.3 |
| SAD Group I 10mg | SAD: Change From Baseline in ECG Results by Time Point: QRS Interval | Change from BL at 8h post dose | 1.3 msec | Standard Deviation 3.3 |
| SAD Group I 10mg | SAD: Change From Baseline in ECG Results by Time Point: QRS Interval | Change from BL at FU | -1.3 msec | Standard Deviation 3.5 |
| SAD Group I 10mg | SAD: Change From Baseline in ECG Results by Time Point: QRS Interval | Change from baseline at 1h | -1.3 msec | Standard Deviation 0.5 |
| SAD Group I 10mg | SAD: Change From Baseline in ECG Results by Time Point: QRS Interval | Baseline (Pre-dose Day 1) | 99.3 msec | Standard Deviation 3.3 |
| SAD Group I 10mg | SAD: Change From Baseline in ECG Results by Time Point: QRS Interval | Change from BL at 24h post dose | -1.3 msec | Standard Deviation 0.5 |
| SAD Group I 10mg | SAD: Change From Baseline in ECG Results by Time Point: QRS Interval | Change from BL at 4h post dose | -1.3 msec | Standard Deviation 1.7 |
| SAD Group I 10mg | SAD: Change From Baseline in ECG Results by Time Point: QRS Interval | Change from BL at 12h post dose | 0.3 msec | Standard Deviation 2.5 |
| SAD Group I 10mg | SAD: Change From Baseline in ECG Results by Time Point: QRS Interval | Change from BL at 6h post dose | 0.8 msec | Standard Deviation 2.6 |
| SAD Group II 30mg | SAD: Change From Baseline in ECG Results by Time Point: QRS Interval | Change from BL at 2h post dose | -0.3 msec | Standard Deviation 1 |
| SAD Group II 30mg | SAD: Change From Baseline in ECG Results by Time Point: QRS Interval | Change from BL at 12h post dose | -0.3 msec | Standard Deviation 2.5 |
| SAD Group II 30mg | SAD: Change From Baseline in ECG Results by Time Point: QRS Interval | Change from BL at 4h post dose | -0.8 msec | Standard Deviation 0.5 |
| SAD Group II 30mg | SAD: Change From Baseline in ECG Results by Time Point: QRS Interval | Change from BL at 6h post dose | -0.3 msec | Standard Deviation 2.8 |
| SAD Group II 30mg | SAD: Change From Baseline in ECG Results by Time Point: QRS Interval | Change from baseline at 1h | 0.3 msec | Standard Deviation 2.2 |
| SAD Group II 30mg | SAD: Change From Baseline in ECG Results by Time Point: QRS Interval | Change from BL at FU | 0.8 msec | Standard Deviation 6.4 |
| SAD Group II 30mg | SAD: Change From Baseline in ECG Results by Time Point: QRS Interval | Change from BL at 8h post dose | -0.8 msec | Standard Deviation 2.1 |
| SAD Group II 30mg | SAD: Change From Baseline in ECG Results by Time Point: QRS Interval | Baseline (Pre-dose Day 1) | 97.8 msec | Standard Deviation 7.6 |
| SAD Group II 30mg | SAD: Change From Baseline in ECG Results by Time Point: QRS Interval | Change from BL at 24h post dose | -2.3 msec | Standard Deviation 2.2 |
| SAD Group I 100mg | SAD: Change From Baseline in ECG Results by Time Point: QRS Interval | Change from BL at 8h post dose | -2.0 msec | Standard Deviation 1.6 |
| SAD Group I 100mg | SAD: Change From Baseline in ECG Results by Time Point: QRS Interval | Change from BL at 12h post dose | -1.5 msec | Standard Deviation 2.5 |
| SAD Group I 100mg | SAD: Change From Baseline in ECG Results by Time Point: QRS Interval | Change from BL at FU | -2.5 msec | Standard Deviation 4.1 |
| SAD Group I 100mg | SAD: Change From Baseline in ECG Results by Time Point: QRS Interval | Change from BL at 24h post dose | -1.5 msec | Standard Deviation 1.9 |
| SAD Group I 100mg | SAD: Change From Baseline in ECG Results by Time Point: QRS Interval | Change from baseline at 1h | 0.0 msec | Standard Deviation 2.8 |
| SAD Group I 100mg | SAD: Change From Baseline in ECG Results by Time Point: QRS Interval | Change from BL at 6h post dose | -1.5 msec | Standard Deviation 1 |
| SAD Group I 100mg | SAD: Change From Baseline in ECG Results by Time Point: QRS Interval | Change from BL at 2h post dose | -2.5 msec | Standard Deviation 1 |
| SAD Group I 100mg | SAD: Change From Baseline in ECG Results by Time Point: QRS Interval | Change from BL at 4h post dose | -2.0 msec | Standard Deviation 0 |
| SAD Group I 100mg | SAD: Change From Baseline in ECG Results by Time Point: QRS Interval | Baseline (Pre-dose Day 1) | 106.5 msec | Standard Deviation 10.2 |
| SAD Group II 300mg | SAD: Change From Baseline in ECG Results by Time Point: QRS Interval | Change from BL at 6h post dose | 3.5 msec | Standard Deviation 2.5 |
| SAD Group II 300mg | SAD: Change From Baseline in ECG Results by Time Point: QRS Interval | Baseline (Pre-dose Day 1) | 92.5 msec | Standard Deviation 13.9 |
| SAD Group II 300mg | SAD: Change From Baseline in ECG Results by Time Point: QRS Interval | Change from baseline at 1h | 3.5 msec | Standard Deviation 3.4 |
| SAD Group II 300mg | SAD: Change From Baseline in ECG Results by Time Point: QRS Interval | Change from BL at 2h post dose | 3.0 msec | Standard Deviation 2.6 |
| SAD Group II 300mg | SAD: Change From Baseline in ECG Results by Time Point: QRS Interval | Change from BL at 4h post dose | 2.0 msec | Standard Deviation 2.8 |
| SAD Group II 300mg | SAD: Change From Baseline in ECG Results by Time Point: QRS Interval | Change from BL at 8h post dose | 2.5 msec | Standard Deviation 1.9 |
| SAD Group II 300mg | SAD: Change From Baseline in ECG Results by Time Point: QRS Interval | Change from BL at 12h post dose | 1.0 msec | Standard Deviation 2.6 |
| SAD Group II 300mg | SAD: Change From Baseline in ECG Results by Time Point: QRS Interval | Change from BL at 24h post dose | 1.5 msec | Standard Deviation 4.4 |
| SAD Group II 300mg | SAD: Change From Baseline in ECG Results by Time Point: QRS Interval | Change from BL at FU | 0.0 msec | Standard Deviation 3.3 |
| SAD Group I 800mg | SAD: Change From Baseline in ECG Results by Time Point: QRS Interval | Change from BL at 8h post dose | 0.0 msec | Standard Deviation 6.7 |
| SAD Group I 800mg | SAD: Change From Baseline in ECG Results by Time Point: QRS Interval | Change from BL at 24h post dose | 0.0 msec | Standard Deviation 1.6 |
