Hepatitis B, Chronic
Conditions
Brief summary
This sponsor-open, investigator- and participant-blinded, multi-center study will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of RO7020531 in healthy participants and in participants with chronic hepatitis B. Part I will be conducted in two portions: Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) which will include only healthy volunteers. Part II will commence after completion of the MAD portion of Part I and will include only Chronic Hepatitis B (CHB) participants.
Interventions
OTHERPlacebo
Placebo matching to RO7020531 will be administered as per schedule specified in the respective arm.
DRUGRO7020531
RO7020531 will be administered as per schedule specified in the respective arm.
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Part 1: SAD and MAD in Healthy Volunteers * Non-smokers, or use of less than (\<) 10 cigarettes (or equivalent nicotine-containing product) per day * Negative Anti-Nuclear Antibody (ANA) test; or positive with dilutions not greater than 1:40 and with no associated history or symptoms of potential connective tissue disease or other immune-mediated diseases Part 2: CHB Participants * CHB infection (positive test for Hepatitis B surface antigen \[HBsAg\] for more than 6 months prior to randomization) * For Cohort 1, 2, 3 and 4: HBsAg detectable at screening * For Cohort 1, 2 and 3: Hepatitis B virus deoxyribose nuclic acid (HBV DNA) \< 90 international unit per milliliter (IU/mL) for at least 6 months prior to randomization; HBV DNA \< 90 IU/mL at screening by Roche Cobas assay * For Cohort 4: HBV DNA at screening \>= 2 × 10\*4 IU/mL for HBeAg positive and \>= 2 x 10\*3 IU/mL for hepatitis B e antigen (HBeAg) negative participants * For Cohort 1, 2 and 3: Alanine amino transferase (ALT) =\<1.5 × upper limit of normal (ULN) during the 6 months prior to randomization confirmed by two measurements separated by at least 14 days; ALT at screening =\< 1.5 × ULN. * For Cohort 4: ALT and aspartate aminotransferase (AST) at screening and Day -1 visit: =\< 5 × ULN. * Negative ANA test; or positive with dilutions not greater than 1:40 and with no associated history or symptoms of potential connective tissue disease or other immune-mediated diseases * Liver biopsy, Fibroscan® or equivalent elastography test obtained within 6 months prior to randomization demonstrating liver disease consistent with chronic HBV infection with absence of cirrhosis and absence of extensive bridging fibrosis (cirrhosis or extensive bridging fibrosis are defined as greater than or equal to (\>/=) Metavir 3, recommended cut-off for Fibroscan 8.5 kilopascals \[kPa\]) * For Cohort 1, 2 and 3: On treatment with tenofovir, entecavir, adefovir, or telbivudine, either as single agents or in combination, for at least 6 months * For Cohort 4: Hepatitis B virus (HBV) treatment naïve or not on any anti-HBV treatment for the past 6 months
Exclusion criteria
Part 1: SAD and MAD in Healthy Volunteers * History of immunologically mediated disease (e.g., inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune haemolytic anemia, scleroderma, severe psoriasis, rheumatoid arthritis, multiple sclerosis, or any other autoimmune disease); clinically significant psychiatric disease, acute infection (e.g., influenza), gastrointestinal (GI) disease (including inflammatory bowel disease, peptic ulcer disease, GI hemorrhage) * History of having received or currently receiving any systemic anti-neoplastic (including radiation) or immune-modulatory treatment (including systemic oral or inhaled corticosteroids, IFN or pegylated interferon \[PEG-IFN\]) within the 8 weeks prior to the first dose of study drug or the expectation that such treatment will be needed at any time during the study * Any clinically significant concomitant disease or condition that could interfere with, or for which the treatment of might interfere with, the conduct of the study, or that would, in the opinion of the Investigator, pose an unacceptable risk to the participant in this study * Positive Hepatitis A virus antibody (HAV Ab IgM), HBsAg, Hepatitis C antibody (HCV Ab), or positive for human immunodeficiency virus (HIV) at screening * History of clinically significant thyroid disease; also, participants with clinically significant elevated thyroid-stimulating hormone (TSH) concentrations at screening * Positive results for anti-mitochondrial antibody (AMA), anti-smooth muscle antibody (ASMA) or thyroid peroxidase antibody Part 2: CHB Participants * History of liver cirrhosis * History or other evidence of bleeding from esophageal varices * Decompensated liver disease (e.g., Child-Pugh Class B or C clinical classification or clinical evidence such as ascites or varices) * History or other evidence of a medical condition associated with chronic liver disease other than HBV infection (e.g., hemochromatosis, autoimmune hepatitis, alcoholic liver disease, toxin exposure, thalassemia, nonalcoholic steato-hepatitis, etc.). A clinical diagnosis of fatty liver is allowed provided that non alcoholic steatohepatitis (NASH) has been excluded by liver biopsy. * Documented history or other evidence of metabolic liver disease within one year of randomization * Positive test for Hepatitis A virus (IgM anti-HAV), Hepatitis C virus (HCV), Hepatitis D virus, Hepatitis E virus (HEV), or human immunodeficiency virus (HIV). * History of or suspicion of hepatocellular carcinoma or alpha fetoprotein \>/=13 nanograms per milliliter (ng/mL) at screening * History of immunologically mediated disease (e.g., inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune haemolytic anemia, scleroderma, severe psoriasis, rheumatoid arthritis, multiple sclerosis, or any other autoimmune disease); clinically significant psychiatric disease; acute infection (e.g., influenza); GI disease (including inflammatory bowel disease, peptic ulcer disease, GI hemorrhage, or history of pancreatitis); clinically significant cardiovascular (including postural hypotension), endocrine, renal, ocular, pulmonary or neurological disease. * History of having received or currently receiving any systemic anti-neoplastic (including radiation) or immune-modulatory treatment (including systemic oral or inhaled corticosteroids,IFN or PEG-IFN) within the 8 weeks prior to the first dose of study drug or the expectation that such treatment will be needed at any time during the study * Cohort 4: Concurrent HBV treatments * History of organ transplantation * Clinically significant thyroid disease; also, participants with clinically significant elevated TSH concentrations at screening * Positive results for AMA, ASMA or thyroid peroxidase antibody
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part 1: Percentage of SAD Participants With Adverse Events (AEs) | From randomization up to Day 29 | An AE is any untoward medical occurrence in a clinical investigation healthy volunteer (HV)/participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product, any new disease or exacerbation of an existing disease (a worsening in the character, frequency, or severity of a known condition and recurrence of an intermittent medical condition (e.g., headache) not present at baseline. |
| Part 1: Percentage of MAD Participants With AEs | From randomization up to Day 41 | An AE is any untoward medical occurrence in a clinical investigation healthy volunteer (HV)/participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product, any new disease or exacerbation of an existing disease (a worsening in the character, frequency, or severity of a known condition and recurrence of an intermittent medical condition (e.g., headache) not present at baseline. |
| Part 2: Percentage of Chronic Hepatitis B Participants With AEs | From randomization up to Week 12 | An AE is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product, any new disease or exacerbation of an existing disease (a worsening in the character, frequency, or severity of a known condition and recurrence of an intermittent medical condition (e.g., headache) not present at baseline. |
| Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | From randomization up to Day 8 | For all laboratory parameters included, there exists a Roche predefined standard reference range. Laboratory values falling outside this standard reference range were labeled H for high or L for low in HV/participant listings of laboratory data. |
| Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | From randomization up to Day 20 | For all laboratory parameters included, there exists a Roche predefined standard reference range. Laboratory values falling outside this standard reference range were labeled H for high or L for low in HV/participant listings of laboratory data. |
| Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | From randomization up to Week 12 | For all laboratory parameters included, there exists a Roche predefined standard reference range. Laboratory values falling outside this standard reference range were labeled H for high or L for low in HV/participant listings of laboratory data. |
| Part 1: Percentage of SAD Participants With Abnormalities in Electrocardiograph (ECG) Parameters | From randomization up to Day 8 | Triplicate 12-lead ECGs were obtained after the participant has been in a supine position for at least 10 minutes. Clinically significant RO7020531-related changes included confirmation of mean QTc 500 milliseconds (msec) or 60 msec longer than the pre-dose baseline. |
| Part 1: Percentage of MAD Participants With Abnormalities in ECG Parameters | From randomization up to Day 20 | Triplicate 12-lead ECGs were obtained after the participants has been in a supine position for at least 10 minutes. Clinically significant RO7020531-related changes included confirmation of mean QTc 500 msec or 60 msec longer than the pre-dose baseline. |
| Part 2: Percentage of Chronic Hepatitis B Participants With Abnormalities in ECG Parameters | From randomization up to Week 12 | Triplicate 12-lead ECGs were obtained after the participant has been in a supine position for at least 10 minutes. Clinically significant RO7020531-related changes included confirmation of mean QTc 500 msec or 60 msec longer than the pre-dose baseline. |
| Part 1: Percentage of SAD Participants With Abnormalities in Vital Signs | From randomization up to Day 8 | Vital signs include blood pressure, pulse rate, respiratory rate and body temperature. Blood pressure, respiratory rate and pulse rate were obtained after the participant had been in a supine or sitting position for at least 5 minutes. Blood pressure measurement were performed in triplicate (can be as short as 20 second to 1 minute interval between measurements). |
| Part 1: Percentage of MAD Participants With Abnormalities in Vital Signs | From randomization up to Day 20 | Vital signs include blood pressure, pulse rate, respiratory rate and body temperature. Blood pressure, respiratory rate and pulse rate were obtained after the participant had been in a supine or sitting position for at least 5 minutes. Blood pressure measurement were performed in triplicate (can be as short as 20 second to 1 minute interval between measurements). |
| Part 2: Percentage of Chronic Hepatitis B Participants With Abnormalities in Vital Signs | From randomization up to Week 12 | Vital signs include blood pressure, pulse rate, respiratory rate and body temperature. Blood pressure, respiratory rate and pulse rate were obtained after the participant had been in a supine or sitting position for at least 5 minutes. Blood pressure measurement were performed in triplicate (can be as short as 20 second to 1 minute interval between measurements). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Part 2: Mean Concentration of IFN-alpha | Predose, 6, 8 and 24 hrs Postdose on Day 1; Predose, 4-6, 24 hrs Postdose on Days 3, 7 and 21; Predose, 6, 24 hrs Postdose on Day 41 | Mean concentrations of IFN-alpha for Part 2 were calculated following multiple doses. The SD presented is actually the log transformed geometric standard deviation. |
| Part 1: Mean Fold Change From Baseline in Cytokine Markers: SAD and MAD | SAD: Predose, 2, 6, 12, 24, 48 (only Neopterin) and 96 hrs (only Neopterin) Postdose; MAD: Predose, 2, 6, 12, and 24 hrs Postdose on Day 1; Predose, 2, 6 and 24 hrs Postdose on Days 3, 5, 7, 13 and 20 | Cytokines markers include Chemokine (C-X-C Motif) Ligand 10 (IP-10), Interleukin 6 (IL-6), Interleukin 10 (IL-10), Interleukin 12 p40 (IL-12 p40), Neopterin, Tumor Necrosis Factor-Alpha (TNF-alpha). The SD presented is actually the log transformed geometric standard deviation. |
| Part 2: Mean Fold Change From Baseline in Cytokine Markers | Predose, 6, 8 and 24 hrs Postdose on Day 1; Predose, 4-6, 24 hrs Postdose on Days 3, 7 and 21; Predose, 6, 24 hrs Postdose on Day 41 | Cytokines markers included IP- 10, IL- 6, IL-1 10, IL-12 p40, Neopterin and TNF -alpha. The SD presented is actually the log transformed geometric standard deviation. |
| Part 2: Cmax of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805 | Predose and 0.25, 1, 2, 4, 6, 8, and 24 hours post dose on Days 1 and 41 | — |
| Part 2: Mean Fold Change From Baseline in Markers of Transcriptional Responses | Predose, 6, 8, 24 hrs postdose on Day 1; Predose, 4-6, 24 hrs postdose on Days 3, 7, 21; Predose, 6, 24 hrs postdose on Day 41 | Transcriptional markers include mRNA ISG15, mRNA OAS1, mRNA MX-1, mRNA TLR7. The SD presented is actually the log transformed geometric standard deviation. |
| Effect of RO7020531 Dosing on ECG Parameters (PR [PQ], QRS, QT, QTcF in Miliseconds [ms]) Using Exposure-response Analysis: SAD and MAD | SAD: Predose, 0.5, 1, 2, 4, 6, 12, 24 and 48 hrs Post dose on Day 1; MAD: Predose, 0.5, 1,2,4 and 12 hrs Postdose on Day 1 and 13; Predose, 2 and 6 hrs Postdose on Day 3, Predose, 6 and 24 hrs Postdose on Day , 7, 9, and 11 | — |
| Part 2: Plasma Concentrations of Tenofovir, Tenofovir Alafenamide, Entecavir, Adefovir and Telbivudine | Pre-dose and 2-4 hours post-dose on Day 1, Day 21 and Day 41 | Adefovir was not administered to any participants in the study. Hence, no data could be collected for plasma concentration of adefovir. As participants in each cohort received different NUCs the data for Cohorts 1, 2 and 3 have been reported separately. |
| Part 1:Mean Fold Change From Baseline in Markers of Transcriptional Responses: SAD and MAD | SAD: Predose, 2, 6, 12 and 24 Postdose; MAD: Predose, 2, 6, 12, and 24 hrs Postdose on Day 1; Predose, 2, 6 and 24 hrs Postdose on Days 3, 5, 7, 13 and 20 | Markers of transcriptional responses includes messenger ribonucleic acid interferon-stimulated gene 15(mRNA ISG15), messenger RNA oligoadenylate synthetase 1 (mRNA OAS1), messenger RNA myxovirus resistance 1 gene (mRNA MX-1), messenger RNA Toll-like receptor (mRNA TLR7). The SD presented is actually the log transformed geometric standard deviation. |
| Part 1: Maximum Observed Plasma Concentration (Cmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | SAD: Predose and 0.5, 1, 1.5 , 2, 3, 4, 6,8, 12,18, and 24hours post dose on Day 1; MAD: Predose and 0.25, 0.5, 1, 1.5, 2 , 3, 4, 6, 8, 12,18, and 24 hours post dose on Days 1 and 13 | — |
| Part 1: Time to Maximum Observed Plasma Concentration (Tmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | SAD: Predose and 0.5, 1, 1.5 , 2, 3, 4, 6,8, 12,18, and 24hours post dose on Day 1; MAD: Predose and 0.25, 0.5, 1, 1.5, 2 , 3, 4, 6, 8, 12,18, and 24 hours post dose on Days 1 and 13 | — |
| Part 2: Tmax of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805 | Predose and 0.25, 1, 2, 4, 6, 8, and 24 hours post dose on Days 1 and 41 | — |
| Part 1: Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUCinf) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | SAD: Predose and 0.5, 1, 1.5 , 2, 3, 4, 6,8, 12,18, and 24hours post dose on Day 1; MAD: Predose and 0.25, 0.5, 1, 1.5, 2 , 3, 4, 6, 8, 12,18, and 24 hours post dose on Days 1 and 13 | — |
| Part 2: AUCinf of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805 | Predose and 0.25, 1, 2, 4, 6, 8, and 24 hours post dose on Days 1 and 41 | — |
| Part 1: Area Under the Plasma Concentration Versus Time Curve up to the Last Measurable Concentration (AUClast) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | SAD: Predose and 0.5, 1, 1.5 , 2, 3, 4, 6,8, 12,18, and 24hours post dose on Day 1; MAD: Predose and 0.25, 0.5, 1, 1.5, 2 , 3, 4, 6, 8, 12,18, and 24 hours post dose on Days 1 and 13 | — |
| Part 2: AUClast of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805 | Predose and 0.25, 1, 2, 4, 6, 8, and 24 hours post dose on Days 1 and 41 | — |
| Part 1: Half Life (t1/2) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | SAD: Predose and 0.5, 1, 1.5 , 2, 3, 4, 6,8, 12,18, and 24hours post dose on Day 1; MAD: Predose and 0.25, 0.5, 1, 1.5, 2 , 3, 4, 6, 8, 12,18, and 24 hours post dose on Days 1 and 13 | — |
| Part 2: t1/2 of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805 | Predose and 0.25, 1, 2, 4, 6, 8, and 24 hours post dose on Days 1 and 41 | — |
| Part 1: Total Amount of RO7020531, RO7011785, RO7018822 and RO7033805 in Urine: SAD | 0 to 24 hrs Postdose on Day 1 | Total amount of the study drug and metabolites recovered in urine was reported. |
| Part 1:Mean Concentration of Interferon Alpha (IFN-alpha): SAD and MAD | SAD: Predose, 2, 6, 12 and 24 hrs Postdose; MAD: Predose, 2, 6, 12, and 24 hrs Postdose on Day 1; Predose, 2, 6 and 24 hrs Postdose on Days 3, 5, 7, 13 and 20 | Mean concentrations of IFN-alpha for SAD were calculated following single-dose and for MAD it was calculated following multiple doses. The standard deviation (SD) presented is actually the log transformed geometric standard deviation. |
Countries
Bulgaria, Hong Kong, Italy, Netherlands, New Zealand, Taiwan, Thailand, United Kingdom
Participant flow
Recruitment details
Participants were enrolled at 16 investigative sites in New Zealand, Hong Kong, Thailand, Taiwan, New Zealand, Bulgaria, United Kingdom, Italy and Netherlands from 12 December 2016 to 15 June 2021.
Pre-assignment details
A total of 160 participants were enrolled in the study. 110 participants were enrolled in Part 1 and 50 participants were enrolled in Part 2.
Participants by arm
| Arm | Count |
|---|---|
| Part 1 Cohorts 1-8 SAD: Placebo In SAD Cohorts 1-8, sixteen HVs, two in each cohort, received a single dose of RO7020531 matching placebo, on Day 1. | 16 |
| Part 1 SAD: Cohort 1 HVs received single dose of RO7020531, 3 mg, orally on Day 1. | 8 |
| Part 1 SAD: Cohort 2 HVs received single dose of RO7020531, 10 mg, orally on Day 1. | 8 |
| Part 1 SAD: Cohort 3 HVs received single dose of RO7020531, 20 mg, orally on Day 1. | 8 |
| Part 1 SAD: Cohort 4 HVs received single dose of RO7020531, 40 mg, orally on Day 1. | 8 |
| Part 1 SAD: Cohort 5 HVs received single dose of RO7020531, 60 mg, orally on Day 1. | 8 |
| Part 1 SAD: Cohort 6 HVs received single dose of RO7020531, 100 mg, orally on Day 1. | 8 |
| Part 1 SAD: Cohort 7 HVs received single dose of RO7020531, 140 mg, orally on Day 1. | 8 |
| Part 1 SAD: Cohort 8 HVs received single dose of RO7020531, 170 mg, orally on Day 1. | 8 |
| Part 1 Cohorts 1-3, MAD: Placebo In MAD Cohorts 1,2, and 3, six HVs, two in each cohort, received RO7020531 matching placebo orally on Day 1 and QOD for 13 days. | 6 |
| Part 1 MAD: Cohort 1 HVs received RO7020531, 100 mg, orally, on Day 1 and QOD for 13 days. | 8 |
| Part 1 MAD: Cohort 2 HVs received RO7020531, 140 mg, orally, on Day 1 and QOD for 13 days. | 8 |
| Part 1 MAD: Cohort 3 HVs received RO7020531, 170 mg, orally, on Day 1 and QOD for 13 days. | 8 |
| Part 2 Cohorts 1-3: Placebo In Cohorts 1,2, and 3, six participants, two in each cohort, Participants received RO7020531 matching placebo, along with NUC treatment, orally, on Day 1 and QOD for 41 days. | 6 |
| Part 2: Cohort 1 and 2 Sixteen participants received RO7020531, 150 mg, along with NUC treatment, orally, on Day 1 and QOD for 41 days. Cohorts 1 and 2 were both 150 mg cohorts and was presented as a single dose group. | 16 |
| Part 2: Cohort 3 Participants received RO7020531, 170 mg, along with NUC treatment, orally, on Day 1 and QOD for 41 days. | 8 |
| Part 2 Cohort 4: Placebo Treatment naive participants received RO7020531 matching placebo, orally, on Day 1 and QOD for 41 days. | 5 |
| Part 2: Cohort 4 Treatment naive participants received RO7020531, 150 mg, orally, on Day 1 and QOD for 41 days. | 15 |
| Total | 160 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 | FG012 | FG013 | FG014 | FG015 | FG016 | FG017 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Part 2: Cohort 4 | Part 2 Cohort 4: Placebo | Part 2: Cohort 3 | Part 2: Cohort 1 and 2 | Part 2 Cohorts 1-3: Placebo | Part 1 MAD: Cohort 3 | Part 1 MAD: Cohort 2 | Part 1 Cohorts 1-8 SAD: Placebo | Part 1 MAD: Cohort 1 | Part 1 Cohorts 1-3, MAD: Placebo | Part 1 SAD: Cohort 8 | Part 1 SAD: Cohort 7 | Part 1 SAD: Cohort 6 | Part 1 SAD: Cohort 5 | Part 1 SAD: Cohort 4 | Part 1 SAD: Cohort 3 | Part 1 SAD: Cohort 2 | Part 1 SAD: Cohort 1 | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 40.1 years STANDARD_DEVIATION 9.3 | 42.6 years STANDARD_DEVIATION 11.5 | 42.4 years STANDARD_DEVIATION 10.5 | 47.6 years STANDARD_DEVIATION 8.9 | 49.3 years STANDARD_DEVIATION 13.3 | 25.0 years STANDARD_DEVIATION 7.5 | 26.5 years STANDARD_DEVIATION 2.9 | 28.7 years STANDARD_DEVIATION 10.1 | 26.8 years STANDARD_DEVIATION 3.9 | 27.2 years STANDARD_DEVIATION 4 | 29.5 years STANDARD_DEVIATION 10.9 | 25.8 years STANDARD_DEVIATION 3.5 | 33.4 years STANDARD_DEVIATION 12.5 | 29.3 years STANDARD_DEVIATION 7 | 23.8 years STANDARD_DEVIATION 4.5 | 22.6 years STANDARD_DEVIATION 2.7 | 37.6 years STANDARD_DEVIATION 16.2 | 31.5 years STANDARD_DEVIATION 15.8 | 33.3 years STANDARD_DEVIATION 12.2 |
| Race/Ethnicity, Customized Asian | 6 Participants | 2 Participants | 5 Participants | 9 Participants | 1 Participants | 2 Participants | 3 Participants | 2 Participants | 0 Participants | 0 Participants | 4 Participants | 1 Participants | 3 Participants | 1 Participants | 2 Participants | 0 Participants | 1 Participants | 2 Participants | 44 Participants |
| Race/Ethnicity, Customized Black or African American | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 6 Participants |
| Race/Ethnicity, Customized Multiple | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 3 Participants |
| Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 7 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 14 Participants | 5 Participants | 8 Participants | 15 Participants | 6 Participants | 8 Participants | 8 Participants | 14 Participants | 8 Participants | 6 Participants | 8 Participants | 7 Participants | 7 Participants | 7 Participants | 8 Participants | 8 Participants | 7 Participants | 8 Participants | 152 Participants |
| Race/Ethnicity, Customized Not Stated | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Unknown | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 8 Participants | 3 Participants | 3 Participants | 5 Participants | 4 Participants | 4 Participants | 4 Participants | 13 Participants | 7 Participants | 6 Participants | 3 Participants | 7 Participants | 5 Participants | 7 Participants | 6 Participants | 8 Participants | 6 Participants | 4 Participants | 103 Participants |
| Sex: Female, Male Female | 9 Participants | 1 Participants | 2 Participants | 4 Participants | 1 Participants | 2 Participants | 4 Participants | 5 Participants | 2 Participants | 2 Participants | 2 Participants | 3 Participants | 1 Participants | 2 Participants | 2 Participants | 2 Participants | 2 Participants | 2 Participants | 48 Participants |
| Sex: Female, Male Male | 6 Participants | 4 Participants | 6 Participants | 12 Participants | 5 Participants | 6 Participants | 4 Participants | 11 Participants | 6 Participants | 4 Participants | 6 Participants | 5 Participants | 7 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 112 Participants |
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 | EG014 affected / at risk | EG015 affected / at risk | EG016 affected / at risk | EG017 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 6 | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 6 | 0 / 16 | 0 / 8 | 0 / 5 | 0 / 15 |
| other Total, other adverse events | 5 / 16 | 2 / 8 | 4 / 8 | 2 / 8 | 2 / 8 | 2 / 8 | 2 / 8 | 2 / 8 | 3 / 8 | 5 / 6 | 6 / 8 | 7 / 8 | 7 / 8 | 3 / 6 | 11 / 16 | 6 / 8 | 3 / 5 | 12 / 15 |
| serious Total, serious adverse events | 0 / 16 | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 6 | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 6 | 0 / 16 | 0 / 8 | 0 / 5 | 1 / 15 |
Outcome results
Primary
Part 1: Percentage of MAD Participants With Abnormalities in ECG Parameters
Triplicate 12-lead ECGs were obtained after the participants has been in a supine position for at least 10 minutes. Clinically significant RO7020531-related changes included confirmation of mean QTc 500 msec or 60 msec longer than the pre-dose baseline.
