IBD (Inflammatory Bowel Disease)
Conditions
Brief summary
A Phase Ⅰ, Single and Multiple Ascending Dose escalation, and Food-Effect Study of the Safety, Tolerability and Pharmacokinetics of INT-210 Capsules in Healthy Adult Voluteers. Primary Objectives: ● To assess the safety and tolerability of single and multiple oral dose of INT-210 capsules in healthy adult voluteers, Secondary Objectives: * To assess the pharmacokinetic(PK) profile of single and multiple oral doses of INT-210 capsules in healthy adult voluteers; * To assess the safety and tolerability of INT-210 capsulese administered under fasting and fed(high-fat-meal) conditions in healthy adult voluteers; * To assess the effect of food on the PK profile of a single oral dose of INT-210 capsules in healthy adult voluteers;
Interventions
DRUGINT-210 Capsule
400 mg INT-210; Oral administration
DRUGINT-210 Placebo
INT-210 Placebo BID
Sponsors
Innatus Therapeutics (Shanghai) Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female healthy voluteers * Aged 18-45 years(inclusive), * In good general health with no evidence of active or chronic disease; and who agree to comply with the prescribed contraceptive requirement during the trial and for 3 months after the last dose.
Exclusion criteria
* Female who are pregnant or breastfeeding; or planing pregnancy, female of chidbearing potential not using adequate contraception. * Pre-existing significant medical conditions(cardiac, hepatic, renal, gastrointestina, etc), abnormal lab results, active infection, or history of special conditions like long QT syndrome or hypocalcemia. * Positive screening for HIV, Hepatitis B/C or syphilis; * Recent subject in another clinical trial; * Recent major surgery, or significant blood loss.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of treatment-emergent adverse events | From Day 1 through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD) | Number of participants with treatment-related adverse events as assessed. The incidence of treatment-emergent adverse events will be measured using a combination of data collection methods, including tracking adverse events and assessing their onset or worsening relative to the initiation of treatment. The most recent version of the Medical Dictionary for Regulatory Activities (MedDRA) preferred terms will be used to classify adverse events, including their relationship to the treatment and maximum severity. |
| Treatment-emergent potentially clinically- significant abnormalities in safety laboratory parameters-hematology | From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD) | Hemoglobin, Hematocrit, Erythrocytes, Mean corpuscular volume, Platelets, Leukocytes, Eosinophils, Basophils, Neutrophils, Lymphocytes, Monocytes |
| Treatment-emergent potentially clinically significant abnormalities in safety laboratory parameters: coagulation | From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD) | Activated partial thromboplastin time, Prothrombin time, International Normalized Ratio, Fibrinogen |
| Treatment-emergent potentially clinically significant abnormalities in safety laboratory parameters: serum chemistry | From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD) | Glucose, Blood urea nitrogen, Creatinine, Sodium, Potassium, Calcium, Chloride, Magnesium, Bicarbonate, Phosphate, Bilirubin, total and direct, Alkaline phosphatase, Aspartate transaminase (=SGOT), Alanine transaminase (=SGPT), Gamma glutamyl transferase, Total protein, Albumin, Creatine kinase, Lactate dehydrogenase (LDH) |
| Treatment-emergent potentially clinically significant abnormalities in safety laboratory parameters: urinalysis | From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD) | Specific gravity, PH, Glucose, Protein, Nitrite , Urobilinogen, Occult Blood, White blood cells, Ketones, Red blood cells |
| Treatment-emergent potentially clinically significant abnormalities in electrocardiogram values: QTcF (milliseconds) | From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD) | ECG assessment (QTcF) as determined by the Investigator/consulting board-certified cardiologist |
| Treatment-emergent potentially clinically significant abnormalities in vital signs: heart rate (beats per minute) | From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD) | — |
| Treatment-emergent potentially clinically significant abnormalities in vital signs: blood pressure (mmHg) | From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD) | — |
| Treatment-emergent potentially clinically significant abnormalities in vital signs: respiration rate (BPM) | From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD) | — |
| Treatment-emergent potentially clinically significant abnormalities in vital signs: hemoglobin saturation (%) | From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD) | — |
| Treatment-emergent potentially clinically significant abnormalities in vital signs: temperature (℃) | From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD) | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics parameter: Cmax of INT-210 | SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11 | Maximum observed plasma concentration (ng/mL) |
| Pharmacokinetics parameter: Tmax of INT-210 | SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11 | Time of maximum observed concentration (Tmax) of INT-210 |
| Pharmacokinetics parameter: AUC (0-T) of INT-210 | SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11 | Area Under the concentration-time curve from dosing to the time of the last measured concentration (AUC0-T) (h\*ng/L) of INT-210 |
| Pharmacokinetics parameter: T1/2 of INT-210 | SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11 | Half-life (T1/2) (hours) of INT-210 |
| Pharmacokinetics parameter: CL/F of INT-210 | SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11 | Apparent clearance (L/h) of INT-210 |
| Pharmacokinetics parameter: Vz/F of INT-210 | SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11 | Apparent volume of distribution (L) of INT-210 |
| Pharmacokinetics parameter: AUCinf of INT-210 | SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11 | Area under the curve from time 0 extrapolated to infinite time (AUCinf) (h\*ng/L) of INT-210 |
Countries
China
Outcome results
None listed