| SAD Group I 800mg | SAD: Change From Baseline in ECG Results by Time Point: QRS Interval | Change from baseline at 1h | 1.5 msec | Standard Deviation 6.4 |
| SAD Group I 800mg | SAD: Change From Baseline in ECG Results by Time Point: QRS Interval | Change from BL at 12h post dose | 2.5 msec | Standard Deviation 3 |
| SAD Group I 800mg | SAD: Change From Baseline in ECG Results by Time Point: QRS Interval | Change from BL at 2h post dose | 2.5 msec | Standard Deviation 7.2 |
| SAD Group I 800mg | SAD: Change From Baseline in ECG Results by Time Point: QRS Interval | Change from BL at 4h post dose | 2.5 msec | Standard Deviation 3 |
| SAD Group I 800mg | SAD: Change From Baseline in ECG Results by Time Point: QRS Interval | Change from BL at FU | -3.0 msec | Standard Deviation 5.3 |
| SAD Group I 800mg | SAD: Change From Baseline in ECG Results by Time Point: QRS Interval | Baseline (Pre-dose Day 1) | 104.5 msec | Standard Deviation 10.6 |
| SAD Group I 800mg | SAD: Change From Baseline in ECG Results by Time Point: QRS Interval | Change from BL at 6h post dose | 1.5 msec | Standard Deviation 2.5 |
| SAD Group II 2000mg | SAD: Change From Baseline in ECG Results by Time Point: QRS Interval | Change from BL at 12h post dose | 7.0 msec | Standard Deviation 2 |
| SAD Group II 2000mg | SAD: Change From Baseline in ECG Results by Time Point: QRS Interval | Baseline (Pre-dose Day 1) | 94.0 msec | Standard Deviation 8.8 |
| SAD Group II 2000mg | SAD: Change From Baseline in ECG Results by Time Point: QRS Interval | Change from BL at 4h post dose | 17.0 msec | Standard Deviation 6 |
| SAD Group II 2000mg | SAD: Change From Baseline in ECG Results by Time Point: QRS Interval | Change from BL at 6h post dose | 14.5 msec | Standard Deviation 5.3 |
| SAD Group II 2000mg | SAD: Change From Baseline in ECG Results by Time Point: QRS Interval | Change from BL at FU | -0.5 msec | Standard Deviation 2.5 |
| SAD Group II 2000mg | SAD: Change From Baseline in ECG Results by Time Point: QRS Interval | Change from BL at 8h post dose | 13.0 msec | Standard Deviation 4.8 |
| SAD Group II 2000mg | SAD: Change From Baseline in ECG Results by Time Point: QRS Interval | Change from BL at 2h post dose | 20.5 msec | Standard Deviation 7.7 |
| SAD Group II 2000mg | SAD: Change From Baseline in ECG Results by Time Point: QRS Interval | Change from baseline at 1h | 26.0 msec | Standard Deviation 6.9 |
| SAD Group II 2000mg | SAD: Change From Baseline in ECG Results by Time Point: QRS Interval | Change from BL at 24h post dose | 4.0 msec | Standard Deviation 0 |
| Group I Placebo + Food | SAD: Change From Baseline in ECG Results by Time Point: QRS Interval | Change from BL at 8h post dose | 0.0 msec | Standard Deviation 0 |
| Group I Placebo + Food | SAD: Change From Baseline in ECG Results by Time Point: QRS Interval | Change from baseline at 1h | 1.0 msec | Standard Deviation 1.4 |
| Group I Placebo + Food | SAD: Change From Baseline in ECG Results by Time Point: QRS Interval | Change from BL at 6h post dose | 1.0 msec | Standard Deviation 1.4 |
| Group I Placebo + Food | SAD: Change From Baseline in ECG Results by Time Point: QRS Interval | Change from BL at FU | -1.0 msec | Standard Deviation 4.2 |
| Group I Placebo + Food | SAD: Change From Baseline in ECG Results by Time Point: QRS Interval | Change from BL at 2h post dose | 0.0 msec | Standard Deviation 0 |
| Group I Placebo + Food | SAD: Change From Baseline in ECG Results by Time Point: QRS Interval | Change from BL at 12h post dose | 0.0 msec | Standard Deviation 0 |
| Group I Placebo + Food | SAD: Change From Baseline in ECG Results by Time Point: QRS Interval | Baseline (Pre-dose Day 1) | 95.0 msec | Standard Deviation 7.1 |
| Group I Placebo + Food | SAD: Change From Baseline in ECG Results by Time Point: QRS Interval | Change from BL at 24h post dose | -3.0 msec | Standard Deviation 4.2 |
| Group I Placebo + Food | SAD: Change From Baseline in ECG Results by Time Point: QRS Interval | Change from BL at 4h post dose | 0.0 msec | Standard Deviation 2.8 |
| Group I 100mg + Food | SAD: Change From Baseline in ECG Results by Time Point: QRS Interval | Change from baseline at 1h | 0.0 msec | Standard Deviation 2.8 |
| Group I 100mg + Food | SAD: Change From Baseline in ECG Results by Time Point: QRS Interval | Change from BL at 8h post dose | -0.5 msec | Standard Deviation 1.9 |
| Group I 100mg + Food | SAD: Change From Baseline in ECG Results by Time Point: QRS Interval | Change from BL at 2h post dose | -2.0 msec | Standard Deviation 2.8 |
| Group I 100mg + Food | SAD: Change From Baseline in ECG Results by Time Point: QRS Interval | Change from BL at 12h post dose | -2.5 msec | Standard Deviation 3 |
| Group I 100mg + Food | SAD: Change From Baseline in ECG Results by Time Point: QRS Interval | Change from BL at 4h post dose | -3.5 msec | Standard Deviation 3.4 |
| Group I 100mg + Food | SAD: Change From Baseline in ECG Results by Time Point: QRS Interval | Change from BL at 24h post dose | -1.0 msec | Standard Deviation 2 |
| Group I 100mg + Food | SAD: Change From Baseline in ECG Results by Time Point: QRS Interval | Baseline (Pre-dose Day 1) | 105.5 msec | Standard Deviation 8.3 |
| Group I 100mg + Food | SAD: Change From Baseline in ECG Results by Time Point: QRS Interval | Change from BL at FU | -1.5 msec | Standard Deviation 4.7 |
| Group I 100mg + Food | SAD: Change From Baseline in ECG Results by Time Point: QRS Interval | Change from BL at 6h post dose | -1.5 msec | Standard Deviation 3.4 |
Primary
SAD: Change From Baseline in ECG Results by Time Point: QTcB Interval
The baseline ECG recording consists of a triplicate recording (3 recordings of a least 3 complexes within a 5 minute window) prior to dosing on Day 1. For the evaluation the average of the 3 recordings will be taken as baseline.