Time frame: From randomization up to Day 20
Population: Safety analysis population included all HVs who had received at least 1 dose of study drug. Number analyzed is the number of participants with data available for analysis at the specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Percentage of MAD Participants With Abnormalities in ECG Parameters | Average PR (12-Lead Trip.) - Low | 0 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Percentage of MAD Participants With Abnormalities in ECG Parameters | Average PR (12-Lead Trip.) - High | 0 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 1: Percentage of MAD Participants With Abnormalities in ECG Parameters | Average PR (12-Lead Trip.) - High | 14.3 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 1: Percentage of MAD Participants With Abnormalities in ECG Parameters | Average PR (12-Lead Trip.) - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 1: Percentage of MAD Participants With Abnormalities in ECG Parameters | Average PR (12-Lead Trip.) - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 1: Percentage of MAD Participants With Abnormalities in ECG Parameters | Average PR (12-Lead Trip.) - High | 14.3 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 1: Percentage of MAD Participants With Abnormalities in ECG Parameters | Average PR (12-Lead Trip.) - Low | 12.5 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 1: Percentage of MAD Participants With Abnormalities in ECG Parameters | Average PR (12-Lead Trip.) - High | 0 percentage of participants |
Primary
Part 1: Percentage of MAD Participants With Abnormalities in Vital Signs
Vital signs include blood pressure, pulse rate, respiratory rate and body temperature. Blood pressure, respiratory rate and pulse rate were obtained after the participant had been in a supine or sitting position for at least 5 minutes. Blood pressure measurement were performed in triplicate (can be as short as 20 second to 1 minute interval between measurements).
Time frame: From randomization up to Day 20
Population: Safety analysis population included all HVs who had received at least 1 dose of study drug. Number analyzed is the number of participants with data available for analysis at the specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Percentage of MAD Participants With Abnormalities in Vital Signs | Average Diastolic BP - High | 0 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Percentage of MAD Participants With Abnormalities in Vital Signs | Average Systolic BP - High | 0 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Percentage of MAD Participants With Abnormalities in Vital Signs | Pulse Rate - High | 0 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Percentage of MAD Participants With Abnormalities in Vital Signs | Respiratory Rate - High | 33.3 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Percentage of MAD Participants With Abnormalities in Vital Signs | Temperature - Low | 100.0 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Percentage of MAD Participants With Abnormalities in Vital Signs | Temperature - High | 0 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 1: Percentage of MAD Participants With Abnormalities in Vital Signs | Temperature - High | 0 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 1: Percentage of MAD Participants With Abnormalities in Vital Signs | Respiratory Rate - High | 25.0 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 1: Percentage of MAD Participants With Abnormalities in Vital Signs | Average Diastolic BP - High | 0 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 1: Percentage of MAD Participants With Abnormalities in Vital Signs | Pulse Rate - High | 0 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 1: Percentage of MAD Participants With Abnormalities in Vital Signs | Average Systolic BP - High | 25.0 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 1: Percentage of MAD Participants With Abnormalities in Vital Signs | Temperature - Low | 100.0 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 1: Percentage of MAD Participants With Abnormalities in Vital Signs | Average Systolic BP - High | 12.5 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 1: Percentage of MAD Participants With Abnormalities in Vital Signs | Pulse Rate - High | 0 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 1: Percentage of MAD Participants With Abnormalities in Vital Signs | Respiratory Rate - High | 37.5 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 1: Percentage of MAD Participants With Abnormalities in Vital Signs | Temperature - High | 25.0 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 1: Percentage of MAD Participants With Abnormalities in Vital Signs | Temperature - Low | 75.0 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 1: Percentage of MAD Participants With Abnormalities in Vital Signs | Average Diastolic BP - High | 0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 1: Percentage of MAD Participants With Abnormalities in Vital Signs | Temperature - High | 37.5 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 1: Percentage of MAD Participants With Abnormalities in Vital Signs | Average Systolic BP - High | 12.5 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 1: Percentage of MAD Participants With Abnormalities in Vital Signs | Average Diastolic BP - High | 12.5 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 1: Percentage of MAD Participants With Abnormalities in Vital Signs | Respiratory Rate - High | 50.0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 1: Percentage of MAD Participants With Abnormalities in Vital Signs | Temperature - Low | 50.0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 1: Percentage of MAD Participants With Abnormalities in Vital Signs | Pulse Rate - High | 12.5 percentage of participants |
Primary
Part 1: Percentage of MAD Participants With AEs
An AE is any untoward medical occurrence in a clinical investigation healthy volunteer (HV)/participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product, any new disease or exacerbation of an existing disease (a worsening in the character, frequency, or severity of a known condition and recurrence of an intermittent medical condition (e.g., headache) not present at baseline.
Time frame: From randomization up to Day 41
Population: Safety analysis population included all HVs who had received at least 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Percentage of MAD Participants With AEs | 83.3 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 1: Percentage of MAD Participants With AEs | 75.0 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 1: Percentage of MAD Participants With AEs | 87.5 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 1: Percentage of MAD Participants With AEs | 87.5 percentage of participants |
Primary
Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
For all laboratory parameters included, there exists a Roche predefined standard reference range. Laboratory values falling outside this standard reference range were labeled H for high or L for low in HV/participant listings of laboratory data.
Time frame: From randomization up to Day 20
Population: Safety analysis population included all HVs who had received at least 1 dose of study drug. Number analyzed is the number of participants with data available for analysis at the specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Uric Acid - Low | 0 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | SGPT/ALT - High | 0 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Creatinine - Low | 0 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Hematocrit - Low | 16.7 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | SGOT/AST - High | 0 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Protein, Total - Low | 25.0 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Cystatin C - High | 0 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Alkaline Phosphatase - Low | 0 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Phosphorus - High | 0 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Direct Bilirubin - High | 20.0 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Red blood cell count - Low | 0 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Erythrocyte Mean Corpuscular Hemoglobin - Low | 0 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Erythrocyte Mean Corpuscular HGB Concentration - High | 0 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Bicarbonate CO2 - Low | 16.7 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Albumin - Low | 40.0 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Erythrocyte Mean Corpuscular HGB Concentration - Low | 0 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Eosinophils Absolute - High | 0 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Blood Glucose, Fasting - High | 20.0 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Neutrophils, Total, Absolute | 16.7 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | White Blood Cell Count - Low | 0 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Creatinine Clearance - High | 66.7 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Blood Urea Nitrogen - Low | 33.3 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Reticulocytes, Pct - High | 0 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Creatinine Clearance - Low | 16.7 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Uric Acid - High | 16.7 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Cholesterol - High | 16.7 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Hemoglobin - Low | 16.7 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | SGPT/ALT - High | 12.5 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | White Blood Cell Count - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Albumin - Low | 37.5 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Alkaline Phosphatase - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Bicarbonate CO2 - Low | 12.5 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Blood Glucose, Fasting - High | 12.5 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Blood Urea Nitrogen - Low | 33.3 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Cholesterol - High | 12.5 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Creatinine - Low | 25.0 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Cystatin C - High | 33.3 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Direct Bilirubin - High | 14.3 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Phosphorus - High | 12.5 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Protein, Total - Low | 75.0 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | SGOT/AST - High | 12.5 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Uric Acid - Low | 12.5 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Uric Acid - High | 12.5 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Creatinine Clearance - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Creatinine Clearance - High | 33.3 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Eosinophils Absolute - High | 12.5 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Erythrocyte Mean Corpuscular HGB Concentration - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Erythrocyte Mean Corpuscular HGB Concentration - High | 14.3 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Erythrocyte Mean Corpuscular Hemoglobin - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Hematocrit - Low | 62.5 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Hemoglobin - Low | 50.0 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Neutrophils, Total, Absolute | 25.0 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Red blood cell count - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Reticulocytes, Pct - High | 0 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Cholesterol - High | 20.0 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | SGPT/ALT - High | 0 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Uric Acid - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Uric Acid - High | 0 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Blood Urea Nitrogen - Low | 80.0 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Creatinine Clearance - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Neutrophils, Total, Absolute | 16.7 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Creatinine Clearance - High | 20.0 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Blood Glucose, Fasting - High | 16.7 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Eosinophils Absolute - High | 0 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Bicarbonate CO2 - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Erythrocyte Mean Corpuscular HGB Concentration - Low | 28.6 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Reticulocytes, Pct - High | 25.0 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Erythrocyte Mean Corpuscular HGB Concentration - High | 0 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Alkaline Phosphatase - Low | 12.5 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Red blood cell count - Low | 25.0 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Erythrocyte Mean Corpuscular Hemoglobin - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Hematocrit - Low | 62.5 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Direct Bilirubin - High | 0 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Cystatin C - High | 0 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Albumin - Low | 37.5 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Phosphorus - High | 12.5 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | White Blood Cell Count - Low | 20.0 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Protein, Total - Low | 50.0 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Creatinine - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Hemoglobin - Low | 62.5 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | SGOT/AST - High | 0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Creatinine - Low | 42.9 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Direct Bilirubin - High | 14.3 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | SGPT/ALT - High | 14.3 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Hemoglobin - Low | 37.5 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Erythrocyte Mean Corpuscular HGB Concentration - High | 0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Uric Acid - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Blood Urea Nitrogen - Low | 100.0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Creatinine Clearance - High | 33.3 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Cholesterol - High | 14.3 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Uric Acid - High | 0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | SGOT/AST - High | 0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Reticulocytes, Pct - High | 12.5 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Protein, Total - Low | 62.5 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Creatinine Clearance - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Blood Glucose, Fasting - High | 14.3 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Erythrocyte Mean Corpuscular Hemoglobin - Low | 12.5 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Albumin - Low | 25.0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Red blood cell count - Low | 25.0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Bicarbonate CO2 - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Neutrophils, Total, Absolute | 37.5 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Phosphorus - High | 25.0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Eosinophils Absolute - High | 0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Cystatin C - High | 0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | White Blood Cell Count - Low | 25.0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Hematocrit - Low | 37.5 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Erythrocyte Mean Corpuscular HGB Concentration - Low | 42.9 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Alkaline Phosphatase - Low | 0 percentage of participants |
Primary
Part 1: Percentage of SAD Participants With Abnormalities in Electrocardiograph (ECG) Parameters
Triplicate 12-lead ECGs were obtained after the participant has been in a supine position for at least 10 minutes. Clinically significant RO7020531-related changes included confirmation of mean QTc 500 milliseconds (msec) or 60 msec longer than the pre-dose baseline.
Time frame: From randomization up to Day 8
Population: Safety analysis population included all HVs who had received at least 1 dose of study drug. Number analyzed is the number of participants with data available for analysis at the specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Percentage of SAD Participants With Abnormalities in Electrocardiograph (ECG) Parameters | Average PR (12-Lead Trip.) - Low | 0 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Percentage of SAD Participants With Abnormalities in Electrocardiograph (ECG) Parameters | Average QRS (12-Lead Trip.) - High | 0 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Percentage of SAD Participants With Abnormalities in Electrocardiograph (ECG) Parameters | Average PR (12-Lead Trip.) - High | 0 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Percentage of SAD Participants With Abnormalities in Electrocardiograph (ECG) Parameters | Average Heart Rate (12-Lead Trip.) - High | 0 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Percentage of SAD Participants With Abnormalities in Electrocardiograph (ECG) Parameters | Average Heart Rate (12-Lead Trip.) - Low | 6.3 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Percentage of SAD Participants With Abnormalities in Electrocardiograph (ECG) Parameters | Average QTcF (12-Lead Trip.) - High | 0 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 1: Percentage of SAD Participants With Abnormalities in Electrocardiograph (ECG) Parameters | Average QTcF (12-Lead Trip.) - High | 12.5 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 1: Percentage of SAD Participants With Abnormalities in Electrocardiograph (ECG) Parameters | Average PR (12-Lead Trip.) - High | 0 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 1: Percentage of SAD Participants With Abnormalities in Electrocardiograph (ECG) Parameters | Average PR (12-Lead Trip.) - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 1: Percentage of SAD Participants With Abnormalities in Electrocardiograph (ECG) Parameters | Average Heart Rate (12-Lead Trip.) - High | 0 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 1: Percentage of SAD Participants With Abnormalities in Electrocardiograph (ECG) Parameters | Average QRS (12-Lead Trip.) - High | 0 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 1: Percentage of SAD Participants With Abnormalities in Electrocardiograph (ECG) Parameters | Average Heart Rate (12-Lead Trip.) - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 1: Percentage of SAD Participants With Abnormalities in Electrocardiograph (ECG) Parameters | Average PR (12-Lead Trip.) - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 1: Percentage of SAD Participants With Abnormalities in Electrocardiograph (ECG) Parameters | Average QRS (12-Lead Trip.) - High | 0 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 1: Percentage of SAD Participants With Abnormalities in Electrocardiograph (ECG) Parameters | Average PR (12-Lead Trip.) - High | 0 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 1: Percentage of SAD Participants With Abnormalities in Electrocardiograph (ECG) Parameters | Average QTcF (12-Lead Trip.) - High | 0 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 1: Percentage of SAD Participants With Abnormalities in Electrocardiograph (ECG) Parameters | Average Heart Rate (12-Lead Trip.) - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 1: Percentage of SAD Participants With Abnormalities in Electrocardiograph (ECG) Parameters | Average Heart Rate (12-Lead Trip.) - High | 12.5 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 1: Percentage of SAD Participants With Abnormalities in Electrocardiograph (ECG) Parameters | Average PR (12-Lead Trip.) - High | 12.5 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 1: Percentage of SAD Participants With Abnormalities in Electrocardiograph (ECG) Parameters | Average QRS (12-Lead Trip.) - High | 0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 1: Percentage of SAD Participants With Abnormalities in Electrocardiograph (ECG) Parameters | Average Heart Rate (12-Lead Trip.) - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 1: Percentage of SAD Participants With Abnormalities in Electrocardiograph (ECG) Parameters | Average Heart Rate (12-Lead Trip.) - High | 0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 1: Percentage of SAD Participants With Abnormalities in Electrocardiograph (ECG) Parameters | Average PR (12-Lead Trip.) - Low | 12.5 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 1: Percentage of SAD Participants With Abnormalities in Electrocardiograph (ECG) Parameters | Average QTcF (12-Lead Trip.) - High | 0 percentage of participants |
| Part 1 SAD: Cohort 4 | Part 1: Percentage of SAD Participants With Abnormalities in Electrocardiograph (ECG) Parameters | Average PR (12-Lead Trip.) - High | 0 percentage of participants |
| Part 1 SAD: Cohort 4 | Part 1: Percentage of SAD Participants With Abnormalities in Electrocardiograph (ECG) Parameters | Average Heart Rate (12-Lead Trip.) - High | 0 percentage of participants |
| Part 1 SAD: Cohort 4 | Part 1: Percentage of SAD Participants With Abnormalities in Electrocardiograph (ECG) Parameters | Average PR (12-Lead Trip.) - Low | 14.3 percentage of participants |
| Part 1 SAD: Cohort 4 | Part 1: Percentage of SAD Participants With Abnormalities in Electrocardiograph (ECG) Parameters | Average Heart Rate (12-Lead Trip.) - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 4 | Part 1: Percentage of SAD Participants With Abnormalities in Electrocardiograph (ECG) Parameters | Average QRS (12-Lead Trip.) - High | 0 percentage of participants |
| Part 1 SAD: Cohort 4 | Part 1: Percentage of SAD Participants With Abnormalities in Electrocardiograph (ECG) Parameters | Average QTcF (12-Lead Trip.) - High | 0 percentage of participants |
| Part 1 SAD: Cohort 5 | Part 1: Percentage of SAD Participants With Abnormalities in Electrocardiograph (ECG) Parameters | Average QRS (12-Lead Trip.) - High | 12.5 percentage of participants |
| Part 1 SAD: Cohort 5 | Part 1: Percentage of SAD Participants With Abnormalities in Electrocardiograph (ECG) Parameters | Average Heart Rate (12-Lead Trip.) - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 5 | Part 1: Percentage of SAD Participants With Abnormalities in Electrocardiograph (ECG) Parameters | Average PR (12-Lead Trip.) - High | 0 percentage of participants |
| Part 1 SAD: Cohort 5 | Part 1: Percentage of SAD Participants With Abnormalities in Electrocardiograph (ECG) Parameters | Average QTcF (12-Lead Trip.) - High | 0 percentage of participants |
| Part 1 SAD: Cohort 5 | Part 1: Percentage of SAD Participants With Abnormalities in Electrocardiograph (ECG) Parameters | Average Heart Rate (12-Lead Trip.) - High | 0 percentage of participants |
| Part 1 SAD: Cohort 5 | Part 1: Percentage of SAD Participants With Abnormalities in Electrocardiograph (ECG) Parameters | Average PR (12-Lead Trip.) - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 6 | Part 1: Percentage of SAD Participants With Abnormalities in Electrocardiograph (ECG) Parameters | Average PR (12-Lead Trip.) - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 6 | Part 1: Percentage of SAD Participants With Abnormalities in Electrocardiograph (ECG) Parameters | Average QRS (12-Lead Trip.) - High | 0 percentage of participants |
| Part 1 SAD: Cohort 6 | Part 1: Percentage of SAD Participants With Abnormalities in Electrocardiograph (ECG) Parameters | Average Heart Rate (12-Lead Trip.) - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 6 | Part 1: Percentage of SAD Participants With Abnormalities in Electrocardiograph (ECG) Parameters | Average QTcF (12-Lead Trip.) - High | 0 percentage of participants |
| Part 1 SAD: Cohort 6 | Part 1: Percentage of SAD Participants With Abnormalities in Electrocardiograph (ECG) Parameters | Average PR (12-Lead Trip.) - High | 0 percentage of participants |
| Part 1 SAD: Cohort 6 | Part 1: Percentage of SAD Participants With Abnormalities in Electrocardiograph (ECG) Parameters | Average Heart Rate (12-Lead Trip.) - High | 0 percentage of participants |
| Part 1 SAD: Cohort 7 | Part 1: Percentage of SAD Participants With Abnormalities in Electrocardiograph (ECG) Parameters | Average QRS (12-Lead Trip.) - High | 12.5 percentage of participants |
| Part 1 SAD: Cohort 7 | Part 1: Percentage of SAD Participants With Abnormalities in Electrocardiograph (ECG) Parameters | Average Heart Rate (12-Lead Trip.) - High | 0 percentage of participants |
| Part 1 SAD: Cohort 7 | Part 1: Percentage of SAD Participants With Abnormalities in Electrocardiograph (ECG) Parameters | Average Heart Rate (12-Lead Trip.) - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 7 | Part 1: Percentage of SAD Participants With Abnormalities in Electrocardiograph (ECG) Parameters | Average QTcF (12-Lead Trip.) - High | 0 percentage of participants |
| Part 1 SAD: Cohort 7 | Part 1: Percentage of SAD Participants With Abnormalities in Electrocardiograph (ECG) Parameters | Average PR (12-Lead Trip.) - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 7 | Part 1: Percentage of SAD Participants With Abnormalities in Electrocardiograph (ECG) Parameters | Average PR (12-Lead Trip.) - High | 12.5 percentage of participants |
| Part 1 SAD: Cohort 8 | Part 1: Percentage of SAD Participants With Abnormalities in Electrocardiograph (ECG) Parameters | Average QRS (12-Lead Trip.) - High | 0 percentage of participants |
| Part 1 SAD: Cohort 8 | Part 1: Percentage of SAD Participants With Abnormalities in Electrocardiograph (ECG) Parameters | Average PR (12-Lead Trip.) - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 8 | Part 1: Percentage of SAD Participants With Abnormalities in Electrocardiograph (ECG) Parameters | Average Heart Rate (12-Lead Trip.) - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 8 | Part 1: Percentage of SAD Participants With Abnormalities in Electrocardiograph (ECG) Parameters | Average Heart Rate (12-Lead Trip.) - High | 0 percentage of participants |
| Part 1 SAD: Cohort 8 | Part 1: Percentage of SAD Participants With Abnormalities in Electrocardiograph (ECG) Parameters | Average PR (12-Lead Trip.) - High | 0 percentage of participants |
| Part 1 SAD: Cohort 8 | Part 1: Percentage of SAD Participants With Abnormalities in Electrocardiograph (ECG) Parameters | Average QTcF (12-Lead Trip.) - High | 0 percentage of participants |
Primary
Part 1: Percentage of SAD Participants With Abnormalities in Vital Signs
Vital signs include blood pressure, pulse rate, respiratory rate and body temperature. Blood pressure, respiratory rate and pulse rate were obtained after the participant had been in a supine or sitting position for at least 5 minutes. Blood pressure measurement were performed in triplicate (can be as short as 20 second to 1 minute interval between measurements).