Time frame: Pre-dose, Day1, Day 7
Population: Per protocol set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group I Placebo | SAD: Change From Baseline in ECG Results by Time Point: QTcB Interval | Change from BL at 24h post dose | 11.7 msec | Standard Deviation 19.3 |
| Group I Placebo | SAD: Change From Baseline in ECG Results by Time Point: QTcB Interval | Change from BL at 2h post dose | -0.5 msec | Standard Deviation 12.8 |
| Group I Placebo | SAD: Change From Baseline in ECG Results by Time Point: QTcB Interval | Baseline (Pre-dose Day 1) | 379.3 msec | Standard Deviation 21 |
| Group I Placebo | SAD: Change From Baseline in ECG Results by Time Point: QTcB Interval | Change from BL at 6h post dose | 12.7 msec | Standard Deviation 4.8 |
| Group I Placebo | SAD: Change From Baseline in ECG Results by Time Point: QTcB Interval | Change from BL at 12h post dose | 7.0 msec | Standard Deviation 8.3 |
| Group I Placebo | SAD: Change From Baseline in ECG Results by Time Point: QTcB Interval | Change from BL at 1h | 1.7 msec | Standard Deviation 7.7 |
| Group I Placebo | SAD: Change From Baseline in ECG Results by Time Point: QTcB Interval | Change from BL at 8h post dose | 3.0 msec | Standard Deviation 12.3 |
| Group I Placebo | SAD: Change From Baseline in ECG Results by Time Point: QTcB Interval | Change from BL at FU | 5.3 msec | Standard Deviation 17.6 |
| Group I Placebo | SAD: Change From Baseline in ECG Results by Time Point: QTcB Interval | Change from BL at 4h post dose | 5.5 msec | Standard Deviation 15.2 |
| Group II Placebo | SAD: Change From Baseline in ECG Results by Time Point: QTcB Interval | Change from BL at FU | 13.0 msec | Standard Deviation 15.4 |
| Group II Placebo | SAD: Change From Baseline in ECG Results by Time Point: QTcB Interval | Baseline (Pre-dose Day 1) | 385.5 msec | Standard Deviation 9.8 |
| Group II Placebo | SAD: Change From Baseline in ECG Results by Time Point: QTcB Interval | Change from BL at 4h post dose | -1.5 msec | Standard Deviation 17.1 |
| Group II Placebo | SAD: Change From Baseline in ECG Results by Time Point: QTcB Interval | Change from BL at 2h post dose | -2.8 msec | Standard Deviation 9.3 |
| Group II Placebo | SAD: Change From Baseline in ECG Results by Time Point: QTcB Interval | Change from BL at 1h | -0.7 msec | Standard Deviation 10.1 |
| Group II Placebo | SAD: Change From Baseline in ECG Results by Time Point: QTcB Interval | Change from BL at 24h post dose | 0.0 msec | Standard Deviation 8.6 |
| Group II Placebo | SAD: Change From Baseline in ECG Results by Time Point: QTcB Interval | Change from BL at 8h post dose | 1.2 msec | Standard Deviation 9.3 |
| Group II Placebo | SAD: Change From Baseline in ECG Results by Time Point: QTcB Interval | Change from BL at 12h post dose | 3.8 msec | Standard Deviation 8.9 |
| Group II Placebo | SAD: Change From Baseline in ECG Results by Time Point: QTcB Interval | Change from BL at 6h post dose | 3.7 msec | Standard Deviation 8.4 |
| SAD Group I 10mg | SAD: Change From Baseline in ECG Results by Time Point: QTcB Interval | Change from BL at 2h post dose | -4.0 msec | Standard Deviation 18.2 |
| SAD Group I 10mg | SAD: Change From Baseline in ECG Results by Time Point: QTcB Interval | Change from BL at 8h post dose | -4.8 msec | Standard Deviation 7.8 |
| SAD Group I 10mg | SAD: Change From Baseline in ECG Results by Time Point: QTcB Interval | Change from BL at FU | 4.8 msec | Standard Deviation 18.8 |
| SAD Group I 10mg | SAD: Change From Baseline in ECG Results by Time Point: QTcB Interval | Change from BL at 1h | -1.0 msec | Standard Deviation 2.8 |
| SAD Group I 10mg | SAD: Change From Baseline in ECG Results by Time Point: QTcB Interval | Baseline (Pre-dose Day 1) | 382.0 msec | Standard Deviation 21.4 |
| SAD Group I 10mg | SAD: Change From Baseline in ECG Results by Time Point: QTcB Interval | Change from BL at 24h post dose | 0.0 msec | Standard Deviation 11.3 |
| SAD Group I 10mg | SAD: Change From Baseline in ECG Results by Time Point: QTcB Interval | Change from BL at 4h post dose | -7.3 msec | Standard Deviation 3.3 |
| SAD Group I 10mg | SAD: Change From Baseline in ECG Results by Time Point: QTcB Interval | Change from BL at 12h post dose | -1.0 msec | Standard Deviation 2.2 |
| SAD Group I 10mg | SAD: Change From Baseline in ECG Results by Time Point: QTcB Interval | Change from BL at 6h post dose | 11.5 msec | Standard Deviation 5.8 |
| SAD Group II 30mg | SAD: Change From Baseline in ECG Results by Time Point: QTcB Interval | Change from BL at 2h post dose | -6.5 msec | Standard Deviation 7.9 |
| SAD Group II 30mg | SAD: Change From Baseline in ECG Results by Time Point: QTcB Interval | Change from BL at 12h post dose | -2.8 msec | Standard Deviation 14 |
| SAD Group II 30mg | SAD: Change From Baseline in ECG Results by Time Point: QTcB Interval | Change from BL at 4h post dose | -8.3 msec | Standard Deviation 11.9 |