Time frame: From randomization up to Day 8
Population: Safety analysis population included all HVs who had received at least 1 dose of study drug. Number analyzed is the number of participants with data available for analysis at the specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Percentage of SAD Participants With Abnormalities in Vital Signs | Pulse Rate - Low | 6.3 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Percentage of SAD Participants With Abnormalities in Vital Signs | Average Systolic BP - High | 6.3 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Percentage of SAD Participants With Abnormalities in Vital Signs | Pulse Rate - High | 0 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Percentage of SAD Participants With Abnormalities in Vital Signs | Temperature - High | 12.5 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Percentage of SAD Participants With Abnormalities in Vital Signs | Temperature - Low | 71.4 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Percentage of SAD Participants With Abnormalities in Vital Signs | Respiratory Rate - High | 26.7 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Percentage of SAD Participants With Abnormalities in Vital Signs | Average Diastolic BP - High | 0 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 1: Percentage of SAD Participants With Abnormalities in Vital Signs | Pulse Rate - High | 0 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 1: Percentage of SAD Participants With Abnormalities in Vital Signs | Average Systolic BP - High | 0 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 1: Percentage of SAD Participants With Abnormalities in Vital Signs | Respiratory Rate - High | 0 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 1: Percentage of SAD Participants With Abnormalities in Vital Signs | Pulse Rate - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 1: Percentage of SAD Participants With Abnormalities in Vital Signs | Temperature - High | 0 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 1: Percentage of SAD Participants With Abnormalities in Vital Signs | Average Diastolic BP - High | 12.5 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 1: Percentage of SAD Participants With Abnormalities in Vital Signs | Temperature - Low | 100.0 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 1: Percentage of SAD Participants With Abnormalities in Vital Signs | Temperature - Low | 100.0 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 1: Percentage of SAD Participants With Abnormalities in Vital Signs | Pulse Rate - High | 12.5 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 1: Percentage of SAD Participants With Abnormalities in Vital Signs | Average Diastolic BP - High | 25.0 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 1: Percentage of SAD Participants With Abnormalities in Vital Signs | Average Systolic BP - High | 0 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 1: Percentage of SAD Participants With Abnormalities in Vital Signs | Pulse Rate - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 1: Percentage of SAD Participants With Abnormalities in Vital Signs | Respiratory Rate - High | 28.6 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 1: Percentage of SAD Participants With Abnormalities in Vital Signs | Temperature - High | 12.5 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 1: Percentage of SAD Participants With Abnormalities in Vital Signs | Temperature - High | 0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 1: Percentage of SAD Participants With Abnormalities in Vital Signs | Average Diastolic BP - High | 0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 1: Percentage of SAD Participants With Abnormalities in Vital Signs | Pulse Rate - High | 0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 1: Percentage of SAD Participants With Abnormalities in Vital Signs | Respiratory Rate - High | 0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 1: Percentage of SAD Participants With Abnormalities in Vital Signs | Pulse Rate - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 1: Percentage of SAD Participants With Abnormalities in Vital Signs | Average Systolic BP - High | 12.5 percentage of participants |
| Part 1 SAD: Cohort 4 | Part 1: Percentage of SAD Participants With Abnormalities in Vital Signs | Average Systolic BP - High | 12.5 percentage of participants |
| Part 1 SAD: Cohort 4 | Part 1: Percentage of SAD Participants With Abnormalities in Vital Signs | Pulse Rate - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 4 | Part 1: Percentage of SAD Participants With Abnormalities in Vital Signs | Temperature - Low | 100.0 percentage of participants |
| Part 1 SAD: Cohort 4 | Part 1: Percentage of SAD Participants With Abnormalities in Vital Signs | Respiratory Rate - High | 0 percentage of participants |
| Part 1 SAD: Cohort 4 | Part 1: Percentage of SAD Participants With Abnormalities in Vital Signs | Average Diastolic BP - High | 0 percentage of participants |
| Part 1 SAD: Cohort 4 | Part 1: Percentage of SAD Participants With Abnormalities in Vital Signs | Temperature - High | 0 percentage of participants |
| Part 1 SAD: Cohort 4 | Part 1: Percentage of SAD Participants With Abnormalities in Vital Signs | Pulse Rate - High | 0 percentage of participants |
| Part 1 SAD: Cohort 5 | Part 1: Percentage of SAD Participants With Abnormalities in Vital Signs | Average Diastolic BP - High | 0 percentage of participants |
| Part 1 SAD: Cohort 5 | Part 1: Percentage of SAD Participants With Abnormalities in Vital Signs | Temperature - High | 0 percentage of participants |
| Part 1 SAD: Cohort 5 | Part 1: Percentage of SAD Participants With Abnormalities in Vital Signs | Average Systolic BP - High | 12.5 percentage of participants |
| Part 1 SAD: Cohort 5 | Part 1: Percentage of SAD Participants With Abnormalities in Vital Signs | Pulse Rate - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 5 | Part 1: Percentage of SAD Participants With Abnormalities in Vital Signs | Respiratory Rate - High | 0 percentage of participants |
| Part 1 SAD: Cohort 5 | Part 1: Percentage of SAD Participants With Abnormalities in Vital Signs | Pulse Rate - High | 0 percentage of participants |
| Part 1 SAD: Cohort 5 | Part 1: Percentage of SAD Participants With Abnormalities in Vital Signs | Temperature - Low | 100.0 percentage of participants |
| Part 1 SAD: Cohort 6 | Part 1: Percentage of SAD Participants With Abnormalities in Vital Signs | Pulse Rate - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 6 | Part 1: Percentage of SAD Participants With Abnormalities in Vital Signs | Average Systolic BP - High | 0 percentage of participants |
| Part 1 SAD: Cohort 6 | Part 1: Percentage of SAD Participants With Abnormalities in Vital Signs | Respiratory Rate - High | 12.5 percentage of participants |
| Part 1 SAD: Cohort 6 | Part 1: Percentage of SAD Participants With Abnormalities in Vital Signs | Average Diastolic BP - High | 0 percentage of participants |
| Part 1 SAD: Cohort 6 | Part 1: Percentage of SAD Participants With Abnormalities in Vital Signs | Pulse Rate - High | 0 percentage of participants |
| Part 1 SAD: Cohort 6 | Part 1: Percentage of SAD Participants With Abnormalities in Vital Signs | Temperature - High | 0 percentage of participants |
| Part 1 SAD: Cohort 6 | Part 1: Percentage of SAD Participants With Abnormalities in Vital Signs | Temperature - Low | 100.0 percentage of participants |
| Part 1 SAD: Cohort 7 | Part 1: Percentage of SAD Participants With Abnormalities in Vital Signs | Pulse Rate - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 7 | Part 1: Percentage of SAD Participants With Abnormalities in Vital Signs | Respiratory Rate - High | 25.0 percentage of participants |
| Part 1 SAD: Cohort 7 | Part 1: Percentage of SAD Participants With Abnormalities in Vital Signs | Temperature - Low | 80.0 percentage of participants |
| Part 1 SAD: Cohort 7 | Part 1: Percentage of SAD Participants With Abnormalities in Vital Signs | Average Systolic BP - High | 0 percentage of participants |
| Part 1 SAD: Cohort 7 | Part 1: Percentage of SAD Participants With Abnormalities in Vital Signs | Temperature - High | 25.0 percentage of participants |
| Part 1 SAD: Cohort 7 | Part 1: Percentage of SAD Participants With Abnormalities in Vital Signs | Pulse Rate - High | 0 percentage of participants |
| Part 1 SAD: Cohort 7 | Part 1: Percentage of SAD Participants With Abnormalities in Vital Signs | Average Diastolic BP - High | 0 percentage of participants |
| Part 1 SAD: Cohort 8 | Part 1: Percentage of SAD Participants With Abnormalities in Vital Signs | Temperature - High | 0 percentage of participants |
| Part 1 SAD: Cohort 8 | Part 1: Percentage of SAD Participants With Abnormalities in Vital Signs | Average Systolic BP - High | 0 percentage of participants |
| Part 1 SAD: Cohort 8 | Part 1: Percentage of SAD Participants With Abnormalities in Vital Signs | Pulse Rate - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 8 | Part 1: Percentage of SAD Participants With Abnormalities in Vital Signs | Respiratory Rate - High | 0 percentage of participants |
| Part 1 SAD: Cohort 8 | Part 1: Percentage of SAD Participants With Abnormalities in Vital Signs | Temperature - Low | 40.0 percentage of participants |
| Part 1 SAD: Cohort 8 | Part 1: Percentage of SAD Participants With Abnormalities in Vital Signs | Average Diastolic BP - High | 0 percentage of participants |
| Part 1 SAD: Cohort 8 | Part 1: Percentage of SAD Participants With Abnormalities in Vital Signs | Pulse Rate - High | 0 percentage of participants |
Primary
Part 1: Percentage of SAD Participants With Adverse Events (AEs)
An AE is any untoward medical occurrence in a clinical investigation healthy volunteer (HV)/participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product, any new disease or exacerbation of an existing disease (a worsening in the character, frequency, or severity of a known condition and recurrence of an intermittent medical condition (e.g., headache) not present at baseline.
Time frame: From randomization up to Day 29
Population: Safety analysis population included all HVs who had received at least 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Percentage of SAD Participants With Adverse Events (AEs) | 31.3 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 1: Percentage of SAD Participants With Adverse Events (AEs) | 25.0 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 1: Percentage of SAD Participants With Adverse Events (AEs) | 50.0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 1: Percentage of SAD Participants With Adverse Events (AEs) | 25.0 percentage of participants |
| Part 1 SAD: Cohort 4 | Part 1: Percentage of SAD Participants With Adverse Events (AEs) | 25.0 percentage of participants |
| Part 1 SAD: Cohort 5 | Part 1: Percentage of SAD Participants With Adverse Events (AEs) | 25.0 percentage of participants |
| Part 1 SAD: Cohort 6 | Part 1: Percentage of SAD Participants With Adverse Events (AEs) | 25.0 percentage of participants |
| Part 1 SAD: Cohort 7 | Part 1: Percentage of SAD Participants With Adverse Events (AEs) | 25.0 percentage of participants |
| Part 1 SAD: Cohort 8 | Part 1: Percentage of SAD Participants With Adverse Events (AEs) | 37.5 percentage of participants |
Primary
Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
For all laboratory parameters included, there exists a Roche predefined standard reference range. Laboratory values falling outside this standard reference range were labeled H for high or L for low in HV/participant listings of laboratory data.
Time frame: From randomization up to Day 8
Population: Safety population included all HVs who had received at least 1 dose of study drug. Number analyzed is the number of participants with data available for analysis at the specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Calcium - High | 6.3 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Eosinophils Absolute - High | 0 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | White Blood Cell Count - High | 0 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | White Blood Cell Count - Low | 13.3 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Chloride - Low | 6.3 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Reticulocytes, Pct - High | 0 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Cystatin C - High | 13.3 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Erythrocyte Mean Corpuscular HGB Concentration - Low | 0 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Creatinine Clearance - High | 23.1 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Creatinine Clearance - Low | 0 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Erythrocyte Mean Corpuscular Hemoglobin - Low | 6.7 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Potassium - Low | 0 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Uric Acid - High | 7.1 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Triglycerides, Fasting - High | 0 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Erythrocyte Mean Corpuscular Volume - High | 0 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Hematocrit - Low | 6.7 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Cystatin C - Low | 0 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Creatinine - High | 0 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Hemoglobin - Low | 6.3 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Sodium - High | 6.3 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Hemoglobin - High | 0 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Phosphorus - High | 6.3 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Creatinine - Low | 0 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Cholesterol - High | 8.3 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Lymphocytes Absolute - Low | 0 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | SGPT/ALT - High | 0 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Monocytes Absolute - High | 0 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | SGOT/AST - High | 0 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Protein, Total - High | 0 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Neutrophils, Total, Absolute - Low | 7.1 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Protein, Total - Low | 20.0 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Neutrophils, Total, Absolute - High | 0 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Red Blood Cell Count - Low | 6.3 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Red Blood Cell Count - High | 6.7 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Blood Glucose, Fasting - High | 7.1 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Platelet - High | 0 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Platelet - Low | 0 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Bicarbonate CO2 - Low | 6.3 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Blood Urea Nitrogen - Low | 7.1 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Direct Bilirubin - High | 14.3 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Alkaline Phosphatase - High | 0 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Blood Urea Nitrogen - High | 6.3 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Alkaline Phosphatase - Low | 0 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Albumin - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Blood Urea Nitrogen - High | 0 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Calcium - High | 0 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Hemoglobin - Low | 25.0 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Cholesterol - High | 20.0 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | White Blood Cell Count - High | 0 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Protein, Total - Low | 14.3 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Cystatin C - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | White Blood Cell Count - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Hematocrit - Low | 25.0 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Bicarbonate CO2 - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Chloride - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Lymphocytes Absolute - Low | 12.5 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Eosinophils Absolute - High | 0 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Phosphorus - High | 0 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Reticulocytes, Pct - High | 0 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | SGPT/ALT - High | 0 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Red Blood Cell Count - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Cystatin C - High | 12.5 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Alkaline Phosphatase - High | 0 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Sodium - High | 0 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Creatinine Clearance - High | 0 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Neutrophils, Total, Absolute - High | 0 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Erythrocyte Mean Corpuscular HGB Concentration - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Creatinine - High | 0 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Potassium - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Alkaline Phosphatase - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Monocytes Absolute - High | 12.5 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Creatinine Clearance - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Direct Bilirubin - High | 0 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Creatinine - Low | 12.5 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Albumin - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Erythrocyte Mean Corpuscular Hemoglobin - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | SGOT/AST - High | 0 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Blood Urea Nitrogen - Low | 12.5 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Uric Acid - High | 0 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Red Blood Cell Count - High | 0 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Hemoglobin - High | 0 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Triglycerides, Fasting - High | 0 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Protein, Total - High | 0 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Blood Glucose, Fasting - High | 12.5 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Erythrocyte Mean Corpuscular Volume - High | 0 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Platelet - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Neutrophils, Total, Absolute - Low | 14.3 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Platelet - High | 0 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Cystatin C - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Hematocrit - Low | 12.5 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Platelet - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Creatinine - High | 12.5 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Hemoglobin - Low | 12.5 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Sodium - High | 0 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Potassium - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Blood Glucose, Fasting - High | 50.0 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Creatinine - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Hemoglobin - High | 0 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Cholesterol - High | 0 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Bicarbonate CO2 - Low | 12.5 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | SGPT/ALT - High | 12.5 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Lymphocytes Absolute - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Blood Urea Nitrogen - High | 12.5 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | SGOT/AST - High | 12.5 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Cystatin C - High | 0 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Monocytes Absolute - High | 12.5 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Direct Bilirubin - High | 0 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Protein, Total - High | 0 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Blood Urea Nitrogen - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | White Blood Cell Count - High | 0 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Neutrophils, Total, Absolute - Low | 12.5 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Calcium - High | 0 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Protein, Total - Low | 25.0 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | White Blood Cell Count - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Alkaline Phosphatase - High | 0 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Red Blood Cell Count - Low | 12.5 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Chloride - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Reticulocytes, Pct - High | 12.5 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Eosinophils Absolute - High | 0 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Creatinine Clearance - High | 16.7 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Erythrocyte Mean Corpuscular HGB Concentration - Low | 12.5 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Neutrophils, Total, Absolute - High | 0 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Creatinine Clearance - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Uric Acid - High | 0 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Albumin - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Erythrocyte Mean Corpuscular Hemoglobin - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Alkaline Phosphatase - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Triglycerides, Fasting - High | 14.3 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Red Blood Cell Count - High | 0 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Platelet - High | 0 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Erythrocyte Mean Corpuscular Volume - High | 12.5 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Phosphorus - High | 0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Potassium - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Lymphocytes Absolute - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Erythrocyte Mean Corpuscular HGB Concentration - Low | 12.5 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Erythrocyte Mean Corpuscular Hemoglobin - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Erythrocyte Mean Corpuscular Volume - High | 0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Hematocrit - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Hemoglobin - Low | 12.5 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Hemoglobin - High | 0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Monocytes Absolute - High | 0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Neutrophils, Total, Absolute - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Neutrophils, Total, Absolute - High | 0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Blood Glucose, Fasting - High | 0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Blood Urea Nitrogen - Low | 14.3 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Blood Urea Nitrogen - High | 0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Calcium - High | 0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Chloride - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Red Blood Cell Count - High | 0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Reticulocytes, Pct - High | 0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | White Blood Cell Count - Low | 12.5 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | White Blood Cell Count - High | 0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Albumin - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Alkaline Phosphatase - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Alkaline Phosphatase - High | 12.5 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Bicarbonate CO2 - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Platelet - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Platelet - High | 0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Red Blood Cell Count - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Protein, Total - Low | 25.0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Protein, Total - High | 0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | SGOT/AST - High | 0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | SGPT/ALT - High | 0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Cholesterol - High | 0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Creatinine - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Sodium - High | 0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Creatinine - High | 0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Cystatin C - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Triglycerides, Fasting - High | 0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Uric Acid - High | 14.3 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Creatinine Clearance - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Creatinine Clearance - High | 20.0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Cystatin C - High | 0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Direct Bilirubin - High | 0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Phosphorus - High | 0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Eosinophils Absolute - High | 0 percentage of participants |
| Part 1 SAD: Cohort 4 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Calcium - High | 0 percentage of participants |
| Part 1 SAD: Cohort 4 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Platelet - Low | 12.5 percentage of participants |
| Part 1 SAD: Cohort 4 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Red Blood Cell Count - High | 0 percentage of participants |
| Part 1 SAD: Cohort 4 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Protein, Total - Low | 12.5 percentage of participants |
| Part 1 SAD: Cohort 4 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Neutrophils, Total, Absolute - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 4 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Potassium - Low | 12.5 percentage of participants |
| Part 1 SAD: Cohort 4 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Red Blood Cell Count - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 4 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Erythrocyte Mean Corpuscular Volume - High | 0 percentage of participants |
| Part 1 SAD: Cohort 4 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Platelet - High | 0 percentage of participants |
| Part 1 SAD: Cohort 4 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Creatinine Clearance - High | 20.0 percentage of participants |
| Part 1 SAD: Cohort 4 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Direct Bilirubin - High | 0 percentage of participants |
| Part 1 SAD: Cohort 4 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Neutrophils, Total, Absolute - High | 0 percentage of participants |
| Part 1 SAD: Cohort 4 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Erythrocyte Mean Corpuscular HGB Concentration - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 4 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Blood Urea Nitrogen - High | 0 percentage of participants |
| Part 1 SAD: Cohort 4 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Creatinine Clearance - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 4 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Uric Acid - High | 25.0 percentage of participants |
| Part 1 SAD: Cohort 4 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Erythrocyte Mean Corpuscular Hemoglobin - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 4 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Alkaline Phosphatase - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 4 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | White Blood Cell Count - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 4 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Triglycerides, Fasting - High | 28.6 percentage of participants |
| Part 1 SAD: Cohort 4 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Cystatin C - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 4 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Phosphorus - High | 12.5 percentage of participants |
| Part 1 SAD: Cohort 4 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Hematocrit - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 4 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Reticulocytes, Pct - High | 12.5 percentage of participants |
| Part 1 SAD: Cohort 4 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Blood Urea Nitrogen - Low | 14.3 percentage of participants |
| Part 1 SAD: Cohort 4 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Creatinine - High | 0 percentage of participants |
| Part 1 SAD: Cohort 4 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Alkaline Phosphatase - High | 0 percentage of participants |
| Part 1 SAD: Cohort 4 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Cystatin C - High | 12.5 percentage of participants |
| Part 1 SAD: Cohort 4 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Eosinophils Absolute - High | 0 percentage of participants |
| Part 1 SAD: Cohort 4 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Sodium - High | 0 percentage of participants |
| Part 1 SAD: Cohort 4 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Hemoglobin - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 4 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Creatinine - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 4 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Hemoglobin - High | 0 percentage of participants |
| Part 1 SAD: Cohort 4 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Cholesterol - High | 25.0 percentage of participants |
| Part 1 SAD: Cohort 4 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Lymphocytes Absolute - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 4 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Bicarbonate CO2 - Low | 12.5 percentage of participants |
| Part 1 SAD: Cohort 4 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | White Blood Cell Count - High | 0 percentage of participants |
| Part 1 SAD: Cohort 4 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Chloride - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 4 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | SGPT/ALT - High | 14.3 percentage of participants |
| Part 1 SAD: Cohort 4 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | SGOT/AST - High | 0 percentage of participants |
| Part 1 SAD: Cohort 4 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Monocytes Absolute - High | 0 percentage of participants |
| Part 1 SAD: Cohort 4 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Albumin - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 4 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Blood Glucose, Fasting - High | 0 percentage of participants |
| Part 1 SAD: Cohort 4 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Protein, Total - High | 0 percentage of participants |
| Part 1 SAD: Cohort 5 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Erythrocyte Mean Corpuscular Volume - High | 0 percentage of participants |
| Part 1 SAD: Cohort 5 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Blood Urea Nitrogen - High | 0 percentage of participants |
| Part 1 SAD: Cohort 5 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Albumin - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 5 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Alkaline Phosphatase - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 5 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Blood Urea Nitrogen - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 5 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Alkaline Phosphatase - High | 0 percentage of participants |
| Part 1 SAD: Cohort 5 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Bicarbonate CO2 - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 5 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Neutrophils, Total, Absolute - High | 0 percentage of participants |
| Part 1 SAD: Cohort 5 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Blood Glucose, Fasting - High | 0 percentage of participants |
| Part 1 SAD: Cohort 5 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Lymphocytes Absolute - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 5 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Platelet - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 5 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Platelet - High | 0 percentage of participants |
| Part 1 SAD: Cohort 5 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Red Blood Cell Count - Low | 12.5 percentage of participants |
| Part 1 SAD: Cohort 5 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Potassium - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 5 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Neutrophils, Total, Absolute - Low | 16.7 percentage of participants |
| Part 1 SAD: Cohort 5 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Direct Bilirubin - High | 0 percentage of participants |
| Part 1 SAD: Cohort 5 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Protein, Total - Low | 25.0 percentage of participants |
| Part 1 SAD: Cohort 5 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Protein, Total - High | 0 percentage of participants |
| Part 1 SAD: Cohort 5 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Monocytes Absolute - High | 0 percentage of participants |
| Part 1 SAD: Cohort 5 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | SGOT/AST - High | 12.5 percentage of participants |
| Part 1 SAD: Cohort 5 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | SGPT/ALT - High | 12.5 percentage of participants |
| Part 1 SAD: Cohort 5 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Hemoglobin - High | 0 percentage of participants |
| Part 1 SAD: Cohort 5 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Cholesterol - High | 0 percentage of participants |
| Part 1 SAD: Cohort 5 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Creatinine - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 5 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Hemoglobin - Low | 25.0 percentage of participants |
| Part 1 SAD: Cohort 5 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Sodium - High | 0 percentage of participants |
| Part 1 SAD: Cohort 5 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Creatinine - High | 0 percentage of participants |
| Part 1 SAD: Cohort 5 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Hematocrit - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 5 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Cystatin C - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 5 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Phosphorus - High | 0 percentage of participants |
| Part 1 SAD: Cohort 5 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Triglycerides, Fasting - High | 0 percentage of participants |
| Part 1 SAD: Cohort 5 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Erythrocyte Mean Corpuscular Hemoglobin - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 5 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Uric Acid - High | 0 percentage of participants |
| Part 1 SAD: Cohort 5 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Erythrocyte Mean Corpuscular HGB Concentration - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 5 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Creatinine Clearance - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 5 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Creatinine Clearance - High | 25.0 percentage of participants |
| Part 1 SAD: Cohort 5 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Eosinophils Absolute - High | 0 percentage of participants |
| Part 1 SAD: Cohort 5 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | White Blood Cell Count - High | 0 percentage of participants |
| Part 1 SAD: Cohort 5 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Red Blood Cell Count - High | 0 percentage of participants |
| Part 1 SAD: Cohort 5 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Chloride - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 5 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Reticulocytes, Pct - High | 0 percentage of participants |
| Part 1 SAD: Cohort 5 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Cystatin C - High | 0 percentage of participants |
| Part 1 SAD: Cohort 5 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | White Blood Cell Count - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 5 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Calcium - High | 12.5 percentage of participants |
| Part 1 SAD: Cohort 6 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Creatinine Clearance - Low | 35.7 percentage of participants |
| Part 1 SAD: Cohort 6 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Neutrophils, Total, Absolute - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 6 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Hematocrit - Low | 25.0 percentage of participants |
| Part 1 SAD: Cohort 6 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Alkaline Phosphatase - High | 0 percentage of participants |
| Part 1 SAD: Cohort 6 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Chloride - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 6 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Direct Bilirubin - High | 0 percentage of participants |
| Part 1 SAD: Cohort 6 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Creatinine - High | 12.5 percentage of participants |
| Part 1 SAD: Cohort 6 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Hemoglobin - High | 0 percentage of participants |
| Part 1 SAD: Cohort 6 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Erythrocyte Mean Corpuscular HGB Concentration - Low | 12.5 percentage of participants |
| Part 1 SAD: Cohort 6 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Reticulocytes, Pct - High | 0 percentage of participants |
| Part 1 SAD: Cohort 6 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Blood Urea Nitrogen - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 6 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Erythrocyte Mean Corpuscular Volume - High | 0 percentage of participants |
| Part 1 SAD: Cohort 6 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Uric Acid - High | 16.7 percentage of participants |
| Part 1 SAD: Cohort 6 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Albumin - Low | 14.3 percentage of participants |
| Part 1 SAD: Cohort 6 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Potassium - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 6 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Sodium - High | 0 percentage of participants |
| Part 1 SAD: Cohort 6 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Blood Glucose, Fasting - High | 42.9 percentage of participants |
| Part 1 SAD: Cohort 6 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Calcium - High | 0 percentage of participants |
| Part 1 SAD: Cohort 6 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Phosphorus - High | 0 percentage of participants |
| Part 1 SAD: Cohort 6 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | White Blood Cell Count - High | 0 percentage of participants |
| Part 1 SAD: Cohort 6 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Erythrocyte Mean Corpuscular Hemoglobin - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 6 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Triglycerides, Fasting - High | 0 percentage of participants |
| Part 1 SAD: Cohort 6 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Alkaline Phosphatase - Low | 12.5 percentage of participants |
| Part 1 SAD: Cohort 6 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Cholesterol - High | 16.7 percentage of participants |
| Part 1 SAD: Cohort 6 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | SGOT/AST - High | 0 percentage of participants |
| Part 1 SAD: Cohort 6 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Eosinophils Absolute - High | 16.7 percentage of participants |
| Part 1 SAD: Cohort 6 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Red Blood Cell Count - High | 0 percentage of participants |
| Part 1 SAD: Cohort 6 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Red Blood Cell Count - Low | 12.5 percentage of participants |
| Part 1 SAD: Cohort 6 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Monocytes Absolute - High | 0 percentage of participants |
| Part 1 SAD: Cohort 6 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Bicarbonate CO2 - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 6 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Platelet - High | 0 percentage of participants |
| Part 1 SAD: Cohort 6 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Protein, Total - High | 0 percentage of participants |
| Part 1 SAD: Cohort 6 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Creatinine - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 6 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Lymphocytes Absolute - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 6 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Cystatin C - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 6 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | SGPT/ALT - High | 0 percentage of participants |
| Part 1 SAD: Cohort 6 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Protein, Total - Low | 16.7 percentage of participants |
| Part 1 SAD: Cohort 6 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Creatinine Clearance - High | 0 percentage of participants |
| Part 1 SAD: Cohort 6 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Blood Urea Nitrogen - High | 12.5 percentage of participants |
| Part 1 SAD: Cohort 6 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Cystatin C - High | 0 percentage of participants |
| Part 1 SAD: Cohort 6 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Hemoglobin - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 6 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Platelet - Low | 12.5 percentage of participants |
| Part 1 SAD: Cohort 6 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Neutrophils, Total, Absolute - High | 0 percentage of participants |
| Part 1 SAD: Cohort 6 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | White Blood Cell Count - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 7 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Protein, Total - High | 0 percentage of participants |
| Part 1 SAD: Cohort 7 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Direct Bilirubin - High | 0 percentage of participants |
| Part 1 SAD: Cohort 7 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Neutrophils, Total, Absolute - High | 12.5 percentage of participants |
| Part 1 SAD: Cohort 7 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Red Blood Cell Count - High | 0 percentage of participants |
| Part 1 SAD: Cohort 7 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | SGOT/AST - High | 12.5 percentage of participants |
| Part 1 SAD: Cohort 7 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Lymphocytes Absolute - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 7 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Hemoglobin - High | 0 percentage of participants |
| Part 1 SAD: Cohort 7 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Cholesterol - High | 14.3 percentage of participants |
| Part 1 SAD: Cohort 7 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Blood Glucose, Fasting - High | 12.5 percentage of participants |
| Part 1 SAD: Cohort 7 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Hemoglobin - Low | 25.0 percentage of participants |
| Part 1 SAD: Cohort 7 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Cystatin C - High | 12.5 percentage of participants |
| Part 1 SAD: Cohort 7 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Creatinine - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 7 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | SGPT/ALT - High | 0 percentage of participants |
| Part 1 SAD: Cohort 7 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Erythrocyte Mean Corpuscular Volume - High | 0 percentage of participants |
| Part 1 SAD: Cohort 7 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Alkaline Phosphatase - High | 0 percentage of participants |
| Part 1 SAD: Cohort 7 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Blood Urea Nitrogen - High | 0 percentage of participants |
| Part 1 SAD: Cohort 7 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Hematocrit - Low | 12.5 percentage of participants |
| Part 1 SAD: Cohort 7 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | White Blood Cell Count - High | 12.5 percentage of participants |
| Part 1 SAD: Cohort 7 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Creatinine - High | 0 percentage of participants |
| Part 1 SAD: Cohort 7 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Alkaline Phosphatase - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 7 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Reticulocytes, Pct - High | 0 percentage of participants |
| Part 1 SAD: Cohort 7 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Sodium - High | 0 percentage of participants |
| Part 1 SAD: Cohort 7 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Erythrocyte Mean Corpuscular Hemoglobin - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 7 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Triglycerides, Fasting - High | 0 percentage of participants |
| Part 1 SAD: Cohort 7 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Calcium - High | 0 percentage of participants |
| Part 1 SAD: Cohort 7 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Blood Urea Nitrogen - Low | 40.0 percentage of participants |
| Part 1 SAD: Cohort 7 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Uric Acid - High | 12.5 percentage of participants |
| Part 1 SAD: Cohort 7 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Erythrocyte Mean Corpuscular HGB Concentration - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 7 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Phosphorus - High | 12.5 percentage of participants |
| Part 1 SAD: Cohort 7 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Creatinine Clearance - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 7 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Eosinophils Absolute - High | 0 percentage of participants |
| Part 1 SAD: Cohort 7 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Albumin - Low | 12.5 percentage of participants |
| Part 1 SAD: Cohort 7 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Creatinine Clearance - High | 0 percentage of participants |
| Part 1 SAD: Cohort 7 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Cystatin C - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 7 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Platelet - High | 12.5 percentage of participants |
| Part 1 SAD: Cohort 7 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Neutrophils, Total, Absolute - Low | 12.5 percentage of participants |
| Part 1 SAD: Cohort 7 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Red Blood Cell Count - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 7 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Bicarbonate CO2 - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 7 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Potassium - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 7 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Platelet - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 7 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Chloride - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 7 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | White Blood Cell Count - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 7 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Protein, Total - Low | 28.6 percentage of participants |
| Part 1 SAD: Cohort 7 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Monocytes Absolute - High | 0 percentage of participants |
| Part 1 SAD: Cohort 8 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Creatinine Clearance - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 8 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Albumin - Low | 12.5 percentage of participants |
| Part 1 SAD: Cohort 8 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Eosinophils Absolute - High | 0 percentage of participants |
| Part 1 SAD: Cohort 8 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Bicarbonate CO2 - Low | 12.5 percentage of participants |
| Part 1 SAD: Cohort 8 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Phosphorus - High | 0 percentage of participants |
| Part 1 SAD: Cohort 8 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Direct Bilirubin - High | 0 percentage of participants |
| Part 1 SAD: Cohort 8 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Alkaline Phosphatase - High | 0 percentage of participants |
| Part 1 SAD: Cohort 8 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | SGPT/ALT - High | 12.5 percentage of participants |
| Part 1 SAD: Cohort 8 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | White Blood Cell Count - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 8 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Creatinine Clearance - High | 0 percentage of participants |
| Part 1 SAD: Cohort 8 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Creatinine - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 8 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Hemoglobin - High | 12.5 percentage of participants |
| Part 1 SAD: Cohort 8 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Platelet - High | 0 percentage of participants |
| Part 1 SAD: Cohort 8 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Neutrophils, Total, Absolute - High | 0 percentage of participants |
| Part 1 SAD: Cohort 8 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Neutrophils, Total, Absolute - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 8 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Protein, Total - Low | 12.5 percentage of participants |
| Part 1 SAD: Cohort 8 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Blood Glucose, Fasting - High | 14.3 percentage of participants |
| Part 1 SAD: Cohort 8 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Erythrocyte Mean Corpuscular Volume - High | 0 percentage of participants |
| Part 1 SAD: Cohort 8 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Cystatin C - Low | 12.5 percentage of participants |
| Part 1 SAD: Cohort 8 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Hemoglobin - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 8 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Monocytes Absolute - High | 0 percentage of participants |
| Part 1 SAD: Cohort 8 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Red Blood Cell Count - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 8 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Protein, Total - High | 12.5 percentage of participants |
| Part 1 SAD: Cohort 8 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Calcium - High | 0 percentage of participants |
| Part 1 SAD: Cohort 8 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Reticulocytes, Pct - High | 0 percentage of participants |
| Part 1 SAD: Cohort 8 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Cholesterol - High | 0 percentage of participants |
| Part 1 SAD: Cohort 8 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Triglycerides, Fasting - High | 0 percentage of participants |
| Part 1 SAD: Cohort 8 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Platelet - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 8 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Cystatin C - High | 25.0 percentage of participants |
| Part 1 SAD: Cohort 8 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Erythrocyte Mean Corpuscular HGB Concentration - Low | 12.5 percentage of participants |
| Part 1 SAD: Cohort 8 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Erythrocyte Mean Corpuscular Hemoglobin - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 8 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | SGOT/AST - High | 0 percentage of participants |
| Part 1 SAD: Cohort 8 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Sodium - High | 0 percentage of participants |
| Part 1 SAD: Cohort 8 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Alkaline Phosphatase - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 8 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Potassium - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 8 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Uric Acid - High | 0 percentage of participants |
| Part 1 SAD: Cohort 8 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Chloride - Low | 12.5 percentage of participants |
| Part 1 SAD: Cohort 8 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Creatinine - High | 0 percentage of participants |
| Part 1 SAD: Cohort 8 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Blood Urea Nitrogen - High | 0 percentage of participants |
| Part 1 SAD: Cohort 8 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Red Blood Cell Count - High | 0 percentage of participants |
| Part 1 SAD: Cohort 8 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Blood Urea Nitrogen - Low | 40.0 percentage of participants |
| Part 1 SAD: Cohort 8 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | White Blood Cell Count - High | 0 percentage of participants |
| Part 1 SAD: Cohort 8 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Hematocrit - Low | 12.5 percentage of participants |
| Part 1 SAD: Cohort 8 | Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Lymphocytes Absolute - Low | 12.5 percentage of participants |
Primary
Part 2: Percentage of Chronic Hepatitis B Participants With Abnormalities in ECG Parameters
Triplicate 12-lead ECGs were obtained after the participant has been in a supine position for at least 10 minutes. Clinically significant RO7020531-related changes included confirmation of mean QTc 500 msec or 60 msec longer than the pre-dose baseline.
Time frame: From randomization up to Week 12
Population: Safety analysis population included all participants who had received at least 1 dose of study drug. Number analyzed is the number of participants with data available for analysis at the specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1 Cohorts 1-8 SAD: Placebo | Part 2: Percentage of Chronic Hepatitis B Participants With Abnormalities in ECG Parameters | Average QTcF (12-Lead Trip.) - Low | 0 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 2: Percentage of Chronic Hepatitis B Participants With Abnormalities in ECG Parameters | Average Heart Rate (12-Lead Trip.) - High | 0 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 2: Percentage of Chronic Hepatitis B Participants With Abnormalities in ECG Parameters | Average QTcF (12-Lead Trip.) - High | 16.7 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 2: Percentage of Chronic Hepatitis B Participants With Abnormalities in ECG Parameters | Average PR (12-Lead Trip.) - Low | 0 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 2: Percentage of Chronic Hepatitis B Participants With Abnormalities in ECG Parameters | Average PR (12-Lead Trip.) - High | 0 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 2: Percentage of Chronic Hepatitis B Participants With Abnormalities in ECG Parameters | Average QTcF (12-Lead Trip.) - Low | 6.3 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 2: Percentage of Chronic Hepatitis B Participants With Abnormalities in ECG Parameters | Average PR (12-Lead Trip.) - High | 0 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 2: Percentage of Chronic Hepatitis B Participants With Abnormalities in ECG Parameters | Average PR (12-Lead Trip.) - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 2: Percentage of Chronic Hepatitis B Participants With Abnormalities in ECG Parameters | Average QTcF (12-Lead Trip.) - High | 0 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 2: Percentage of Chronic Hepatitis B Participants With Abnormalities in ECG Parameters | Average Heart Rate (12-Lead Trip.) - High | 0 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 2: Percentage of Chronic Hepatitis B Participants With Abnormalities in ECG Parameters | Average PR (12-Lead Trip.) - High | 0 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 2: Percentage of Chronic Hepatitis B Participants With Abnormalities in ECG Parameters | Average Heart Rate (12-Lead Trip.) - High | 0 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 2: Percentage of Chronic Hepatitis B Participants With Abnormalities in ECG Parameters | Average PR (12-Lead Trip.) - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 2: Percentage of Chronic Hepatitis B Participants With Abnormalities in ECG Parameters | Average QTcF (12-Lead Trip.) - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 2: Percentage of Chronic Hepatitis B Participants With Abnormalities in ECG Parameters | Average QTcF (12-Lead Trip.) - High | 0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 2: Percentage of Chronic Hepatitis B Participants With Abnormalities in ECG Parameters | Average QTcF (12-Lead Trip.) - High | 0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 2: Percentage of Chronic Hepatitis B Participants With Abnormalities in ECG Parameters | Average Heart Rate (12-Lead Trip.) - High | 0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 2: Percentage of Chronic Hepatitis B Participants With Abnormalities in ECG Parameters | Average QTcF (12-Lead Trip.) - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 2: Percentage of Chronic Hepatitis B Participants With Abnormalities in ECG Parameters | Average PR (12-Lead Trip.) - High | 20.0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 2: Percentage of Chronic Hepatitis B Participants With Abnormalities in ECG Parameters | Average PR (12-Lead Trip.) - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 4 | Part 2: Percentage of Chronic Hepatitis B Participants With Abnormalities in ECG Parameters | Average PR (12-Lead Trip.) - High | 0 percentage of participants |
| Part 1 SAD: Cohort 4 | Part 2: Percentage of Chronic Hepatitis B Participants With Abnormalities in ECG Parameters | Average QTcF (12-Lead Trip.) - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 4 | Part 2: Percentage of Chronic Hepatitis B Participants With Abnormalities in ECG Parameters | Average Heart Rate (12-Lead Trip.) - High | 6.7 percentage of participants |
| Part 1 SAD: Cohort 4 | Part 2: Percentage of Chronic Hepatitis B Participants With Abnormalities in ECG Parameters | Average QTcF (12-Lead Trip.) - High | 7.1 percentage of participants |
| Part 1 SAD: Cohort 4 | Part 2: Percentage of Chronic Hepatitis B Participants With Abnormalities in ECG Parameters | Average PR (12-Lead Trip.) - Low | 6.7 percentage of participants |
Primary
Part 2: Percentage of Chronic Hepatitis B Participants With Abnormalities in Vital Signs
Vital signs include blood pressure, pulse rate, respiratory rate and body temperature. Blood pressure, respiratory rate and pulse rate were obtained after the participant had been in a supine or sitting position for at least 5 minutes. Blood pressure measurement were performed in triplicate (can be as short as 20 second to 1 minute interval between measurements).