| SAD Group II 30mg | SAD: Change From Baseline in ECG Results by Time Point: QTcB Interval | Change from BL at 6h post dose | 4.0 msec | Standard Deviation 13.1 |
| SAD Group II 30mg | SAD: Change From Baseline in ECG Results by Time Point: QTcB Interval | Change from BL at 1h | -0.3 msec | Standard Deviation 6.7 |
| SAD Group II 30mg | SAD: Change From Baseline in ECG Results by Time Point: QTcB Interval | Change from BL at FU | 10.8 msec | Standard Deviation 15.9 |
| SAD Group II 30mg | SAD: Change From Baseline in ECG Results by Time Point: QTcB Interval | Change from BL at 8h post dose | 6.8 msec | Standard Deviation 14.2 |
| SAD Group II 30mg | SAD: Change From Baseline in ECG Results by Time Point: QTcB Interval | Baseline (Pre-dose Day 1) | 390.5 msec | Standard Deviation 8.9 |
| SAD Group II 30mg | SAD: Change From Baseline in ECG Results by Time Point: QTcB Interval | Change from BL at 24h post dose | 0.8 msec | Standard Deviation 15.1 |
| SAD Group I 100mg | SAD: Change From Baseline in ECG Results by Time Point: QTcB Interval | Change from BL at 8h post dose | 8.5 msec | Standard Deviation 18.7 |
| SAD Group I 100mg | SAD: Change From Baseline in ECG Results by Time Point: QTcB Interval | Change from BL at 12h post dose | 2.8 msec | Standard Deviation 13 |
| SAD Group I 100mg | SAD: Change From Baseline in ECG Results by Time Point: QTcB Interval | Change from BL at FU | 8.3 msec | Standard Deviation 19.8 |
| SAD Group I 100mg | SAD: Change From Baseline in ECG Results by Time Point: QTcB Interval | Change from BL at 24h post dose | 3.0 msec | Standard Deviation 7.1 |
| SAD Group I 100mg | SAD: Change From Baseline in ECG Results by Time Point: QTcB Interval | Change from BL at 1h | -3.5 msec | Standard Deviation 5 |
| SAD Group I 100mg | SAD: Change From Baseline in ECG Results by Time Point: QTcB Interval | Change from BL at 6h post dose | 0.0 msec | Standard Deviation 14.9 |
| SAD Group I 100mg | SAD: Change From Baseline in ECG Results by Time Point: QTcB Interval | Change from BL at 2h post dose | -10.8 msec | Standard Deviation 9.6 |
| SAD Group I 100mg | SAD: Change From Baseline in ECG Results by Time Point: QTcB Interval | Change from BL at 4h post dose | -1.5 msec | Standard Deviation 7 |
| SAD Group I 100mg | SAD: Change From Baseline in ECG Results by Time Point: QTcB Interval | Baseline (Pre-dose Day 1) | 383.8 msec | Standard Deviation 24.8 |
| SAD Group II 300mg | SAD: Change From Baseline in ECG Results by Time Point: QTcB Interval | Change from BL at 6h post dose | 14.0 msec | Standard Deviation 11 |
| SAD Group II 300mg | SAD: Change From Baseline in ECG Results by Time Point: QTcB Interval | Baseline (Pre-dose Day 1) | 386.3 msec | Standard Deviation 8 |
| SAD Group II 300mg | SAD: Change From Baseline in ECG Results by Time Point: QTcB Interval | Change from BL at 1h | 1.8 msec | Standard Deviation 7.3 |
| SAD Group II 300mg | SAD: Change From Baseline in ECG Results by Time Point: QTcB Interval | Change from BL at 2h post dose | 3.0 msec | Standard Deviation 8.4 |
| SAD Group II 300mg | SAD: Change From Baseline in ECG Results by Time Point: QTcB Interval | Change from BL at 4h post dose | 6.0 msec | Standard Deviation 17.8 |
| SAD Group II 300mg | SAD: Change From Baseline in ECG Results by Time Point: QTcB Interval | Change from BL at 8h post dose | 5.5 msec | Standard Deviation 12.1 |
| SAD Group II 300mg | SAD: Change From Baseline in ECG Results by Time Point: QTcB Interval | Change from BL at 12h post dose | 11.5 msec | Standard Deviation 13.1 |
| SAD Group II 300mg | SAD: Change From Baseline in ECG Results by Time Point: QTcB Interval | Change from BL at 24h post dose | 1.5 msec | Standard Deviation 6.5 |
| SAD Group II 300mg | SAD: Change From Baseline in ECG Results by Time Point: QTcB Interval | Change from BL at FU | 13.3 msec | Standard Deviation 12.7 |
| SAD Group I 800mg | SAD: Change From Baseline in ECG Results by Time Point: QTcB Interval | Change from BL at 8h post dose | 8.0 msec | Standard Deviation 7.4 |
| SAD Group I 800mg | SAD: Change From Baseline in ECG Results by Time Point: QTcB Interval | Change from BL at 24h post dose | 5.3 msec | Standard Deviation 9 |
| SAD Group I 800mg | SAD: Change From Baseline in ECG Results by Time Point: QTcB Interval | Change from BL at 1h | 3.0 msec | Standard Deviation 8.6 |
| SAD Group I 800mg | SAD: Change From Baseline in ECG Results by Time Point: QTcB Interval | Change from BL at 12h post dose | 17.8 msec | Standard Deviation 5.2 |
| SAD Group I 800mg | SAD: Change From Baseline in ECG Results by Time Point: QTcB Interval | Change from BL at 2h post dose | 9.8 msec | Standard Deviation 8.3 |
| SAD Group I 800mg | SAD: Change From Baseline in ECG Results by Time Point: QTcB Interval | Change from BL at 4h post dose | 6.5 msec | Standard Deviation 6.2 |
| SAD Group I 800mg | SAD: Change From Baseline in ECG Results by Time Point: QTcB Interval | Change from BL at FU | -3.5 msec | Standard Deviation 6.5 |