Time frame: From randomization up to Week 12
Population: Safety analysis population included all participants who had received at least 1 dose of study drug. Number analyzed is the number of participants with data available for analysis at the specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1 Cohorts 1-8 SAD: Placebo | Part 2: Percentage of Chronic Hepatitis B Participants With Abnormalities in Vital Signs | Respiratory Rate - High | 16.7 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 2: Percentage of Chronic Hepatitis B Participants With Abnormalities in Vital Signs | Pulse Rate - Low | 0 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 2: Percentage of Chronic Hepatitis B Participants With Abnormalities in Vital Signs | Pulse Rate - High | 0 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 2: Percentage of Chronic Hepatitis B Participants With Abnormalities in Vital Signs | Temperature - High | 0 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 2: Percentage of Chronic Hepatitis B Participants With Abnormalities in Vital Signs | Average Systolic BP - High | 50.0 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 2: Percentage of Chronic Hepatitis B Participants With Abnormalities in Vital Signs | Average Diastolic BP - High | 33.3 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 2: Percentage of Chronic Hepatitis B Participants With Abnormalities in Vital Signs | Average Diastolic BP - High | 35.7 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 2: Percentage of Chronic Hepatitis B Participants With Abnormalities in Vital Signs | Respiratory Rate - High | 6.3 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 2: Percentage of Chronic Hepatitis B Participants With Abnormalities in Vital Signs | Temperature - Low | 100.0 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 2: Percentage of Chronic Hepatitis B Participants With Abnormalities in Vital Signs | Temperature - High | 12.5 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 2: Percentage of Chronic Hepatitis B Participants With Abnormalities in Vital Signs | Pulse Rate - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 2: Percentage of Chronic Hepatitis B Participants With Abnormalities in Vital Signs | Pulse Rate - High | 0 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 2: Percentage of Chronic Hepatitis B Participants With Abnormalities in Vital Signs | Average Systolic BP - High | 31.3 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 2: Percentage of Chronic Hepatitis B Participants With Abnormalities in Vital Signs | Average Systolic BP - High | 12.5 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 2: Percentage of Chronic Hepatitis B Participants With Abnormalities in Vital Signs | Pulse Rate - High | 0 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 2: Percentage of Chronic Hepatitis B Participants With Abnormalities in Vital Signs | Average Diastolic BP - High | 12.5 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 2: Percentage of Chronic Hepatitis B Participants With Abnormalities in Vital Signs | Temperature - Low | 100.0 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 2: Percentage of Chronic Hepatitis B Participants With Abnormalities in Vital Signs | Respiratory Rate - High | 12.5 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 2: Percentage of Chronic Hepatitis B Participants With Abnormalities in Vital Signs | Pulse Rate - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 2: Percentage of Chronic Hepatitis B Participants With Abnormalities in Vital Signs | Temperature - High | 0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 2: Percentage of Chronic Hepatitis B Participants With Abnormalities in Vital Signs | Temperature - High | 0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 2: Percentage of Chronic Hepatitis B Participants With Abnormalities in Vital Signs | Average Systolic BP - High | 20.0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 2: Percentage of Chronic Hepatitis B Participants With Abnormalities in Vital Signs | Pulse Rate - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 2: Percentage of Chronic Hepatitis B Participants With Abnormalities in Vital Signs | Pulse Rate - High | 40.0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 2: Percentage of Chronic Hepatitis B Participants With Abnormalities in Vital Signs | Average Diastolic BP - High | 60.0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 2: Percentage of Chronic Hepatitis B Participants With Abnormalities in Vital Signs | Respiratory Rate - High | 0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 2: Percentage of Chronic Hepatitis B Participants With Abnormalities in Vital Signs | Temperature - Low | 100.0 percentage of participants |
| Part 1 SAD: Cohort 4 | Part 2: Percentage of Chronic Hepatitis B Participants With Abnormalities in Vital Signs | Pulse Rate - High | 40.0 percentage of participants |
| Part 1 SAD: Cohort 4 | Part 2: Percentage of Chronic Hepatitis B Participants With Abnormalities in Vital Signs | Temperature - High | 20.0 percentage of participants |
| Part 1 SAD: Cohort 4 | Part 2: Percentage of Chronic Hepatitis B Participants With Abnormalities in Vital Signs | Temperature - Low | 100.0 percentage of participants |
| Part 1 SAD: Cohort 4 | Part 2: Percentage of Chronic Hepatitis B Participants With Abnormalities in Vital Signs | Pulse Rate - Low | 6.7 percentage of participants |
| Part 1 SAD: Cohort 4 | Part 2: Percentage of Chronic Hepatitis B Participants With Abnormalities in Vital Signs | Average Systolic BP - High | 6.7 percentage of participants |
| Part 1 SAD: Cohort 4 | Part 2: Percentage of Chronic Hepatitis B Participants With Abnormalities in Vital Signs | Average Diastolic BP - High | 6.7 percentage of participants |
| Part 1 SAD: Cohort 4 | Part 2: Percentage of Chronic Hepatitis B Participants With Abnormalities in Vital Signs | Respiratory Rate - High | 6.7 percentage of participants |
Primary
Part 2: Percentage of Chronic Hepatitis B Participants With AEs
An AE is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product, any new disease or exacerbation of an existing disease (a worsening in the character, frequency, or severity of a known condition and recurrence of an intermittent medical condition (e.g., headache) not present at baseline.
Time frame: From randomization up to Week 12
Population: Safety analysis population included all participants who had received at least 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1 Cohorts 1-8 SAD: Placebo | Part 2: Percentage of Chronic Hepatitis B Participants With AEs | 50.0 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 2: Percentage of Chronic Hepatitis B Participants With AEs | 68.8 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 2: Percentage of Chronic Hepatitis B Participants With AEs | 75.0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 2: Percentage of Chronic Hepatitis B Participants With AEs | 60.0 percentage of participants |
| Part 1 SAD: Cohort 4 | Part 2: Percentage of Chronic Hepatitis B Participants With AEs | 80.0 percentage of participants |
Primary
Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
For all laboratory parameters included, there exists a Roche predefined standard reference range. Laboratory values falling outside this standard reference range were labeled H for high or L for low in HV/participant listings of laboratory data.
Time frame: From randomization up to Week 12
Population: Safety analysis population included all HVs who had received at least 1 dose of study drug. Number analyzed is the number of participants with data available for analysis at the specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1 Cohorts 1-8 SAD: Placebo | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Calcium - Low | 0 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Protein, Total - Low | 0 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Phosphorus - High | 0 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | White Blood Cell Count - High | 0 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Triglycerides, Fasting - High | 16.7 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Potassium - High | 33.3 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Uric Acid - High | 0 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Activated Partial Thromboplastin Time - High | 0 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Erythrocyte Mean Corpuscular Volume - High | 0 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | International Normalized Ratio - High | 16.7 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Indirect Bilirubin - High | 0 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Bicarbonate CO2 - Low | 0 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Sodium - High | 0 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Bicarbonate CO2 - High | 0 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Lymphocytes Absolute - High | 0 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Monocytes Absolute - High | 16.7 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Chloride - Low | 0 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Eosinophil Absolute - High | 0 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Creatinine - High | 0 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Chloride - High | 16.7 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Cystatin C - High | 20.0 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Indirect Bilirubin - Low | 16.7 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Red Blood Cell Count - Low | 0 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Reticulocytes, Pct - High | 0 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | White Blood Cell Count - Low | 20.0 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | SGPT/ALT - High | 16.7 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Prothrombin Time - High | 20.0 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Cholesterol - High | 0 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Phosphorus - Low | 0 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Lymphocytes Absolute - Low | 16.7 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Neutrophils, Total, Absolute - Low | 20.0 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | SGOT/AST - High | 0 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Neutrophils, Total, Absolute - High | 0 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Platelet - Low | 0 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Bilirubin - High | 0 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Protein, Total - High | 0 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Blood Glucose, Fasting - Low | 16.7 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Blood Glucose, Fasting - High | 16.7 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Monocytes Absolute - Low | 16.7 percentage of participants |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Blood Urea Nitrogen - High | 33.3 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Monocytes Absolute - Low | 8.3 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Calcium - Low | 6.3 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Phosphorus - Low | 43.8 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Monocytes Absolute - High | 6.3 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Bicarbonate CO2 - High | 6.3 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Phosphorus - High | 6.3 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Bilirubin - High | 6.3 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Indirect Bilirubin - High | 6.3 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Red Blood Cell Count - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Sodium - High | 0 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Chloride - High | 0 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Eosinophil Absolute - High | 6.3 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Potassium - High | 6.3 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Prothrombin Time - High | 30.8 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Triglycerides, Fasting - High | 50.0 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Chloride - Low | 13.3 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | White Blood Cell Count - High | 6.3 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | SGOT/AST - High | 6.7 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Reticulocytes, Pct - High | 6.3 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Uric Acid - High | 6.7 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Lymphocytes Absolute - High | 0 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Protein, Total - High | 6.7 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | White Blood Cell Count - Low | 46.2 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Neutrophils, Total, Absolute - Low | 35.7 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Activated Partial Thromboplastin Time - High | 6.7 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Protein, Total - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Indirect Bilirubin - Low | 18.8 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | International Normalized Ratio - High | 0 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Lymphocytes Absolute - Low | 25.0 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Cystatin C - High | 26.7 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Blood Glucose, Fasting - High | 35.7 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Bicarbonate CO2 - Low | 6.3 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Platelet - Low | 18.8 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Erythrocyte Mean Corpuscular Volume - High | 6.7 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Neutrophils, Total, Absolute - High | 6.3 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Blood Urea Nitrogen - High | 26.7 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | SGPT/ALT - High | 6.3 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Creatinine - High | 7.1 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Cholesterol - High | 14.3 percentage of participants |
| Part 1 SAD: Cohort 1 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Blood Glucose, Fasting - Low | 12.5 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Creatinine - High | 0 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Calcium - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Blood Glucose, Fasting - High | 0 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Chloride - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Platelet - Low | 12.5 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Lymphocytes Absolute - High | 0 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Chloride - High | 0 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Cholesterol - High | 25.0 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Cystatin C - High | 0 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | White Blood Cell Count - Low | 42.9 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Prothrombin Time - High | 14.3 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Red Blood Cell Count - Low | 12.5 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Bilirubin - High | 0 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Reticulocytes, Pct - High | 12.5 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Phosphorus - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Indirect Bilirubin - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Erythrocyte Mean Corpuscular Volume - High | 0 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Eosinophil Absolute - High | 0 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | SGOT/AST - High | 0 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Monocytes Absolute - High | 0 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Blood Glucose, Fasting - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Phosphorus - High | 0 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Potassium - High | 12.5 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Sodium - High | 12.5 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Bicarbonate CO2 - High | 0 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Indirect Bilirubin - High | 0 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Triglycerides, Fasting - High | 12.5 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Protein, Total - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Uric Acid - High | 12.5 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | White Blood Cell Count - High | 0 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | International Normalized Ratio - High | 0 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Activated Partial Thromboplastin Time - High | 0 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Neutrophils, Total, Absolute - Low | 62.5 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Blood Urea Nitrogen - High | 12.5 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Bicarbonate CO2 - Low | 12.5 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Neutrophils, Total, Absolute - High | 0 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Monocytes Absolute - Low | 14.3 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Lymphocytes Absolute - Low | 25.0 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | SGPT/ALT - High | 0 percentage of participants |
| Part 1 SAD: Cohort 2 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Protein, Total - High | 12.5 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Chloride - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Erythrocyte Mean Corpuscular HGB Concentration - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | White Blood Cell Count - Low | 20.0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Hemoglobin - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Lymphocytes Absolute - High | 20.0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Lymphocytes Absolute - Low | 20.0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | White Blood Cell Count - High | 0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Bicarbonate CO2 - Low | 20.0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Monocytes Absolute - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Calcium - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Cystatin C - High | 0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Red Blood Cell Count - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Indirect Bilirubin - Low | 50.0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Chloride - High | 20.0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Monocytes Absolute - High | 0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Bicarbonate CO2 - High | 0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Neutrophils, Total, Absolute - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Neutrophils, Total, Absolute - High | 0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Platelet - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Bilirubin - High | 0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Blood Glucose, Fasting - Low | 20.0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Blood Glucose, Fasting - High | 0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Blood Urea Nitrogen - High | 0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Phosphorus - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Phosphorus - High | 20.0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Sodium - High | 20.0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Triglycerides, Fasting - High | 50.0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Uric Acid - High | 0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Activated Partial Thromboplastin Time - High | 0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | International Normalized Ratio - High | 0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Potassium - High | 40.0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Protein, Total - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Protein, Total - High | 20.0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | SGOT/AST - High | 0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Prothrombin Time - High | 66.7 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Cholesterol - High | 80.0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Creatinine - High | 20.0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | SGPT/ALT - High | 25.0 percentage of participants |
| Part 1 SAD: Cohort 3 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Indirect Bilirubin - High | 0 percentage of participants |
| Part 1 SAD: Cohort 4 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Blood Urea Nitrogen - High | 6.7 percentage of participants |
| Part 1 SAD: Cohort 4 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Blood Glucose, Fasting - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 4 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | White Blood Cell Count - High | 0 percentage of participants |
| Part 1 SAD: Cohort 4 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Protein, Total - Low | 6.7 percentage of participants |
| Part 1 SAD: Cohort 4 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Bilirubin - High | 7.1 percentage of participants |
| Part 1 SAD: Cohort 4 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Bicarbonate CO2 - High | 6.7 percentage of participants |
| Part 1 SAD: Cohort 4 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Neutrophils, Total, Absolute - High | 0 percentage of participants |
| Part 1 SAD: Cohort 4 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | White Blood Cell Count - Low | 50.0 percentage of participants |
| Part 1 SAD: Cohort 4 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Protein, Total - High | 0 percentage of participants |
| Part 1 SAD: Cohort 4 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Neutrophils, Total, Absolute - Low | 46.2 percentage of participants |
| Part 1 SAD: Cohort 4 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Monocytes Absolute - High | 0 percentage of participants |
| Part 1 SAD: Cohort 4 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Chloride - High | 0 percentage of participants |
| Part 1 SAD: Cohort 4 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Lymphocytes Absolute - High | 0 percentage of participants |
| Part 1 SAD: Cohort 4 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | SGOT/AST - High | 42.9 percentage of participants |
| Part 1 SAD: Cohort 4 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Indirect Bilirubin - Low | 53.3 percentage of participants |
| Part 1 SAD: Cohort 4 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Red Blood Cell Count - Low | 6.7 percentage of participants |
| Part 1 SAD: Cohort 4 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Platelet - Low | 6.7 percentage of participants |
| Part 1 SAD: Cohort 4 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Lymphocytes Absolute - Low | 13.3 percentage of participants |
| Part 1 SAD: Cohort 4 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Prothrombin Time - High | 41.7 percentage of participants |
| Part 1 SAD: Cohort 4 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Cystatin C - High | 6.7 percentage of participants |
| Part 1 SAD: Cohort 4 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Creatinine - High | 0 percentage of participants |
| Part 1 SAD: Cohort 4 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Indirect Bilirubin - High | 7.1 percentage of participants |
| Part 1 SAD: Cohort 4 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Cholesterol - High | 12.5 percentage of participants |
| Part 1 SAD: Cohort 4 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Chloride - Low | 0 percentage of participants |
| Part 1 SAD: Cohort 4 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Calcium - Low | 6.7 percentage of participants |
| Part 1 SAD: Cohort 4 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Blood Glucose, Fasting - High | 14.3 percentage of participants |
| Part 1 SAD: Cohort 4 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Hemoglobin - Low | 6.7 percentage of participants |
| Part 1 SAD: Cohort 4 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Monocytes Absolute - Low | 26.7 percentage of participants |
| Part 1 SAD: Cohort 4 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Erythrocyte Mean Corpuscular HGB Concentration - Low | 6.7 percentage of participants |
| Part 1 SAD: Cohort 4 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Activated Partial Thromboplastin Time - High | 13.3 percentage of participants |
| Part 1 SAD: Cohort 4 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Uric Acid - High | 14.3 percentage of participants |
| Part 1 SAD: Cohort 4 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | SGPT/ALT - High | 36.4 percentage of participants |
| Part 1 SAD: Cohort 4 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | International Normalized Ratio - High | 14.3 percentage of participants |
| Part 1 SAD: Cohort 4 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Triglycerides, Fasting - High | 14.3 percentage of participants |
| Part 1 SAD: Cohort 4 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Sodium - High | 0 percentage of participants |
| Part 1 SAD: Cohort 4 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Phosphorus - High | 7.1 percentage of participants |
| Part 1 SAD: Cohort 4 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Bicarbonate CO2 - Low | 7.1 percentage of participants |
| Part 1 SAD: Cohort 4 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Potassium - High | 13.3 percentage of participants |
| Part 1 SAD: Cohort 4 | Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results | Phosphorus - Low | 6.7 percentage of participants |
Secondary
Effect of RO7020531 Dosing on ECG Parameters (PR [PQ], QRS, QT, QTcF in Miliseconds [ms]) Using Exposure-response Analysis: SAD and MAD
Time frame: SAD: Predose, 0.5, 1, 2, 4, 6, 12, 24 and 48 hrs Post dose on Day 1; MAD: Predose, 0.5, 1,2,4 and 12 hrs Postdose on Day 1 and 13; Predose, 2 and 6 hrs Postdose on Day 3, Predose, 6 and 24 hrs Postdose on Day , 7, 9, and 11
Population: Data was not collected for this Outcome Measure due to change in planned analyses. This analysis will be performed after CSR finalization, as its results will only be required before executing a Phase 3 study with RO7020531.
Secondary
Part 1: Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUCinf) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD
Time frame: SAD: Predose and 0.5, 1, 1.5 , 2, 3, 4, 6,8, 12,18, and 24hours post dose on Day 1; MAD: Predose and 0.25, 0.5, 1, 1.5, 2 , 3, 4, 6, 8, 12,18, and 24 hours post dose on Days 1 and 13
Population: The PK analysis population included all HVs randomized and adherent to the protocol. Number analyzed is the number of participants available at the specific timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUCinf) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7011785: Day 1 | 50.9 hours*nanogram per milliliter (h*ng/mL) | Standard Deviation 28.9 |
| Part 1 SAD: Cohort 1 | Part 1: Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUCinf) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7018822: Day 1 | 8.59 hours*nanogram per milliliter (h*ng/mL) | Standard Deviation 2.61 |
| Part 1 SAD: Cohort 1 | Part 1: Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUCinf) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7011785: Day 1 | 138 hours*nanogram per milliliter (h*ng/mL) | Standard Deviation 40.8 |
| Part 1 SAD: Cohort 2 | Part 1: Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUCinf) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7011785: Day 1 | 253 hours*nanogram per milliliter (h*ng/mL) | Standard Deviation 58.3 |
| Part 1 SAD: Cohort 2 | Part 1: Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUCinf) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7018822: Day 1 | 19.0 hours*nanogram per milliliter (h*ng/mL) | Standard Deviation 5.66 |
| Part 1 SAD: Cohort 3 | Part 1: Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUCinf) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7018822: Day 1 | 43.3 hours*nanogram per milliliter (h*ng/mL) | Standard Deviation 15.5 |
| Part 1 SAD: Cohort 3 | Part 1: Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUCinf) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7011785: Day 1 | 596 hours*nanogram per milliliter (h*ng/mL) | Standard Deviation 103 |
| Part 1 SAD: Cohort 4 | Part 1: Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUCinf) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7018822: Day 1 | 49.1 hours*nanogram per milliliter (h*ng/mL) | Standard Deviation 19.9 |
| Part 1 SAD: Cohort 4 | Part 1: Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUCinf) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7011785: Day 1 | 770 hours*nanogram per milliliter (h*ng/mL) | Standard Deviation 113 |
| Part 1 SAD: Cohort 5 | Part 1: Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUCinf) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7011785: Day 1 | 1600 hours*nanogram per milliliter (h*ng/mL) | Standard Deviation 228 |
| Part 1 SAD: Cohort 5 | Part 1: Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUCinf) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7018822: Day 1 | 95.4 hours*nanogram per milliliter (h*ng/mL) | Standard Deviation 21.3 |
| Part 1 SAD: Cohort 6 | Part 1: Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUCinf) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7018822: Day 1 | 139 hours*nanogram per milliliter (h*ng/mL) | Standard Deviation 40.2 |
| Part 1 SAD: Cohort 6 | Part 1: Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUCinf) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7011785: Day 1 | 2190 hours*nanogram per milliliter (h*ng/mL) | Standard Deviation 532 |
| Part 1 SAD: Cohort 7 | Part 1: Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUCinf) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7011785: Day 1 | 2690 hours*nanogram per milliliter (h*ng/mL) | Standard Deviation 857 |
| Part 1 SAD: Cohort 7 | Part 1: Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUCinf) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7018822: Day 1 | 224 hours*nanogram per milliliter (h*ng/mL) | Standard Deviation 81.6 |
| Part 1 SAD: Cohort 8 | Part 1: Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUCinf) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7018822: Day 1 | 97.4 hours*nanogram per milliliter (h*ng/mL) | Standard Deviation 32.2 |
| Part 1 SAD: Cohort 8 | Part 1: Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUCinf) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7018822: Day 13 | 84.5 hours*nanogram per milliliter (h*ng/mL) | Standard Deviation 24 |
| Part 1 SAD: Cohort 8 | Part 1: Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUCinf) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7011785: Day 1 | 1450 hours*nanogram per milliliter (h*ng/mL) | Standard Deviation 278 |
| Part 1 SAD: Cohort 8 | Part 1: Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUCinf) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7011785: Day 13 | 1420 hours*nanogram per milliliter (h*ng/mL) | Standard Deviation 288 |
| Part 1 MAD: Cohort 2 | Part 1: Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUCinf) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7018822: Day 1 | 164 hours*nanogram per milliliter (h*ng/mL) | Standard Deviation 53.6 |
| Part 1 MAD: Cohort 2 | Part 1: Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUCinf) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7018822: Day 13 | 158 hours*nanogram per milliliter (h*ng/mL) | Standard Deviation 42.1 |
| Part 1 MAD: Cohort 2 | Part 1: Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUCinf) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7011785: Day 1 | 2250 hours*nanogram per milliliter (h*ng/mL) | Standard Deviation 838 |
| Part 1 MAD: Cohort 2 | Part 1: Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUCinf) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7011785: Day 13 | 2150 hours*nanogram per milliliter (h*ng/mL) | Standard Deviation 734 |
| Part 1 MAD: Cohort 3 | Part 1: Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUCinf) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7011785: Day 13 | 2730 hours*nanogram per milliliter (h*ng/mL) | Standard Deviation 472 |
| Part 1 MAD: Cohort 3 | Part 1: Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUCinf) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7011785: Day 1 | 2700 hours*nanogram per milliliter (h*ng/mL) | Standard Deviation 572 |
| Part 1 MAD: Cohort 3 | Part 1: Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUCinf) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7018822: Day 13 | 216 hours*nanogram per milliliter (h*ng/mL) | Standard Deviation 71.4 |
| Part 1 MAD: Cohort 3 | Part 1: Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUCinf) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7018822: Day 1 | 231 hours*nanogram per milliliter (h*ng/mL) | Standard Deviation 110 |
| Unknown | Part 1: Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUCinf) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7033805: Day 13 | — hours*nanogram per milliliter (h*ng/mL) | — |
| Unknown | Part 1: Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUCinf) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7033805: Day 1 | — hours*nanogram per milliliter (h*ng/mL) | — |
| Unknown | Part 1: Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUCinf) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7020531: Day 13 | — hours*nanogram per milliliter (h*ng/mL) | — |
| Unknown | Part 1: Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUCinf) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7020531: Day 1 | — hours*nanogram per milliliter (h*ng/mL) | — |
Secondary
Part 1: Area Under the Plasma Concentration Versus Time Curve up to the Last Measurable Concentration (AUClast) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD
Time frame: SAD: Predose and 0.5, 1, 1.5 , 2, 3, 4, 6,8, 12,18, and 24hours post dose on Day 1; MAD: Predose and 0.25, 0.5, 1, 1.5, 2 , 3, 4, 6, 8, 12,18, and 24 hours post dose on Days 1 and 13
Population: The PK analysis population included all HVs randomized and adherent to the protocol. Number analyzed is the number of participants available at the specific timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Area Under the Plasma Concentration Versus Time Curve up to the Last Measurable Concentration (AUClast) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7011785: Day 1 | 48.2 h*ng/mL | Standard Deviation 27.3 |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Area Under the Plasma Concentration Versus Time Curve up to the Last Measurable Concentration (AUClast) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7018822: Day 1 | 1.43 h*ng/mL | Standard Deviation 1.47 |
| Part 1 SAD: Cohort 1 | Part 1: Area Under the Plasma Concentration Versus Time Curve up to the Last Measurable Concentration (AUClast) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7018822: Day 1 | 6.73 h*ng/mL | Standard Deviation 2.81 |
| Part 1 SAD: Cohort 1 | Part 1: Area Under the Plasma Concentration Versus Time Curve up to the Last Measurable Concentration (AUClast) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7011785: Day 1 | 135 h*ng/mL | Standard Deviation 40.1 |
| Part 1 SAD: Cohort 2 | Part 1: Area Under the Plasma Concentration Versus Time Curve up to the Last Measurable Concentration (AUClast) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7018822: Day 1 | 16.4 h*ng/mL | Standard Deviation 5.96 |
| Part 1 SAD: Cohort 2 | Part 1: Area Under the Plasma Concentration Versus Time Curve up to the Last Measurable Concentration (AUClast) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7011785: Day 1 | 249 h*ng/mL | Standard Deviation 58.8 |
| Part 1 SAD: Cohort 3 | Part 1: Area Under the Plasma Concentration Versus Time Curve up to the Last Measurable Concentration (AUClast) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7011785: Day 1 | 587 h*ng/mL | Standard Deviation 104 |
| Part 1 SAD: Cohort 3 | Part 1: Area Under the Plasma Concentration Versus Time Curve up to the Last Measurable Concentration (AUClast) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7018822: Day 1 | 41.6 h*ng/mL | Standard Deviation 15.5 |
| Part 1 SAD: Cohort 4 | Part 1: Area Under the Plasma Concentration Versus Time Curve up to the Last Measurable Concentration (AUClast) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7011785: Day 1 | 763 h*ng/mL | Standard Deviation 114 |
| Part 1 SAD: Cohort 4 | Part 1: Area Under the Plasma Concentration Versus Time Curve up to the Last Measurable Concentration (AUClast) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7018822: Day 1 | 48.5 h*ng/mL | Standard Deviation 19.1 |
| Part 1 SAD: Cohort 5 | Part 1: Area Under the Plasma Concentration Versus Time Curve up to the Last Measurable Concentration (AUClast) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7018822: Day 1 | 93.8 h*ng/mL | Standard Deviation 21.7 |
| Part 1 SAD: Cohort 5 | Part 1: Area Under the Plasma Concentration Versus Time Curve up to the Last Measurable Concentration (AUClast) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7011785: Day 1 | 1590 h*ng/mL | Standard Deviation 227 |
| Part 1 SAD: Cohort 6 | Part 1: Area Under the Plasma Concentration Versus Time Curve up to the Last Measurable Concentration (AUClast) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7018822: Day 1 | 143 h*ng/mL | Standard Deviation 41.2 |
| Part 1 SAD: Cohort 6 | Part 1: Area Under the Plasma Concentration Versus Time Curve up to the Last Measurable Concentration (AUClast) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7011785: Day 1 | 2180 h*ng/mL | Standard Deviation 533 |
| Part 1 SAD: Cohort 7 | Part 1: Area Under the Plasma Concentration Versus Time Curve up to the Last Measurable Concentration (AUClast) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7033805: Day 1 | 0.285 h*ng/mL | — |
| Part 1 SAD: Cohort 7 | Part 1: Area Under the Plasma Concentration Versus Time Curve up to the Last Measurable Concentration (AUClast) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7011785: Day 1 | 2680 h*ng/mL | Standard Deviation 857 |
| Part 1 SAD: Cohort 7 | Part 1: Area Under the Plasma Concentration Versus Time Curve up to the Last Measurable Concentration (AUClast) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7018822: Day 1 | 222 h*ng/mL | Standard Deviation 81.6 |
| Part 1 SAD: Cohort 8 | Part 1: Area Under the Plasma Concentration Versus Time Curve up to the Last Measurable Concentration (AUClast) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7018822: Day 13 | 80.6 h*ng/mL | Standard Deviation 23.5 |
| Part 1 SAD: Cohort 8 | Part 1: Area Under the Plasma Concentration Versus Time Curve up to the Last Measurable Concentration (AUClast) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7033805: Day 1 | 0.155 h*ng/mL | — |
| Part 1 SAD: Cohort 8 | Part 1: Area Under the Plasma Concentration Versus Time Curve up to the Last Measurable Concentration (AUClast) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7011785: Day 1 | 1440 h*ng/mL | Standard Deviation 276 |
| Part 1 SAD: Cohort 8 | Part 1: Area Under the Plasma Concentration Versus Time Curve up to the Last Measurable Concentration (AUClast) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7011785: Day 13 | 1410 h*ng/mL | Standard Deviation 288 |
| Part 1 SAD: Cohort 8 | Part 1: Area Under the Plasma Concentration Versus Time Curve up to the Last Measurable Concentration (AUClast) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7018822: Day 1 | 95.9 h*ng/mL | Standard Deviation 32.3 |
| Part 1 MAD: Cohort 2 | Part 1: Area Under the Plasma Concentration Versus Time Curve up to the Last Measurable Concentration (AUClast) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7011785: Day 1 | 2240 h*ng/mL | Standard Deviation 837 |
| Part 1 MAD: Cohort 2 | Part 1: Area Under the Plasma Concentration Versus Time Curve up to the Last Measurable Concentration (AUClast) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7018822: Day 13 | 154 h*ng/mL | Standard Deviation 39.7 |
| Part 1 MAD: Cohort 2 | Part 1: Area Under the Plasma Concentration Versus Time Curve up to the Last Measurable Concentration (AUClast) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7018822: Day 1 | 161 h*ng/mL | Standard Deviation 52.9 |
| Part 1 MAD: Cohort 2 | Part 1: Area Under the Plasma Concentration Versus Time Curve up to the Last Measurable Concentration (AUClast) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7011785: Day 13 | 2150 h*ng/mL | Standard Deviation 733 |
| Part 1 MAD: Cohort 3 | Part 1: Area Under the Plasma Concentration Versus Time Curve up to the Last Measurable Concentration (AUClast) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7033805: Day 13 | 0.316 h*ng/mL | Standard Deviation 0.155 |
| Part 1 MAD: Cohort 3 | Part 1: Area Under the Plasma Concentration Versus Time Curve up to the Last Measurable Concentration (AUClast) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7011785: Day 1 | 2690 h*ng/mL | Standard Deviation 573 |
| Part 1 MAD: Cohort 3 | Part 1: Area Under the Plasma Concentration Versus Time Curve up to the Last Measurable Concentration (AUClast) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7011785: Day 13 | 2720 h*ng/mL | Standard Deviation 472 |
| Part 1 MAD: Cohort 3 | Part 1: Area Under the Plasma Concentration Versus Time Curve up to the Last Measurable Concentration (AUClast) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7018822: Day 1 | 228 h*ng/mL | Standard Deviation 109 |
| Part 1 MAD: Cohort 3 | Part 1: Area Under the Plasma Concentration Versus Time Curve up to the Last Measurable Concentration (AUClast) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7018822: Day 13 | 210 h*ng/mL | Standard Deviation 64.9 |
| Part 1 MAD: Cohort 3 | Part 1: Area Under the Plasma Concentration Versus Time Curve up to the Last Measurable Concentration (AUClast) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7033805: Day 1 | 0.434 h*ng/mL | Standard Deviation 0.224 |
| Part 1 MAD: Cohort 3 | Part 1: Area Under the Plasma Concentration Versus Time Curve up to the Last Measurable Concentration (AUClast) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7020531: Day 1 | 0.234 h*ng/mL | — |
Secondary
Part 1: Half Life (t1/2) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD
Time frame: SAD: Predose and 0.5, 1, 1.5 , 2, 3, 4, 6,8, 12,18, and 24hours post dose on Day 1; MAD: Predose and 0.25, 0.5, 1, 1.5, 2 , 3, 4, 6, 8, 12,18, and 24 hours post dose on Days 1 and 13
Population: The PK analysis population included all HVs randomized and adherent to the protocol. Number analyzed is the number of participants available at the specific timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Half Life (t1/2) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7011785: Day 1 | 1.11 hr | Standard Deviation 0.37 |
| Part 1 SAD: Cohort 1 | Part 1: Half Life (t1/2) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7018822: Day 1 | 0.610 hr | Standard Deviation 0.0986 |
| Part 1 SAD: Cohort 1 | Part 1: Half Life (t1/2) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7011785: Day 1 | 1.56 hr | Standard Deviation 0.319 |
| Part 1 SAD: Cohort 2 | Part 1: Half Life (t1/2) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7018822: Day 1 | 0.655 hr | Standard Deviation 0.276 |
| Part 1 SAD: Cohort 2 | Part 1: Half Life (t1/2) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7011785: Day 1 | 1.81 hr | Standard Deviation 0.506 |
| Part 1 SAD: Cohort 3 | Part 1: Half Life (t1/2) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7011785: Day 1 | 2.78 hr | Standard Deviation 0.479 |
| Part 1 SAD: Cohort 3 | Part 1: Half Life (t1/2) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7018822: Day 1 | 0.579 hr | Standard Deviation 0.144 |
| Part 1 SAD: Cohort 4 | Part 1: Half Life (t1/2) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7018822: Day 1 | 0.567 hr | Standard Deviation 0.19 |
| Part 1 SAD: Cohort 4 | Part 1: Half Life (t1/2) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7011785: Day 1 | 2.82 hr | Standard Deviation 0.599 |
| Part 1 SAD: Cohort 5 | Part 1: Half Life (t1/2) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7018822: Day 1 | 0.585 hr | Standard Deviation 0.078 |
| Part 1 SAD: Cohort 5 | Part 1: Half Life (t1/2) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7011785: Day 1 | 3.35 hr | Standard Deviation 0.573 |
| Part 1 SAD: Cohort 6 | Part 1: Half Life (t1/2) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7018822: Day 1 | 0.564 hr | Standard Deviation 0.0827 |
| Part 1 SAD: Cohort 6 | Part 1: Half Life (t1/2) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7011785: Day 1 | 3.26 hr | Standard Deviation 0.254 |
| Part 1 SAD: Cohort 7 | Part 1: Half Life (t1/2) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7011785: Day 1 | 3.39 hr | Standard Deviation 0.616 |
| Part 1 SAD: Cohort 7 | Part 1: Half Life (t1/2) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7018822: Day 1 | 0.645 hr | Standard Deviation 0.137 |
| Part 1 SAD: Cohort 8 | Part 1: Half Life (t1/2) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7018822: Day 13 | 0.578 hr | Standard Deviation 0.0528 |
| Part 1 SAD: Cohort 8 | Part 1: Half Life (t1/2) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7011785: Day 1 | 3.23 hr | Standard Deviation 0.635 |
| Part 1 SAD: Cohort 8 | Part 1: Half Life (t1/2) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7011785: Day 13 | 3.63 hr | Standard Deviation 0.74 |
| Part 1 SAD: Cohort 8 | Part 1: Half Life (t1/2) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7018822: Day 1 | 0.548 hr | Standard Deviation 0.111 |
| Part 1 MAD: Cohort 2 | Part 1: Half Life (t1/2) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7011785: Day 13 | 3.23 hr | Standard Deviation 0.528 |
| Part 1 MAD: Cohort 2 | Part 1: Half Life (t1/2) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7018822: Day 1 | 0.586 hr | Standard Deviation 0.0507 |
| Part 1 MAD: Cohort 2 | Part 1: Half Life (t1/2) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7018822: Day 13 | 0.620 hr | Standard Deviation 0.0812 |
| Part 1 MAD: Cohort 2 | Part 1: Half Life (t1/2) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7011785: Day 1 | 2.80 hr | Standard Deviation 0.538 |
| Part 1 MAD: Cohort 3 | Part 1: Half Life (t1/2) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7018822: Day 13 | 0.744 hr | Standard Deviation 0.204 |
| Part 1 MAD: Cohort 3 | Part 1: Half Life (t1/2) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7011785: Day 1 | 3.00 hr | Standard Deviation 0.692 |
| Part 1 MAD: Cohort 3 | Part 1: Half Life (t1/2) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7011785: Day 13 | 3.45 hr | Standard Deviation 1.12 |
| Part 1 MAD: Cohort 3 | Part 1: Half Life (t1/2) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7018822: Day 1 | 0.601 hr | Standard Deviation 0.113 |
| Unknown | Part 1: Half Life (t1/2) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7020531: Day 1 | — hr | — |
| Unknown | Part 1: Half Life (t1/2) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7033805: Day 1 | — hr | — |
| Unknown | Part 1: Half Life (t1/2) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7020531: Day 13 | — hr | — |
| Unknown | Part 1: Half Life (t1/2) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7033805: Day 13 | — hr | — |
Secondary
Part 1: Maximum Observed Plasma Concentration (Cmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD
Time frame: SAD: Predose and 0.5, 1, 1.5 , 2, 3, 4, 6,8, 12,18, and 24hours post dose on Day 1; MAD: Predose and 0.25, 0.5, 1, 1.5, 2 , 3, 4, 6, 8, 12,18, and 24 hours post dose on Days 1 and 13
Population: The Pharmacokinetic (PK) analysis population included all HVs randomized and adherent to the protocol. Number analyzed is the number of participants available at the specific timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Maximum Observed Plasma Concentration (Cmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7011785: Day 1 | 30.2 nanograms per milliliter (ng/mL) | Standard Deviation 10.4 |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Maximum Observed Plasma Concentration (Cmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7020531: Day 1 | 0.00 nanograms per milliliter (ng/mL) | Standard Deviation 0 |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Maximum Observed Plasma Concentration (Cmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7033805: Day 1 | 0.00 nanograms per milliliter (ng/mL) | Standard Deviation 0 |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Maximum Observed Plasma Concentration (Cmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7018822: Day 1 | 2.01 nanograms per milliliter (ng/mL) | Standard Deviation 1.12 |
| Part 1 SAD: Cohort 1 | Part 1: Maximum Observed Plasma Concentration (Cmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7020531: Day 1 | 0.00 nanograms per milliliter (ng/mL) | Standard Deviation 0 |
| Part 1 SAD: Cohort 1 | Part 1: Maximum Observed Plasma Concentration (Cmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7018822: Day 1 | 8.96 nanograms per milliliter (ng/mL) | Standard Deviation 5.15 |
| Part 1 SAD: Cohort 1 | Part 1: Maximum Observed Plasma Concentration (Cmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7011785: Day 1 | 115 nanograms per milliliter (ng/mL) | Standard Deviation 69 |
| Part 1 SAD: Cohort 1 | Part 1: Maximum Observed Plasma Concentration (Cmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7033805: Day 1 | 0.00 nanograms per milliliter (ng/mL) | Standard Deviation 0 |
| Part 1 SAD: Cohort 2 | Part 1: Maximum Observed Plasma Concentration (Cmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7033805: Day 1 | 0.00 nanograms per milliliter (ng/mL) | Standard Deviation 0 |
| Part 1 SAD: Cohort 2 | Part 1: Maximum Observed Plasma Concentration (Cmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7018822: Day 1 | 20.0 nanograms per milliliter (ng/mL) | Standard Deviation 16 |
| Part 1 SAD: Cohort 2 | Part 1: Maximum Observed Plasma Concentration (Cmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7011785: Day 1 | 182 nanograms per milliliter (ng/mL) | Standard Deviation 71.4 |
| Part 1 SAD: Cohort 2 | Part 1: Maximum Observed Plasma Concentration (Cmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7020531: Day 1 | 0.00 nanograms per milliliter (ng/mL) | Standard Deviation 0 |
| Part 1 SAD: Cohort 3 | Part 1: Maximum Observed Plasma Concentration (Cmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7011785: Day 1 | 508 nanograms per milliliter (ng/mL) | Standard Deviation 203 |
| Part 1 SAD: Cohort 3 | Part 1: Maximum Observed Plasma Concentration (Cmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7033805: Day 1 | 0.00 nanograms per milliliter (ng/mL) | Standard Deviation 0 |
| Part 1 SAD: Cohort 3 | Part 1: Maximum Observed Plasma Concentration (Cmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7020531: Day 1 | 0.00 nanograms per milliliter (ng/mL) | Standard Deviation 0 |
| Part 1 SAD: Cohort 3 | Part 1: Maximum Observed Plasma Concentration (Cmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7018822: Day 1 | 52.3 nanograms per milliliter (ng/mL) | Standard Deviation 24.9 |
| Part 1 SAD: Cohort 4 | Part 1: Maximum Observed Plasma Concentration (Cmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7033805: Day 1 | 0.00 nanograms per milliliter (ng/mL) | Standard Deviation 0 |
| Part 1 SAD: Cohort 4 | Part 1: Maximum Observed Plasma Concentration (Cmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7011785: Day 1 | 598 nanograms per milliliter (ng/mL) | Standard Deviation 218 |
| Part 1 SAD: Cohort 4 | Part 1: Maximum Observed Plasma Concentration (Cmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7018822: Day 1 | 54.4 nanograms per milliliter (ng/mL) | Standard Deviation 32.1 |
| Part 1 SAD: Cohort 4 | Part 1: Maximum Observed Plasma Concentration (Cmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7020531: Day 1 | 0.00 nanograms per milliliter (ng/mL) | Standard Deviation 0 |
| Part 1 SAD: Cohort 5 | Part 1: Maximum Observed Plasma Concentration (Cmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7011785: Day 1 | 1270 nanograms per milliliter (ng/mL) | Standard Deviation 505 |
| Part 1 SAD: Cohort 5 | Part 1: Maximum Observed Plasma Concentration (Cmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7020531: Day 1 | 0.00 nanograms per milliliter (ng/mL) | Standard Deviation 0 |
| Part 1 SAD: Cohort 5 | Part 1: Maximum Observed Plasma Concentration (Cmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7018822: Day 1 | 101 nanograms per milliliter (ng/mL) | Standard Deviation 37.7 |
| Part 1 SAD: Cohort 5 | Part 1: Maximum Observed Plasma Concentration (Cmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7033805: Day 1 | 0.00 nanograms per milliliter (ng/mL) | Standard Deviation 0 |
| Part 1 SAD: Cohort 6 | Part 1: Maximum Observed Plasma Concentration (Cmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7011785: Day 1 | 1830 nanograms per milliliter (ng/mL) | Standard Deviation 238 |
| Part 1 SAD: Cohort 6 | Part 1: Maximum Observed Plasma Concentration (Cmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7033805: Day 1 | 0.00 nanograms per milliliter (ng/mL) | Standard Deviation 0 |
| Part 1 SAD: Cohort 6 | Part 1: Maximum Observed Plasma Concentration (Cmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7020531: Day 1 | 0.00 nanograms per milliliter (ng/mL) | Standard Deviation 0 |
| Part 1 SAD: Cohort 6 | Part 1: Maximum Observed Plasma Concentration (Cmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7018822: Day 1 | 166 nanograms per milliliter (ng/mL) | Standard Deviation 79.3 |
| Part 1 SAD: Cohort 7 | Part 1: Maximum Observed Plasma Concentration (Cmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7018822: Day 1 | 189 nanograms per milliliter (ng/mL) | Standard Deviation 52.5 |
| Part 1 SAD: Cohort 7 | Part 1: Maximum Observed Plasma Concentration (Cmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7020531: Day 1 | 0.00 nanograms per milliliter (ng/mL) | Standard Deviation 0 |
| Part 1 SAD: Cohort 7 | Part 1: Maximum Observed Plasma Concentration (Cmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7011785: Day 1 | 1670 nanograms per milliliter (ng/mL) | Standard Deviation 654 |
| Part 1 SAD: Cohort 7 | Part 1: Maximum Observed Plasma Concentration (Cmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7033805: Day 1 | 0.285 nanograms per milliliter (ng/mL) | Standard Deviation 0.806 |
| Part 1 SAD: Cohort 8 | Part 1: Maximum Observed Plasma Concentration (Cmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7011785: Day 1 | 1060 nanograms per milliliter (ng/mL) | Standard Deviation 428 |
| Part 1 SAD: Cohort 8 | Part 1: Maximum Observed Plasma Concentration (Cmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7018822: Day 13 | 77.7 nanograms per milliliter (ng/mL) | Standard Deviation 42.2 |
| Part 1 SAD: Cohort 8 | Part 1: Maximum Observed Plasma Concentration (Cmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7011785: Day 13 | 1100 nanograms per milliliter (ng/mL) | Standard Deviation 448 |
| Part 1 SAD: Cohort 8 | Part 1: Maximum Observed Plasma Concentration (Cmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7018822: Day 1 | 98.3 nanograms per milliliter (ng/mL) | Standard Deviation 42.3 |
| Part 1 SAD: Cohort 8 | Part 1: Maximum Observed Plasma Concentration (Cmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7033805: Day 1 | 1.24 nanograms per milliliter (ng/mL) | — |
| Part 1 MAD: Cohort 2 | Part 1: Maximum Observed Plasma Concentration (Cmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7018822: Day 1 | 144 nanograms per milliliter (ng/mL) | Standard Deviation 52.1 |
| Part 1 MAD: Cohort 2 | Part 1: Maximum Observed Plasma Concentration (Cmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7018822: Day 13 | 125 nanograms per milliliter (ng/mL) | Standard Deviation 47.6 |
| Part 1 MAD: Cohort 2 | Part 1: Maximum Observed Plasma Concentration (Cmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7011785: Day 13 | 1470 nanograms per milliliter (ng/mL) | Standard Deviation 557 |
| Part 1 MAD: Cohort 2 | Part 1: Maximum Observed Plasma Concentration (Cmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7011785: Day 1 | 1680 nanograms per milliliter (ng/mL) | Standard Deviation 735 |
| Part 1 MAD: Cohort 3 | Part 1: Maximum Observed Plasma Concentration (Cmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7018822: Day 1 | 234 nanograms per milliliter (ng/mL) | Standard Deviation 163 |
| Part 1 MAD: Cohort 3 | Part 1: Maximum Observed Plasma Concentration (Cmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7011785: Day 13 | 2100 nanograms per milliliter (ng/mL) | Standard Deviation 838 |
| Part 1 MAD: Cohort 3 | Part 1: Maximum Observed Plasma Concentration (Cmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7020531: Day 1 | 1.87 nanograms per milliliter (ng/mL) | — |
| Part 1 MAD: Cohort 3 | Part 1: Maximum Observed Plasma Concentration (Cmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7033805: Day 13 | 1.90 nanograms per milliliter (ng/mL) | Standard Deviation 0.6 |
| Part 1 MAD: Cohort 3 | Part 1: Maximum Observed Plasma Concentration (Cmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7018822: Day 13 | 220 nanograms per milliliter (ng/mL) | Standard Deviation 143 |
| Part 1 MAD: Cohort 3 | Part 1: Maximum Observed Plasma Concentration (Cmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7033805: Day 1 | 2.30 nanograms per milliliter (ng/mL) | Standard Deviation 0.339 |
| Part 1 MAD: Cohort 3 | Part 1: Maximum Observed Plasma Concentration (Cmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7011785: Day 1 | 2150 nanograms per milliliter (ng/mL) | Standard Deviation 746 |
Secondary
Part 1:Mean Concentration of Interferon Alpha (IFN-alpha): SAD and MAD
Mean concentrations of IFN-alpha for SAD were calculated following single-dose and for MAD it was calculated following multiple doses. The standard deviation (SD) presented is actually the log transformed geometric standard deviation.