| SAD Group I 800mg | SAD: Change From Baseline in ECG Results by Time Point: QTcB Interval | Baseline (Pre-dose Day 1) | 382.0 msec | Standard Deviation 10.9 |
| SAD Group I 800mg | SAD: Change From Baseline in ECG Results by Time Point: QTcB Interval | Change from BL at 6h post dose | 17.8 msec | Standard Deviation 1 |
| SAD Group II 2000mg | SAD: Change From Baseline in ECG Results by Time Point: QTcB Interval | Change from BL at 12h post dose | 36.0 msec | Standard Deviation 9.4 |
| SAD Group II 2000mg | SAD: Change From Baseline in ECG Results by Time Point: QTcB Interval | Baseline (Pre-dose Day 1) | 378.5 msec | Standard Deviation 19.1 |
| SAD Group II 2000mg | SAD: Change From Baseline in ECG Results by Time Point: QTcB Interval | Change from BL at 4h post dose | 38.5 msec | Standard Deviation 10.7 |
| SAD Group II 2000mg | SAD: Change From Baseline in ECG Results by Time Point: QTcB Interval | Change from BL at 6h post dose | 41.8 msec | Standard Deviation 13.8 |
| SAD Group II 2000mg | SAD: Change From Baseline in ECG Results by Time Point: QTcB Interval | Change from BL at FU | 9.0 msec | Standard Deviation 14.4 |
| SAD Group II 2000mg | SAD: Change From Baseline in ECG Results by Time Point: QTcB Interval | Change from BL at 8h post dose | 37.5 msec | Standard Deviation 19.3 |
| SAD Group II 2000mg | SAD: Change From Baseline in ECG Results by Time Point: QTcB Interval | Change from BL at 2h post dose | 41.3 msec | Standard Deviation 21.7 |
| SAD Group II 2000mg | SAD: Change From Baseline in ECG Results by Time Point: QTcB Interval | Change from BL at 1h | 39.0 msec | Standard Deviation 19 |
| SAD Group II 2000mg | SAD: Change From Baseline in ECG Results by Time Point: QTcB Interval | Change from BL at 24h post dose | 15.8 msec | Standard Deviation 4.9 |
| Group I Placebo + Food | SAD: Change From Baseline in ECG Results by Time Point: QTcB Interval | Change from BL at 8h post dose | 5.0 msec | Standard Deviation 12.7 |
| Group I Placebo + Food | SAD: Change From Baseline in ECG Results by Time Point: QTcB Interval | Change from BL at 1h | 12.5 msec | Standard Deviation 29 |
| Group I Placebo + Food | SAD: Change From Baseline in ECG Results by Time Point: QTcB Interval | Change from BL at 6h post dose | 20.0 msec | Standard Deviation 15.6 |
| Group I Placebo + Food | SAD: Change From Baseline in ECG Results by Time Point: QTcB Interval | Change from BL at FU | 9.0 msec | Standard Deviation 28.3 |
| Group I Placebo + Food | SAD: Change From Baseline in ECG Results by Time Point: QTcB Interval | Change from BL at 2h post dose | 4.5 msec | Standard Deviation 25.3 |
| Group I Placebo + Food | SAD: Change From Baseline in ECG Results by Time Point: QTcB Interval | Change from BL at 12h post dose | 17.5 msec | Standard Deviation 2.1 |
| Group I Placebo + Food | SAD: Change From Baseline in ECG Results by Time Point: QTcB Interval | Baseline (Pre-dose Day 1) | 367.5 msec | Standard Deviation 24.7 |
| Group I Placebo + Food | SAD: Change From Baseline in ECG Results by Time Point: QTcB Interval | Change from BL at 24h post dose | -0.5 msec | Standard Deviation 21.9 |
| Group I Placebo + Food | SAD: Change From Baseline in ECG Results by Time Point: QTcB Interval | Change from BL at 4h post dose | 9.0 msec | Standard Deviation 28.3 |
| Group I 100mg + Food | SAD: Change From Baseline in ECG Results by Time Point: QTcB Interval | Change from BL at 1h | 16.0 msec | Standard Deviation 7.9 |
| Group I 100mg + Food | SAD: Change From Baseline in ECG Results by Time Point: QTcB Interval | Change from BL at 8h post dose | 5.0 msec | Standard Deviation 6.5 |
| Group I 100mg + Food | SAD: Change From Baseline in ECG Results by Time Point: QTcB Interval | Change from BL at 2h post dose | 10.3 msec | Standard Deviation 4 |
| Group I 100mg + Food | SAD: Change From Baseline in ECG Results by Time Point: QTcB Interval | Change from BL at 12h post dose | 9.5 msec | Standard Deviation 10.3 |
| Group I 100mg + Food | SAD: Change From Baseline in ECG Results by Time Point: QTcB Interval | Change from BL at 4h post dose | 1.8 msec | Standard Deviation 8.2 |
| Group I 100mg + Food | SAD: Change From Baseline in ECG Results by Time Point: QTcB Interval | Change from BL at 24h post dose | -2.5 msec | Standard Deviation 5.7 |
| Group I 100mg + Food | SAD: Change From Baseline in ECG Results by Time Point: QTcB Interval | Baseline (Pre-dose Day 1) | 382.3 msec | Standard Deviation 22 |
| Group I 100mg + Food | SAD: Change From Baseline in ECG Results by Time Point: QTcB Interval | Change from BL at FU | 9.8 msec | Standard Deviation 18.5 |
| Group I 100mg + Food | SAD: Change From Baseline in ECG Results by Time Point: QTcB Interval | Change from BL at 6h post dose | 15.5 msec | Standard Deviation 6.6 |
Primary
SAD: Change From Baseline in ECG Results by Time Point: QT Interval
The baseline ECG recording consists of a triplicate recording (3 recordings of a least 3 complexes within a 5 minute window) prior to dosing on Day 1. For the evaluation the average of the 3 recordings will be taken as baseline.
Time frame: Pre-dose, Day 1, Day 7
Population: Per protocol set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group I Placebo | SAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from BL at 24h post dose | -6.7 msec | Standard Deviation 6.1 |
| Group I Placebo | SAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from BL at 2h post dose | 3.0 msec | Standard Deviation 8.5 |
| Group I Placebo | SAD: Change From Baseline in ECG Results by Time Point: QT Interval | Baseline (Pre-dose Day 1) | 400.0 msec | Standard Deviation 18.6 |
| Group I Placebo | SAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from BL at 6h post dose | -6.7 msec | Standard Deviation 8.8 |
| Group I Placebo | SAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from BL at 12h post dose | -8.7 msec | Standard Deviation 3.3 |
| Group I Placebo | SAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from baseline at 1h | 9.7 msec | Standard Deviation 12.7 |
| Group I Placebo | SAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from BL at 8h post dose | -8.7 msec | Standard Deviation 4.4 |
| Group I Placebo | SAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from BL at FU | -12.0 msec | Standard Deviation 4.3 |
| Group I Placebo | SAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from BL at 4h post dose | 9.3 msec | Standard Deviation 7.5 |
| Group II Placebo | SAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from BL at FU | -18.3 msec | Standard Deviation 11.4 |
| Group II Placebo | SAD: Change From Baseline in ECG Results by Time Point: QT Interval | Baseline (Pre-dose Day 1) | 415.0 msec | Standard Deviation 23.5 |
| Group II Placebo | SAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from BL at 4h post dose | -3.7 msec | Standard Deviation 16.9 |
| Group II Placebo | SAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from BL at 2h post dose | -7.3 msec | Standard Deviation 16.2 |
| Group II Placebo | SAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from baseline at 1h | -4.3 msec | Standard Deviation 13.6 |
| Group II Placebo | SAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from BL at 24h post dose | -23.0 msec | Standard Deviation 13.5 |
| Group II Placebo | SAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from BL at 8h post dose | -24.0 msec | Standard Deviation 9.9 |
| Group II Placebo | SAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from BL at 12h post dose | -24.3 msec | Standard Deviation 16.3 |
| Group II Placebo | SAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from BL at 6h post dose | -16.0 msec | Standard Deviation 14.8 |
| SAD Group I 10mg | SAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from BL at 2h post dose | 4.8 msec | Standard Deviation 21.4 |
| SAD Group I 10mg | SAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from BL at 8h post dose | -6.8 msec | Standard Deviation 9.1 |
| SAD Group I 10mg | SAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from BL at FU | -13.8 msec | Standard Deviation 6.7 |
| SAD Group I 10mg | SAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from baseline at 1h | 2.3 msec | Standard Deviation 6.4 |
| SAD Group I 10mg | SAD: Change From Baseline in ECG Results by Time Point: QT Interval | Baseline (Pre-dose Day 1) | 393.3 msec | Standard Deviation 15.4 |
| SAD Group I 10mg | SAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from BL at 24h post dose | -11.8 msec | Standard Deviation 3 |
| SAD Group I 10mg | SAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from BL at 4h post dose | 3.3 msec | Standard Deviation 9 |
| SAD Group I 10mg | SAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from BL at 12h post dose | -2.8 msec | Standard Deviation 9 |
| SAD Group I 10mg | SAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from BL at 6h post dose | -9.8 msec | Standard Deviation 8.5 |
| SAD Group II 30mg | SAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from BL at 2h post dose | 0.5 msec | Standard Deviation 9.7 |
| SAD Group II 30mg | SAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from BL at 12h post dose | -15.5 msec | Standard Deviation 11.2 |
| SAD Group II 30mg | SAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from BL at 4h post dose | 6.0 msec | Standard Deviation 7.1 |
| SAD Group II 30mg | SAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from BL at 6h post dose | -19.5 msec | Standard Deviation 7.4 |
| SAD Group II 30mg | SAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from baseline at 1h | -8.5 msec | Standard Deviation 9.5 |
| SAD Group II 30mg | SAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from BL at FU | -12.5 msec | Standard Deviation 9.8 |
| SAD Group II 30mg | SAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from BL at 8h post dose | -18.5 msec | Standard Deviation 4 |
| SAD Group II 30mg | SAD: Change From Baseline in ECG Results by Time Point: QT Interval | Baseline (Pre-dose Day 1) | 416.0 msec | Standard Deviation 15.6 |
| SAD Group II 30mg | SAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from BL at 24h post dose | -15.5 msec | Standard Deviation 16.5 |
| SAD Group I 100mg | SAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from BL at 8h post dose | -4.0 msec | Standard Deviation 16.6 |
| SAD Group I 100mg | SAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from BL at 12h post dose | -6.5 msec | Standard Deviation 13 |
| SAD Group I 100mg | SAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from BL at FU | -9.0 msec | Standard Deviation 5 |
| SAD Group I 100mg | SAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from BL at 24h post dose | -4.5 msec | Standard Deviation 8.2 |
| SAD Group I 100mg | SAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from baseline at 1h | 10.5 msec | Standard Deviation 5.3 |
| SAD Group I 100mg | SAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from BL at 6h post dose | -3.5 msec | Standard Deviation 13.2 |
| SAD Group I 100mg | SAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from BL at 2h post dose | 9.0 msec | Standard Deviation 10.9 |
| SAD Group I 100mg | SAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from BL at 4h post dose | 7.0 msec | Standard Deviation 12.9 |
| SAD Group I 100mg | SAD: Change From Baseline in ECG Results by Time Point: QT Interval | Baseline (Pre-dose Day 1) | 404.0 msec | Standard Deviation 11.4 |
| SAD Group II 300mg | SAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from BL at 6h post dose | -11.0 msec | Standard Deviation 6.2 |
| SAD Group II 300mg | SAD: Change From Baseline in ECG Results by Time Point: QT Interval | Baseline (Pre-dose Day 1) | 409.0 msec | Standard Deviation 28.2 |
| SAD Group II 300mg | SAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from baseline at 1h | -3.0 msec | Standard Deviation 7.4 |
| SAD Group II 300mg | SAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from BL at 2h post dose | -2.5 msec | Standard Deviation 6.6 |
| SAD Group II 300mg | SAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from BL at 4h post dose | -2.0 msec | Standard Deviation 11.4 |
| SAD Group II 300mg | SAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from BL at 8h post dose | -16.0 msec | Standard Deviation 9.8 |
| SAD Group II 300mg | SAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from BL at 12h post dose | -22.5 msec | Standard Deviation 6.8 |
| SAD Group II 300mg | SAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from BL at 24h post dose | -17.0 msec | Standard Deviation 14.7 |
| SAD Group II 300mg | SAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from BL at FU | -12.0 msec | Standard Deviation 13.4 |
| SAD Group I 800mg | SAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from BL at 8h post dose | -14.8 msec | Standard Deviation 9.3 |