Time frame: SAD: Predose, 2, 6, 12 and 24 hrs Postdose; MAD: Predose, 2, 6, 12, and 24 hrs Postdose on Day 1; Predose, 2, 6 and 24 hrs Postdose on Days 3, 5, 7, 13 and 20
Population: Pharmacodynamic population included all HVs who had received at least 1 dose of the study drug and with PD data available.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1:Mean Concentration of Interferon Alpha (IFN-alpha): SAD and MAD | 0.0484 picogram per milliliter (pg/mL) | Standard Deviation 1.3166 |
| Part 1 SAD: Cohort 1 | Part 1:Mean Concentration of Interferon Alpha (IFN-alpha): SAD and MAD | 0.0475 picogram per milliliter (pg/mL) | Standard Deviation 1.4288 |
| Part 1 SAD: Cohort 2 | Part 1:Mean Concentration of Interferon Alpha (IFN-alpha): SAD and MAD | 0.0438 picogram per milliliter (pg/mL) | Standard Deviation 1.1316 |
| Part 1 SAD: Cohort 3 | Part 1:Mean Concentration of Interferon Alpha (IFN-alpha): SAD and MAD | 0.0447 picogram per milliliter (pg/mL) | Standard Deviation 1.1166 |
| Part 1 SAD: Cohort 4 | Part 1:Mean Concentration of Interferon Alpha (IFN-alpha): SAD and MAD | 0.0436 picogram per milliliter (pg/mL) | Standard Deviation 1.06 |
| Part 1 SAD: Cohort 5 | Part 1:Mean Concentration of Interferon Alpha (IFN-alpha): SAD and MAD | 0.0494 picogram per milliliter (pg/mL) | Standard Deviation 1.5718 |
| Part 1 SAD: Cohort 6 | Part 1:Mean Concentration of Interferon Alpha (IFN-alpha): SAD and MAD | 0.0533 picogram per milliliter (pg/mL) | Standard Deviation 1.5205 |
| Part 1 SAD: Cohort 7 | Part 1:Mean Concentration of Interferon Alpha (IFN-alpha): SAD and MAD | 0.1385 picogram per milliliter (pg/mL) | Standard Deviation 3.8417 |
| Part 1 SAD: Cohort 8 | Part 1:Mean Concentration of Interferon Alpha (IFN-alpha): SAD and MAD | 0.1358 picogram per milliliter (pg/mL) | Standard Deviation 3.8126 |
| Part 1 MAD: Cohort 2 | Part 1:Mean Concentration of Interferon Alpha (IFN-alpha): SAD and MAD | 0.0530 picogram per milliliter (pg/mL) | Standard Deviation 1.0135 |
| Part 1 MAD: Cohort 3 | Part 1:Mean Concentration of Interferon Alpha (IFN-alpha): SAD and MAD | 0.0761 picogram per milliliter (pg/mL) | Standard Deviation 1.9769 |
| Part 1 MAD: Cohort 2 | Part 1:Mean Concentration of Interferon Alpha (IFN-alpha): SAD and MAD | 0.1148 picogram per milliliter (pg/mL) | Standard Deviation 3.108 |
| Part 1 MAD: Cohort 3 | Part 1:Mean Concentration of Interferon Alpha (IFN-alpha): SAD and MAD | 0.3349 picogram per milliliter (pg/mL) | Standard Deviation 5.5985 |
Secondary
Part 1: Mean Fold Change From Baseline in Cytokine Markers: SAD and MAD
Cytokines markers include Chemokine (C-X-C Motif) Ligand 10 (IP-10), Interleukin 6 (IL-6), Interleukin 10 (IL-10), Interleukin 12 p40 (IL-12 p40), Neopterin, Tumor Necrosis Factor-Alpha (TNF-alpha). The SD presented is actually the log transformed geometric standard deviation.
Time frame: SAD: Predose, 2, 6, 12, 24, 48 (only Neopterin) and 96 hrs (only Neopterin) Postdose; MAD: Predose, 2, 6, 12, and 24 hrs Postdose on Day 1; Predose, 2, 6 and 24 hrs Postdose on Days 3, 5, 7, 13 and 20
Population: Pharmacodynamic population included all HVs who had received at least 1 dose of the study drug and with PD data available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Mean Fold Change From Baseline in Cytokine Markers: SAD and MAD | Neopterin | 0.9861 Fold change | Standard Deviation 1.1833 |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Mean Fold Change From Baseline in Cytokine Markers: SAD and MAD | IP-10 | 0.9067 Fold change | Standard Deviation 1.3101 |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Mean Fold Change From Baseline in Cytokine Markers: SAD and MAD | TNF-alpha | 1.0875 Fold change | Standard Deviation 1.8701 |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Mean Fold Change From Baseline in Cytokine Markers: SAD and MAD | IL-12 p40 | 1.0276 Fold change | Standard Deviation 1.2232 |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Mean Fold Change From Baseline in Cytokine Markers: SAD and MAD | IL-10 | 0.9692 Fold change | Standard Deviation 1.5013 |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Mean Fold Change From Baseline in Cytokine Markers: SAD and MAD | IL-6 | 1.4493 Fold change | Standard Deviation 2.4225 |
| Part 1 SAD: Cohort 1 | Part 1: Mean Fold Change From Baseline in Cytokine Markers: SAD and MAD | IL-12 p40 | 0.9414 Fold change | Standard Deviation 1.3431 |
| Part 1 SAD: Cohort 1 | Part 1: Mean Fold Change From Baseline in Cytokine Markers: SAD and MAD | TNF-alpha | 1.0374 Fold change | Standard Deviation 1.7561 |
| Part 1 SAD: Cohort 1 | Part 1: Mean Fold Change From Baseline in Cytokine Markers: SAD and MAD | Neopterin | 1.0561 Fold change | Standard Deviation 1.3678 |
| Part 1 SAD: Cohort 1 | Part 1: Mean Fold Change From Baseline in Cytokine Markers: SAD and MAD | IL-6 | 1.9626 Fold change | Standard Deviation 2.984 |
| Part 1 SAD: Cohort 1 | Part 1: Mean Fold Change From Baseline in Cytokine Markers: SAD and MAD | IP-10 | 0.8751 Fold change | Standard Deviation 1.4713 |
| Part 1 SAD: Cohort 1 | Part 1: Mean Fold Change From Baseline in Cytokine Markers: SAD and MAD | IL-10 | 0.7042 Fold change | Standard Deviation 2.097 |
| Part 1 SAD: Cohort 2 | Part 1: Mean Fold Change From Baseline in Cytokine Markers: SAD and MAD | TNF-alpha | 0.9435 Fold change | Standard Deviation 1.436 |
| Part 1 SAD: Cohort 2 | Part 1: Mean Fold Change From Baseline in Cytokine Markers: SAD and MAD | IP-10 | 0.9112 Fold change | Standard Deviation 1.3624 |
| Part 1 SAD: Cohort 2 | Part 1: Mean Fold Change From Baseline in Cytokine Markers: SAD and MAD | IL-10 | 1.0568 Fold change | Standard Deviation 1.5139 |
| Part 1 SAD: Cohort 2 | Part 1: Mean Fold Change From Baseline in Cytokine Markers: SAD and MAD | Neopterin | 1.0175 Fold change | Standard Deviation 1.2665 |
| Part 1 SAD: Cohort 2 | Part 1: Mean Fold Change From Baseline in Cytokine Markers: SAD and MAD | IL-6 | 1.2293 Fold change | Standard Deviation 1.9209 |
| Part 1 SAD: Cohort 2 | Part 1: Mean Fold Change From Baseline in Cytokine Markers: SAD and MAD | IL-12 p40 | 1.0419 Fold change | Standard Deviation 1.2198 |
| Part 1 SAD: Cohort 3 | Part 1: Mean Fold Change From Baseline in Cytokine Markers: SAD and MAD | IL-12 p40 | 0.9706 Fold change | Standard Deviation 1.0957 |
| Part 1 SAD: Cohort 3 | Part 1: Mean Fold Change From Baseline in Cytokine Markers: SAD and MAD | TNF-alpha | 0.8698 Fold change | Standard Deviation 2.1721 |
| Part 1 SAD: Cohort 3 | Part 1: Mean Fold Change From Baseline in Cytokine Markers: SAD and MAD | IP-10 | 0.9250 Fold change | Standard Deviation 1.2966 |
| Part 1 SAD: Cohort 3 | Part 1: Mean Fold Change From Baseline in Cytokine Markers: SAD and MAD | IL-10 | 0.9622 Fold change | Standard Deviation 1.3461 |
| Part 1 SAD: Cohort 3 | Part 1: Mean Fold Change From Baseline in Cytokine Markers: SAD and MAD | Neopterin | 0.9878 Fold change | Standard Deviation 1.23 |
| Part 1 SAD: Cohort 3 | Part 1: Mean Fold Change From Baseline in Cytokine Markers: SAD and MAD | IL-6 | 1.2464 Fold change | Standard Deviation 2.5694 |
| Part 1 SAD: Cohort 4 | Part 1: Mean Fold Change From Baseline in Cytokine Markers: SAD and MAD | Neopterin | 0.9975 Fold change | Standard Deviation 1.1503 |
| Part 1 SAD: Cohort 4 | Part 1: Mean Fold Change From Baseline in Cytokine Markers: SAD and MAD | TNF-alpha | 1.0781 Fold change | Standard Deviation 1.4358 |
| Part 1 SAD: Cohort 4 | Part 1: Mean Fold Change From Baseline in Cytokine Markers: SAD and MAD | IL-6 | 1.2857 Fold change | Standard Deviation 1.8437 |
| Part 1 SAD: Cohort 4 | Part 1: Mean Fold Change From Baseline in Cytokine Markers: SAD and MAD | IL-10 | 0.9483 Fold change | Standard Deviation 1.4871 |
| Part 1 SAD: Cohort 4 | Part 1: Mean Fold Change From Baseline in Cytokine Markers: SAD and MAD | IL-12 p40 | 1.0000 Fold change | Standard Deviation 1 |
| Part 1 SAD: Cohort 4 | Part 1: Mean Fold Change From Baseline in Cytokine Markers: SAD and MAD | IP-10 | 0.9754 Fold change | Standard Deviation 1.2328 |
| Part 1 SAD: Cohort 5 | Part 1: Mean Fold Change From Baseline in Cytokine Markers: SAD and MAD | IL-10 | 0.7451 Fold change | Standard Deviation 2.3095 |
| Part 1 SAD: Cohort 5 | Part 1: Mean Fold Change From Baseline in Cytokine Markers: SAD and MAD | Neopterin | 0.9896 Fold change | Standard Deviation 1.2475 |
| Part 1 SAD: Cohort 5 | Part 1: Mean Fold Change From Baseline in Cytokine Markers: SAD and MAD | TNF-alpha | 0.8825 Fold change | Standard Deviation 1.7991 |
| Part 1 SAD: Cohort 5 | Part 1: Mean Fold Change From Baseline in Cytokine Markers: SAD and MAD | IP-10 | 0.9267 Fold change | Standard Deviation 1.2754 |
| Part 1 SAD: Cohort 5 | Part 1: Mean Fold Change From Baseline in Cytokine Markers: SAD and MAD | IL-6 | 0.9486 Fold change | Standard Deviation 1.9942 |
| Part 1 SAD: Cohort 5 | Part 1: Mean Fold Change From Baseline in Cytokine Markers: SAD and MAD | IL-12 p40 | 1.0012 Fold change | Standard Deviation 1.0156 |
| Part 1 SAD: Cohort 6 | Part 1: Mean Fold Change From Baseline in Cytokine Markers: SAD and MAD | IL-12 p40 | 1.0000 Fold change | Standard Deviation 1 |
| Part 1 SAD: Cohort 6 | Part 1: Mean Fold Change From Baseline in Cytokine Markers: SAD and MAD | Neopterin | 0.9738 Fold change | Standard Deviation 1.1791 |
| Part 1 SAD: Cohort 6 | Part 1: Mean Fold Change From Baseline in Cytokine Markers: SAD and MAD | IL-6 | 1.3207 Fold change | Standard Deviation 2.096 |
| Part 1 SAD: Cohort 6 | Part 1: Mean Fold Change From Baseline in Cytokine Markers: SAD and MAD | TNF-alpha | 0.9249 Fold change | Standard Deviation 1.653 |
| Part 1 SAD: Cohort 6 | Part 1: Mean Fold Change From Baseline in Cytokine Markers: SAD and MAD | IL-10 | 1.0047 Fold change | Standard Deviation 1.3322 |
| Part 1 SAD: Cohort 6 | Part 1: Mean Fold Change From Baseline in Cytokine Markers: SAD and MAD | IP-10 | 1.0390 Fold change | Standard Deviation 1.2198 |
| Part 1 SAD: Cohort 7 | Part 1: Mean Fold Change From Baseline in Cytokine Markers: SAD and MAD | TNF-alpha | 0.9663 Fold change | Standard Deviation 1.7846 |
| Part 1 SAD: Cohort 7 | Part 1: Mean Fold Change From Baseline in Cytokine Markers: SAD and MAD | IL-12 p40 | 1.0025 Fold change | Standard Deviation 1.1817 |
| Part 1 SAD: Cohort 7 | Part 1: Mean Fold Change From Baseline in Cytokine Markers: SAD and MAD | IL-10 | 1.1900 Fold change | Standard Deviation 1.6328 |
| Part 1 SAD: Cohort 7 | Part 1: Mean Fold Change From Baseline in Cytokine Markers: SAD and MAD | IL-6 | 1.4167 Fold change | Standard Deviation 2.3111 |
| Part 1 SAD: Cohort 7 | Part 1: Mean Fold Change From Baseline in Cytokine Markers: SAD and MAD | Neopterin | 1.0688 Fold change | Standard Deviation 1.3926 |
| Part 1 SAD: Cohort 7 | Part 1: Mean Fold Change From Baseline in Cytokine Markers: SAD and MAD | IP-10 | 1.6532 Fold change | Standard Deviation 2.0266 |
| Part 1 SAD: Cohort 8 | Part 1: Mean Fold Change From Baseline in Cytokine Markers: SAD and MAD | Neopterin | 1.1257 Fold change | Standard Deviation 1.4298 |
| Part 1 SAD: Cohort 8 | Part 1: Mean Fold Change From Baseline in Cytokine Markers: SAD and MAD | IP-10 | 1.2909 Fold change | Standard Deviation 1.8003 |
| Part 1 SAD: Cohort 8 | Part 1: Mean Fold Change From Baseline in Cytokine Markers: SAD and MAD | IL-6 | 1.6928 Fold change | Standard Deviation 2.1981 |
| Part 1 SAD: Cohort 8 | Part 1: Mean Fold Change From Baseline in Cytokine Markers: SAD and MAD | TNF-alpha | 1.1756 Fold change | Standard Deviation 1.5505 |
| Part 1 SAD: Cohort 8 | Part 1: Mean Fold Change From Baseline in Cytokine Markers: SAD and MAD | IL-12 p40 | 1.0009 Fold change | Standard Deviation 1.0049 |
| Part 1 SAD: Cohort 8 | Part 1: Mean Fold Change From Baseline in Cytokine Markers: SAD and MAD | IL-10 | 1.1926 Fold change | Standard Deviation 1.4208 |
| Part 1 MAD: Cohort 2 | Part 1: Mean Fold Change From Baseline in Cytokine Markers: SAD and MAD | IL-12 p40 | 0.6782 Fold change | Standard Deviation 1.7025 |
| Part 1 MAD: Cohort 2 | Part 1: Mean Fold Change From Baseline in Cytokine Markers: SAD and MAD | IP-10 | 1.0256 Fold change | Standard Deviation 1.4853 |
| Part 1 MAD: Cohort 2 | Part 1: Mean Fold Change From Baseline in Cytokine Markers: SAD and MAD | Neopterin | 0.9331 Fold change | Standard Deviation 1.1446 |
| Part 1 MAD: Cohort 2 | Part 1: Mean Fold Change From Baseline in Cytokine Markers: SAD and MAD | IL-10 | 0.6841 Fold change | Standard Deviation 3.4286 |
| Part 1 MAD: Cohort 2 | Part 1: Mean Fold Change From Baseline in Cytokine Markers: SAD and MAD | IL-6 | 1.8290 Fold change | Standard Deviation 2.8323 |
| Part 1 MAD: Cohort 2 | Part 1: Mean Fold Change From Baseline in Cytokine Markers: SAD and MAD | TNF-alpha | 1.0830 Fold change | Standard Deviation 1.6154 |
| Part 1 MAD: Cohort 3 | Part 1: Mean Fold Change From Baseline in Cytokine Markers: SAD and MAD | TNF-alpha | 1.2136 Fold change | Standard Deviation 1.5828 |
| Part 1 MAD: Cohort 3 | Part 1: Mean Fold Change From Baseline in Cytokine Markers: SAD and MAD | IL-12 p40 | 0.8672 Fold change | Standard Deviation 1.3474 |
| Part 1 MAD: Cohort 3 | Part 1: Mean Fold Change From Baseline in Cytokine Markers: SAD and MAD | IL-6 | 1.3521 Fold change | Standard Deviation 2.2473 |
| Part 1 MAD: Cohort 3 | Part 1: Mean Fold Change From Baseline in Cytokine Markers: SAD and MAD | IP-10 | 1.2010 Fold change | Standard Deviation 1.4186 |
| Part 1 MAD: Cohort 3 | Part 1: Mean Fold Change From Baseline in Cytokine Markers: SAD and MAD | IL-10 | 1.0961 Fold change | Standard Deviation 1.456 |
| Part 1 MAD: Cohort 3 | Part 1: Mean Fold Change From Baseline in Cytokine Markers: SAD and MAD | Neopterin | 1.5842 Fold change | Standard Deviation 1.3637 |
| Part 1 MAD: Cohort 2 | Part 1: Mean Fold Change From Baseline in Cytokine Markers: SAD and MAD | IL-6 | 1.9065 Fold change | Standard Deviation 2.2325 |
| Part 1 MAD: Cohort 2 | Part 1: Mean Fold Change From Baseline in Cytokine Markers: SAD and MAD | TNF-alpha | 0.9887 Fold change | Standard Deviation 1.5106 |
| Part 1 MAD: Cohort 2 | Part 1: Mean Fold Change From Baseline in Cytokine Markers: SAD and MAD | IL-10 | 0.8834 Fold change | Standard Deviation 1.5662 |
| Part 1 MAD: Cohort 2 | Part 1: Mean Fold Change From Baseline in Cytokine Markers: SAD and MAD | Neopterin | 1.1228 Fold change | Standard Deviation 1.526 |
| Part 1 MAD: Cohort 2 | Part 1: Mean Fold Change From Baseline in Cytokine Markers: SAD and MAD | IL-12 p40 | 0.9588 Fold change | Standard Deviation 1.347 |
| Part 1 MAD: Cohort 2 | Part 1: Mean Fold Change From Baseline in Cytokine Markers: SAD and MAD | IP-10 | 1.2076 Fold change | Standard Deviation 1.7543 |
| Part 1 MAD: Cohort 3 | Part 1: Mean Fold Change From Baseline in Cytokine Markers: SAD and MAD | Neopterin | 1.5453 Fold change | Standard Deviation 1.5431 |
| Part 1 MAD: Cohort 3 | Part 1: Mean Fold Change From Baseline in Cytokine Markers: SAD and MAD | IP-10 | 1.7327 Fold change | Standard Deviation 2.3938 |
| Part 1 MAD: Cohort 3 | Part 1: Mean Fold Change From Baseline in Cytokine Markers: SAD and MAD | IL-10 | 1.1232 Fold change | Standard Deviation 1.5901 |
| Part 1 MAD: Cohort 3 | Part 1: Mean Fold Change From Baseline in Cytokine Markers: SAD and MAD | TNF-alpha | 0.8985 Fold change | Standard Deviation 1.6625 |
| Part 1 MAD: Cohort 3 | Part 1: Mean Fold Change From Baseline in Cytokine Markers: SAD and MAD | IL-6 | 1.1306 Fold change | Standard Deviation 2.3792 |
| Part 1 MAD: Cohort 3 | Part 1: Mean Fold Change From Baseline in Cytokine Markers: SAD and MAD | IL-12 p40 | 0.9002 Fold change | Standard Deviation 1.3373 |
Secondary
Part 1:Mean Fold Change From Baseline in Markers of Transcriptional Responses: SAD and MAD
Markers of transcriptional responses includes messenger ribonucleic acid interferon-stimulated gene 15(mRNA ISG15), messenger RNA oligoadenylate synthetase 1 (mRNA OAS1), messenger RNA myxovirus resistance 1 gene (mRNA MX-1), messenger RNA Toll-like receptor (mRNA TLR7). The SD presented is actually the log transformed geometric standard deviation.