| SAD Group I 800mg | SAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from BL at 24h post dose | -10.3 msec | Standard Deviation 13.3 |
| SAD Group I 800mg | SAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from baseline at 1h | -5.8 msec | Standard Deviation 17.6 |
| SAD Group I 800mg | SAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from BL at 12h post dose | -12.3 msec | Standard Deviation 7.5 |
| SAD Group I 800mg | SAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from BL at 2h post dose | 3.3 msec | Standard Deviation 17.1 |
| SAD Group I 800mg | SAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from BL at 4h post dose | -3.8 msec | Standard Deviation 16.7 |
| SAD Group I 800mg | SAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from BL at FU | -8.3 msec | Standard Deviation 12.4 |
| SAD Group I 800mg | SAD: Change From Baseline in ECG Results by Time Point: QT Interval | Baseline (Pre-dose Day 1) | 396.3 msec | Standard Deviation 15.9 |
| SAD Group I 800mg | SAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from BL at 6h post dose | -19.3 msec | Standard Deviation 9.2 |
| SAD Group II 2000mg | SAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from BL at 12h post dose | -13.3 msec | Standard Deviation 15.9 |
| SAD Group II 2000mg | SAD: Change From Baseline in ECG Results by Time Point: QT Interval | Baseline (Pre-dose Day 1) | 398.3 msec | Standard Deviation 17.3 |
| SAD Group II 2000mg | SAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from BL at 4h post dose | 1.8 msec | Standard Deviation 14.6 |
| SAD Group II 2000mg | SAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from BL at 6h post dose | -4.8 msec | Standard Deviation 16.3 |
| SAD Group II 2000mg | SAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from BL at FU | -7.8 msec | Standard Deviation 10.1 |
| SAD Group II 2000mg | SAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from BL at 8h post dose | -5.3 msec | Standard Deviation 7.1 |
| SAD Group II 2000mg | SAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from BL at 2h post dose | 4.8 msec | Standard Deviation 21.9 |
| SAD Group II 2000mg | SAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from baseline at 1h | 8.8 msec | Standard Deviation 22.7 |
| SAD Group II 2000mg | SAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from BL at 24h post dose | 2.3 msec | Standard Deviation 4.9 |
| Group I Placebo + Food | SAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from BL at 8h post dose | -17.0 msec | Standard Deviation 15.6 |
| Group I Placebo + Food | SAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from baseline at 1h | -11.0 msec | Standard Deviation 1.4 |
| Group I Placebo + Food | SAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from BL at 6h post dose | -14.0 msec | Standard Deviation 5.7 |
| Group I Placebo + Food | SAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from BL at FU | -2.0 msec | Standard Deviation 25.5 |
| Group I Placebo + Food | SAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from BL at 2h post dose | -2.0 msec | Standard Deviation 5.7 |
| Group I Placebo + Food | SAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from BL at 12h post dose | -18.0 msec | Standard Deviation 17 |
| Group I Placebo + Food | SAD: Change From Baseline in ECG Results by Time Point: QT Interval | Baseline (Pre-dose Day 1) | 373.0 msec | Standard Deviation 7.1 |
| Group I Placebo + Food | SAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from BL at 24h post dose | -3.0 msec | Standard Deviation 18.4 |
| Group I Placebo + Food | SAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from BL at 4h post dose | 7.0 msec | Standard Deviation 4.2 |
| Group I 100mg + Food | SAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from baseline at 1h | -15.5 msec | Standard Deviation 14.3 |
| Group I 100mg + Food | SAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from BL at 8h post dose | -9.0 msec | Standard Deviation 9.3 |
| Group I 100mg + Food | SAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from BL at 2h post dose | 16.0 msec | Standard Deviation 11.7 |
| Group I 100mg + Food | SAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from BL at 12h post dose | -10.0 msec | Standard Deviation 15.5 |
| Group I 100mg + Food | SAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from BL at 4h post dose | -4.0 msec | Standard Deviation 8.5 |
| Group I 100mg + Food | SAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from BL at 24h post dose | -7.0 msec | Standard Deviation 3.8 |
| Group I 100mg + Food | SAD: Change From Baseline in ECG Results by Time Point: QT Interval | Baseline (Pre-dose Day 1) | 396.0 msec | Standard Deviation 12.8 |
| Group I 100mg + Food | SAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from BL at FU | -1.0 msec | Standard Deviation 8.9 |
| Group I 100mg + Food | SAD: Change From Baseline in ECG Results by Time Point: QT Interval | Change from BL at 6h post dose | -13.0 msec | Standard Deviation 8.4 |
Primary
Terminal Elimination Half-life (T1/2) of KH176 Over 24 Hours: SAD
Plasma concentrations of KH176 were analysed after single dose administration of doses 10mg, 30mg, 100mg (with and without food), 300mg, 800mg, 2000mg b.i.d.
Time frame: Pre-dose (5 min before dosing) and 0.5, 1, 1.5, 2, 3, 6, 8, 12, and 24 hours post-dose
Population: Per protocol set
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Group I Placebo | Terminal Elimination Half-life (T1/2) of KH176 Over 24 Hours: SAD | 0 hours | Geometric Coefficient of Variation 0 |
| Group II Placebo | Terminal Elimination Half-life (T1/2) of KH176 Over 24 Hours: SAD | 10.3 hours | Geometric Coefficient of Variation 14.6 |
| SAD Group I 10mg | Terminal Elimination Half-life (T1/2) of KH176 Over 24 Hours: SAD | 9.10 hours | Geometric Coefficient of Variation 15.2 |
| SAD Group II 30mg | Terminal Elimination Half-life (T1/2) of KH176 Over 24 Hours: SAD | 9.64 hours | Geometric Coefficient of Variation 4.29 |
| SAD Group I 100mg | Terminal Elimination Half-life (T1/2) of KH176 Over 24 Hours: SAD | 9.80 hours | Geometric Coefficient of Variation 19.1 |
| SAD Group II 300mg | Terminal Elimination Half-life (T1/2) of KH176 Over 24 Hours: SAD | 11.5 hours | Geometric Coefficient of Variation 4.73 |
| SAD Group I 800mg | Terminal Elimination Half-life (T1/2) of KH176 Over 24 Hours: SAD | 9.09 hours | Geometric Coefficient of Variation 3.83 |
Primary
Terminal Elimination Half-life (T1/2) of KH183: SAD
Plasma concentrations of KH183 were analysed after single dose administration of doses 10mg, 30mg, 100mg (with and without food) , 300mg, 800mg, 2000mg b.i.d.
Time frame: Pre-dose (5 min before dosing) and 0.5, 1, 1.5, 2, 3, 6, 8, 12, and 24 hours post-dose
Population: Per protocol set
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Group I Placebo | Terminal Elimination Half-life (T1/2) of KH183: SAD | 16.6 hours | Geometric Coefficient of Variation 5.86 |
| Group II Placebo | Terminal Elimination Half-life (T1/2) of KH183: SAD | 17.8 hours | Geometric Coefficient of Variation 19 |
| SAD Group I 10mg | Terminal Elimination Half-life (T1/2) of KH183: SAD | 15.4 hours | Geometric Coefficient of Variation 8.44 |
| SAD Group II 30mg | Terminal Elimination Half-life (T1/2) of KH183: SAD | 14.3 hours | Geometric Coefficient of Variation 18.9 |
| SAD Group I 100mg | Terminal Elimination Half-life (T1/2) of KH183: SAD | 17.2 hours | Geometric Coefficient of Variation 18.5 |
| SAD Group II 300mg | Terminal Elimination Half-life (T1/2) of KH183: SAD | 18.9 hours | Geometric Coefficient of Variation 18.7 |
| SAD Group I 800mg | Terminal Elimination Half-life (T1/2) of KH183: SAD | 14.9 hours | Geometric Coefficient of Variation 7.86 |
Primary
Time to Maximum Concentration (Tmax) of KH176 at Day 1, Day 7: MAD Group
Plasma concentrations of KH176 were analysed after multiple-dose administration of doses of 100, 200 and 400 mg b.i.d.
Time frame: pre-dose at Day 1, 2, 4, 7, and post-dose at Day 1 and Day 7 at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours
Population: Per protocol set
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Group I Placebo | Time to Maximum Concentration (Tmax) of KH176 at Day 1, Day 7: MAD Group | Day 1 | 1.57 hours | Geometric Coefficient of Variation 173 |
| Group I Placebo | Time to Maximum Concentration (Tmax) of KH176 at Day 1, Day 7: MAD Group | Day 7 | 0.931 hours | Geometric Coefficient of Variation 48.1 |
| Group II Placebo | Time to Maximum Concentration (Tmax) of KH176 at Day 1, Day 7: MAD Group | Day 1 | 1.73 hours | Geometric Coefficient of Variation 16.7 |
| Group II Placebo | Time to Maximum Concentration (Tmax) of KH176 at Day 1, Day 7: MAD Group | Day 7 | 1.86 hours | Geometric Coefficient of Variation 14.5 |
| SAD Group I 10mg | Time to Maximum Concentration (Tmax) of KH176 at Day 1, Day 7: MAD Group | Day 1 | 0.866 hours | Geometric Coefficient of Variation 70.4 |
| SAD Group I 10mg | Time to Maximum Concentration (Tmax) of KH176 at Day 1, Day 7: MAD Group | Day 7 | 1.36 hours | Geometric Coefficient of Variation 85.5 |
Primary
Time to Maximum Concentration (Tmax) of KH176 Over 24 Hours: SAD
Plasma concentrations of KH176 were analysed after single dose administration of doses 10mg, 30mg, 100mg (with and without food), 300mg, 800mg, 2000mg b.i.d.
Time frame: Pre-dose (5 min before dosing) and 0.5, 1, 1.5, 2, 3, 6, 8, 12, and 24 hours post-dose
Population: Per protocol set
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Group I Placebo | Time to Maximum Concentration (Tmax) of KH176 Over 24 Hours: SAD | 1.03 hours | Geometric Coefficient of Variation 55.5 |
| Group II Placebo | Time to Maximum Concentration (Tmax) of KH176 Over 24 Hours: SAD | 1.03 hours | Geometric Coefficient of Variation 55.5 |
| SAD Group I 10mg | Time to Maximum Concentration (Tmax) of KH176 Over 24 Hours: SAD | 0.931 hours | Geometric Coefficient of Variation 83.4 |
| SAD Group II 30mg | Time to Maximum Concentration (Tmax) of KH176 Over 24 Hours: SAD | 1.10 hours | Geometric Coefficient of Variation 85.6 |
| SAD Group I 100mg | Time to Maximum Concentration (Tmax) of KH176 Over 24 Hours: SAD | 1.36 hours | Geometric Coefficient of Variation 20.5 |
| SAD Group II 300mg | Time to Maximum Concentration (Tmax) of KH176 Over 24 Hours: SAD | 0.931 hours | Geometric Coefficient of Variation 102 |
| SAD Group I 800mg | Time to Maximum Concentration (Tmax) of KH176 Over 24 Hours: SAD | 2.45 hours | Geometric Coefficient of Variation 23.7 |
Primary
Time to Maximum Concentration (Tmax) of KH183 (Active Metabolite of KH176): MAD Group
Plasma concentrations of KH183 were analysed after multiple-dose administration of doses of 100, 200 and 400 mg b.i.d.. tmax was obtained directly from the concentration-time data.
Time frame: Predose at Day 1, 2, 4, 7, and post-dose at Day 1 and Day 7 at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours
Population: Per protocol set
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Group I Placebo | Time to Maximum Concentration (Tmax) of KH183 (Active Metabolite of KH176): MAD Group | Day 1 | 2.06 hours | Geometric Coefficient of Variation 116 |
| Group I Placebo | Time to Maximum Concentration (Tmax) of KH183 (Active Metabolite of KH176): MAD Group | Day 7 | 1.19 hours | Geometric Coefficient of Variation 36.6 |
| Group II Placebo | Time to Maximum Concentration (Tmax) of KH183 (Active Metabolite of KH176): MAD Group | Day 1 | 1.57 hours | Geometric Coefficient of Variation 33.7 |
| Group II Placebo | Time to Maximum Concentration (Tmax) of KH183 (Active Metabolite of KH176): MAD Group | Day 7 | 1.46 hours | Geometric Coefficient of Variation 29.1 |
| SAD Group I 10mg | Time to Maximum Concentration (Tmax) of KH183 (Active Metabolite of KH176): MAD Group | Day 1 | 1.22 hours | Geometric Coefficient of Variation 23.7 |
| SAD Group I 10mg | Time to Maximum Concentration (Tmax) of KH183 (Active Metabolite of KH176): MAD Group | Day 7 | 1.61 hours | Geometric Coefficient of Variation 48.1 |
Primary
Time to Reach Peak Plasma Concentration (Tmax) of KH183: SAD
Plasma concentrations of KH183 were analysed after single dose administration of doses 10mg, 30mg, 100mg (with and without food), 300mg, 800mg, 2000mg b.i.d.
Time frame: Pre-dose (5 min before dosing) and 0.5, 1, 1.5, 2, 3, 6, 8, 12, and 24 hours post-dose
Population: Per protocol set
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Group I Placebo | Time to Reach Peak Plasma Concentration (Tmax) of KH183: SAD | 1.32 ng/mL | Geometric Coefficient of Variation 34.8 |
| Group II Placebo | Time to Reach Peak Plasma Concentration (Tmax) of KH183: SAD | 1.46 ng/mL | Geometric Coefficient of Variation 29.1 |
| SAD Group I 10mg | Time to Reach Peak Plasma Concentration (Tmax) of KH183: SAD | 1.32 ng/mL | Geometric Coefficient of Variation 34.8 |
| SAD Group II 30mg | Time to Reach Peak Plasma Concentration (Tmax) of KH183: SAD | 1.31 ng/mL | Geometric Coefficient of Variation 34.7 |
| SAD Group I 100mg | Time to Reach Peak Plasma Concentration (Tmax) of KH183: SAD | 1.61 ng/mL | Geometric Coefficient of Variation 14.5 |
| SAD Group II 300mg | Time to Reach Peak Plasma Concentration (Tmax) of KH183: SAD | 1.57 ng/mL | Geometric Coefficient of Variation 33.7 |
| SAD Group I 800mg | Time to Reach Peak Plasma Concentration (Tmax) of KH183: SAD | 2.45 ng/mL | Geometric Coefficient of Variation 23.7 |