Time frame: SAD: Predose, 2, 6, 12 and 24 Postdose; MAD: Predose, 2, 6, 12, and 24 hrs Postdose on Day 1; Predose, 2, 6 and 24 hrs Postdose on Days 3, 5, 7, 13 and 20
Population: Pharmacodynamic population included all HVs who had received at least 1 dose of the study drug and with PD data available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1:Mean Fold Change From Baseline in Markers of Transcriptional Responses: SAD and MAD | mRNA Mx-1 | 1.0179 Fold change | Standard Deviation 1.3078 |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1:Mean Fold Change From Baseline in Markers of Transcriptional Responses: SAD and MAD | mRNA OAS1 | 1.0251 Fold change | Standard Deviation 1.2295 |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1:Mean Fold Change From Baseline in Markers of Transcriptional Responses: SAD and MAD | mRNA ISG15 | 0.9709 Fold change | Standard Deviation 1.2752 |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1:Mean Fold Change From Baseline in Markers of Transcriptional Responses: SAD and MAD | mRNA TLR7 | 1.0698 Fold change | Standard Deviation 1.3124 |
| Part 1 SAD: Cohort 1 | Part 1:Mean Fold Change From Baseline in Markers of Transcriptional Responses: SAD and MAD | mRNA OAS1 | 1.0414 Fold change | Standard Deviation 1.4571 |
| Part 1 SAD: Cohort 1 | Part 1:Mean Fold Change From Baseline in Markers of Transcriptional Responses: SAD and MAD | mRNA Mx-1 | 0.9750 Fold change | Standard Deviation 1.5209 |
| Part 1 SAD: Cohort 1 | Part 1:Mean Fold Change From Baseline in Markers of Transcriptional Responses: SAD and MAD | mRNA TLR7 | 1.1518 Fold change | Standard Deviation 1.3697 |
| Part 1 SAD: Cohort 1 | Part 1:Mean Fold Change From Baseline in Markers of Transcriptional Responses: SAD and MAD | mRNA ISG15 | 1.1708 Fold change | Standard Deviation 1.9326 |
| Part 1 SAD: Cohort 2 | Part 1:Mean Fold Change From Baseline in Markers of Transcriptional Responses: SAD and MAD | mRNA Mx-1 | 1.0166 Fold change | Standard Deviation 1.4143 |
| Part 1 SAD: Cohort 2 | Part 1:Mean Fold Change From Baseline in Markers of Transcriptional Responses: SAD and MAD | mRNA TLR7 | 1.0401 Fold change | Standard Deviation 1.2667 |
| Part 1 SAD: Cohort 2 | Part 1:Mean Fold Change From Baseline in Markers of Transcriptional Responses: SAD and MAD | mRNA OAS1 | 1.0338 Fold change | Standard Deviation 1.2876 |
| Part 1 SAD: Cohort 2 | Part 1:Mean Fold Change From Baseline in Markers of Transcriptional Responses: SAD and MAD | mRNA ISG15 | 1.0525 Fold change | Standard Deviation 1.3985 |
| Part 1 SAD: Cohort 3 | Part 1:Mean Fold Change From Baseline in Markers of Transcriptional Responses: SAD and MAD | mRNA TLR7 | 1.0658 Fold change | Standard Deviation 1.2237 |
| Part 1 SAD: Cohort 3 | Part 1:Mean Fold Change From Baseline in Markers of Transcriptional Responses: SAD and MAD | mRNA Mx-1 | 0.9045 Fold change | Standard Deviation 1.4844 |
| Part 1 SAD: Cohort 3 | Part 1:Mean Fold Change From Baseline in Markers of Transcriptional Responses: SAD and MAD | mRNA OAS1 | 0.9666 Fold change | Standard Deviation 1.406 |
| Part 1 SAD: Cohort 3 | Part 1:Mean Fold Change From Baseline in Markers of Transcriptional Responses: SAD and MAD | mRNA ISG15 | 0.9386 Fold change | Standard Deviation 1.5924 |
| Part 1 SAD: Cohort 4 | Part 1:Mean Fold Change From Baseline in Markers of Transcriptional Responses: SAD and MAD | mRNA OAS1 | 0.8584 Fold change | Standard Deviation 1.7499 |
| Part 1 SAD: Cohort 4 | Part 1:Mean Fold Change From Baseline in Markers of Transcriptional Responses: SAD and MAD | mRNA ISG15 | 1.0799 Fold change | Standard Deviation 1.398 |
| Part 1 SAD: Cohort 4 | Part 1:Mean Fold Change From Baseline in Markers of Transcriptional Responses: SAD and MAD | mRNA TLR7 | 1.0965 Fold change | Standard Deviation 1.3698 |
| Part 1 SAD: Cohort 4 | Part 1:Mean Fold Change From Baseline in Markers of Transcriptional Responses: SAD and MAD | mRNA Mx-1 | 0.8811 Fold change | Standard Deviation 1.5884 |
| Part 1 SAD: Cohort 5 | Part 1:Mean Fold Change From Baseline in Markers of Transcriptional Responses: SAD and MAD | mRNA ISG15 | 1.0190 Fold change | Standard Deviation 1.6295 |
| Part 1 SAD: Cohort 5 | Part 1:Mean Fold Change From Baseline in Markers of Transcriptional Responses: SAD and MAD | mRNA Mx-1 | 1.0837 Fold change | Standard Deviation 1.6314 |
| Part 1 SAD: Cohort 5 | Part 1:Mean Fold Change From Baseline in Markers of Transcriptional Responses: SAD and MAD | mRNA OAS1 | 1.0680 Fold change | Standard Deviation 1.4851 |
| Part 1 SAD: Cohort 5 | Part 1:Mean Fold Change From Baseline in Markers of Transcriptional Responses: SAD and MAD | mRNA TLR7 | 1.1289 Fold change | Standard Deviation 1.271 |
| Part 1 SAD: Cohort 6 | Part 1:Mean Fold Change From Baseline in Markers of Transcriptional Responses: SAD and MAD | mRNA TLR7 | 1.2120 Fold change | Standard Deviation 1.3328 |
| Part 1 SAD: Cohort 6 | Part 1:Mean Fold Change From Baseline in Markers of Transcriptional Responses: SAD and MAD | mRNA ISG15 | 1.6951 Fold change | Standard Deviation 2.5735 |
| Part 1 SAD: Cohort 6 | Part 1:Mean Fold Change From Baseline in Markers of Transcriptional Responses: SAD and MAD | mRNA OAS1 | 1.4093 Fold change | Standard Deviation 1.7808 |
| Part 1 SAD: Cohort 6 | Part 1:Mean Fold Change From Baseline in Markers of Transcriptional Responses: SAD and MAD | mRNA Mx-1 | 1.5271 Fold change | Standard Deviation 2.307 |
| Part 1 SAD: Cohort 7 | Part 1:Mean Fold Change From Baseline in Markers of Transcriptional Responses: SAD and MAD | mRNA OAS1 | 2.3437 Fold change | Standard Deviation 2.5254 |
| Part 1 SAD: Cohort 7 | Part 1:Mean Fold Change From Baseline in Markers of Transcriptional Responses: SAD and MAD | mRNA ISG15 | 3.0359 Fold change | Standard Deviation 4.0456 |
| Part 1 SAD: Cohort 7 | Part 1:Mean Fold Change From Baseline in Markers of Transcriptional Responses: SAD and MAD | mRNA Mx-1 | 2.8672 Fold change | Standard Deviation 3.517 |
| Part 1 SAD: Cohort 7 | Part 1:Mean Fold Change From Baseline in Markers of Transcriptional Responses: SAD and MAD | mRNA TLR7 | 1.5925 Fold change | Standard Deviation 1.6473 |
| Part 1 SAD: Cohort 8 | Part 1:Mean Fold Change From Baseline in Markers of Transcriptional Responses: SAD and MAD | mRNA OAS1 | 2.2308 Fold change | Standard Deviation 2.4993 |
| Part 1 SAD: Cohort 8 | Part 1:Mean Fold Change From Baseline in Markers of Transcriptional Responses: SAD and MAD | mRNA Mx-1 | 2.6646 Fold change | Standard Deviation 3.0944 |
| Part 1 SAD: Cohort 8 | Part 1:Mean Fold Change From Baseline in Markers of Transcriptional Responses: SAD and MAD | mRNA TLR7 | 1.5596 Fold change | Standard Deviation 2.1403 |
| Part 1 SAD: Cohort 8 | Part 1:Mean Fold Change From Baseline in Markers of Transcriptional Responses: SAD and MAD | mRNA ISG15 | 3.1083 Fold change | Standard Deviation 3.9014 |
| Part 1 MAD: Cohort 2 | Part 1:Mean Fold Change From Baseline in Markers of Transcriptional Responses: SAD and MAD | mRNA TLR7 | 1.2315 Fold change | Standard Deviation 1.6428 |
| Part 1 MAD: Cohort 2 | Part 1:Mean Fold Change From Baseline in Markers of Transcriptional Responses: SAD and MAD | mRNA ISG15 | 1.1703 Fold change | Standard Deviation 1.6841 |
| Part 1 MAD: Cohort 2 | Part 1:Mean Fold Change From Baseline in Markers of Transcriptional Responses: SAD and MAD | mRNA OAS1 | 1.0651 Fold change | Standard Deviation 1.5253 |
| Part 1 MAD: Cohort 2 | Part 1:Mean Fold Change From Baseline in Markers of Transcriptional Responses: SAD and MAD | mRNA Mx-1 | 0.9813 Fold change | Standard Deviation 1.5661 |
| Part 1 MAD: Cohort 3 | Part 1:Mean Fold Change From Baseline in Markers of Transcriptional Responses: SAD and MAD | mRNA ISG15 | 1.9408 Fold change | Standard Deviation 2.6372 |
| Part 1 MAD: Cohort 3 | Part 1:Mean Fold Change From Baseline in Markers of Transcriptional Responses: SAD and MAD | mRNA TLR7 | 1.2089 Fold change | Standard Deviation 1.6716 |
| Part 1 MAD: Cohort 3 | Part 1:Mean Fold Change From Baseline in Markers of Transcriptional Responses: SAD and MAD | mRNA Mx-1 | 2.3613 Fold change | Standard Deviation 2.8339 |
| Part 1 MAD: Cohort 3 | Part 1:Mean Fold Change From Baseline in Markers of Transcriptional Responses: SAD and MAD | mRNA OAS1 | 1.8186 Fold change | Standard Deviation 2.3871 |
| Part 1 MAD: Cohort 2 | Part 1:Mean Fold Change From Baseline in Markers of Transcriptional Responses: SAD and MAD | mRNA ISG15 | 2.3632 Fold change | Standard Deviation 2.8453 |
| Part 1 MAD: Cohort 2 | Part 1:Mean Fold Change From Baseline in Markers of Transcriptional Responses: SAD and MAD | mRNA Mx-1 | 2.0847 Fold change | Standard Deviation 2.8118 |
| Part 1 MAD: Cohort 2 | Part 1:Mean Fold Change From Baseline in Markers of Transcriptional Responses: SAD and MAD | mRNA TLR7 | 1.2626 Fold change | Standard Deviation 1.5696 |
| Part 1 MAD: Cohort 2 | Part 1:Mean Fold Change From Baseline in Markers of Transcriptional Responses: SAD and MAD | mRNA OAS1 | 2.1467 Fold change | Standard Deviation 2.261 |
| Part 1 MAD: Cohort 3 | Part 1:Mean Fold Change From Baseline in Markers of Transcriptional Responses: SAD and MAD | mRNA Mx-1 | 3.2388 Fold change | Standard Deviation 3.9277 |
| Part 1 MAD: Cohort 3 | Part 1:Mean Fold Change From Baseline in Markers of Transcriptional Responses: SAD and MAD | mRNA TLR7 | 1.6081 Fold change | Standard Deviation 1.8082 |
| Part 1 MAD: Cohort 3 | Part 1:Mean Fold Change From Baseline in Markers of Transcriptional Responses: SAD and MAD | mRNA ISG15 | 4.8748 Fold change | Standard Deviation 4.1091 |
| Part 1 MAD: Cohort 3 | Part 1:Mean Fold Change From Baseline in Markers of Transcriptional Responses: SAD and MAD | mRNA OAS1 | 3.2312 Fold change | Standard Deviation 3.0239 |
Secondary
Part 1: Time to Maximum Observed Plasma Concentration (Tmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD
Time frame: SAD: Predose and 0.5, 1, 1.5 , 2, 3, 4, 6,8, 12,18, and 24hours post dose on Day 1; MAD: Predose and 0.25, 0.5, 1, 1.5, 2 , 3, 4, 6, 8, 12,18, and 24 hours post dose on Days 1 and 13
Population: The PK analysis population included all HVs randomized and adherent to the protocol. Number analyzed is the number of participants available at the specific timepoints.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Time to Maximum Observed Plasma Concentration (Tmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7011785: Day 1 | 0.75 hours (hr) |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Time to Maximum Observed Plasma Concentration (Tmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7020531: Day 1 | 0.00 hours (hr) |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Time to Maximum Observed Plasma Concentration (Tmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7033805: Day 1 | 0.00 hours (hr) |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Time to Maximum Observed Plasma Concentration (Tmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7018822: Day 1 | 0.50 hours (hr) |
| Part 1 SAD: Cohort 1 | Part 1: Time to Maximum Observed Plasma Concentration (Tmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7020531: Day 1 | 0.00 hours (hr) |
| Part 1 SAD: Cohort 1 | Part 1: Time to Maximum Observed Plasma Concentration (Tmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7018822: Day 1 | 0.50 hours (hr) |
| Part 1 SAD: Cohort 1 | Part 1: Time to Maximum Observed Plasma Concentration (Tmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7011785: Day 1 | 0.51 hours (hr) |
| Part 1 SAD: Cohort 1 | Part 1: Time to Maximum Observed Plasma Concentration (Tmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7033805: Day 1 | 0.00 hours (hr) |
| Part 1 SAD: Cohort 2 | Part 1: Time to Maximum Observed Plasma Concentration (Tmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7033805: Day 1 | 0.00 hours (hr) |
| Part 1 SAD: Cohort 2 | Part 1: Time to Maximum Observed Plasma Concentration (Tmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7018822: Day 1 | 0.50 hours (hr) |
| Part 1 SAD: Cohort 2 | Part 1: Time to Maximum Observed Plasma Concentration (Tmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7011785: Day 1 | 1.00 hours (hr) |
| Part 1 SAD: Cohort 2 | Part 1: Time to Maximum Observed Plasma Concentration (Tmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7020531: Day 1 | 0.00 hours (hr) |
| Part 1 SAD: Cohort 3 | Part 1: Time to Maximum Observed Plasma Concentration (Tmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7011785: Day 1 | 0.78 hours (hr) |
| Part 1 SAD: Cohort 3 | Part 1: Time to Maximum Observed Plasma Concentration (Tmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7033805: Day 1 | 0.00 hours (hr) |
| Part 1 SAD: Cohort 3 | Part 1: Time to Maximum Observed Plasma Concentration (Tmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7020531: Day 1 | 0.00 hours (hr) |
| Part 1 SAD: Cohort 3 | Part 1: Time to Maximum Observed Plasma Concentration (Tmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7018822: Day 1 | 0.50 hours (hr) |
| Part 1 SAD: Cohort 4 | Part 1: Time to Maximum Observed Plasma Concentration (Tmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7033805: Day 1 | 0.00 hours (hr) |
| Part 1 SAD: Cohort 4 | Part 1: Time to Maximum Observed Plasma Concentration (Tmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7011785: Day 1 | 0.75 hours (hr) |
| Part 1 SAD: Cohort 4 | Part 1: Time to Maximum Observed Plasma Concentration (Tmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7018822: Day 1 | 0.50 hours (hr) |
| Part 1 SAD: Cohort 4 | Part 1: Time to Maximum Observed Plasma Concentration (Tmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7020531: Day 1 | 0.00 hours (hr) |
| Part 1 SAD: Cohort 5 | Part 1: Time to Maximum Observed Plasma Concentration (Tmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7011785: Day 1 | 1.00 hours (hr) |
| Part 1 SAD: Cohort 5 | Part 1: Time to Maximum Observed Plasma Concentration (Tmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7020531: Day 1 | 0.00 hours (hr) |
| Part 1 SAD: Cohort 5 | Part 1: Time to Maximum Observed Plasma Concentration (Tmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7018822: Day 1 | 1.00 hours (hr) |
| Part 1 SAD: Cohort 5 | Part 1: Time to Maximum Observed Plasma Concentration (Tmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7033805: Day 1 | 0.00 hours (hr) |
| Part 1 SAD: Cohort 6 | Part 1: Time to Maximum Observed Plasma Concentration (Tmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7011785: Day 1 | 1.00 hours (hr) |
| Part 1 SAD: Cohort 6 | Part 1: Time to Maximum Observed Plasma Concentration (Tmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7033805: Day 1 | 0.00 hours (hr) |
| Part 1 SAD: Cohort 6 | Part 1: Time to Maximum Observed Plasma Concentration (Tmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7020531: Day 1 | 0.00 hours (hr) |
| Part 1 SAD: Cohort 6 | Part 1: Time to Maximum Observed Plasma Concentration (Tmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7018822: Day 1 | 0.75 hours (hr) |
| Part 1 SAD: Cohort 7 | Part 1: Time to Maximum Observed Plasma Concentration (Tmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7018822: Day 1 | 0.77 hours (hr) |
| Part 1 SAD: Cohort 7 | Part 1: Time to Maximum Observed Plasma Concentration (Tmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7020531: Day 1 | 0.00 hours (hr) |
| Part 1 SAD: Cohort 7 | Part 1: Time to Maximum Observed Plasma Concentration (Tmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7011785: Day 1 | 0.52 hours (hr) |
| Part 1 SAD: Cohort 7 | Part 1: Time to Maximum Observed Plasma Concentration (Tmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7033805: Day 1 | 0.00 hours (hr) |
| Part 1 SAD: Cohort 8 | Part 1: Time to Maximum Observed Plasma Concentration (Tmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7011785: Day 1 | 1.00 hours (hr) |
| Part 1 SAD: Cohort 8 | Part 1: Time to Maximum Observed Plasma Concentration (Tmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7018822: Day 13 | 1.00 hours (hr) |
| Part 1 SAD: Cohort 8 | Part 1: Time to Maximum Observed Plasma Concentration (Tmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7011785: Day 13 | 1.00 hours (hr) |
| Part 1 SAD: Cohort 8 | Part 1: Time to Maximum Observed Plasma Concentration (Tmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7018822: Day 1 | 0.75 hours (hr) |
| Part 1 SAD: Cohort 8 | Part 1: Time to Maximum Observed Plasma Concentration (Tmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7033805: Day 1 | 0.50 hours (hr) |
| Part 1 MAD: Cohort 2 | Part 1: Time to Maximum Observed Plasma Concentration (Tmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7018822: Day 1 | 1.00 hours (hr) |
| Part 1 MAD: Cohort 2 | Part 1: Time to Maximum Observed Plasma Concentration (Tmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7018822: Day 13 | 0.73 hours (hr) |
| Part 1 MAD: Cohort 2 | Part 1: Time to Maximum Observed Plasma Concentration (Tmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7011785: Day 13 | 1.00 hours (hr) |
| Part 1 MAD: Cohort 2 | Part 1: Time to Maximum Observed Plasma Concentration (Tmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7011785: Day 1 | 1.00 hours (hr) |
| Part 1 MAD: Cohort 3 | Part 1: Time to Maximum Observed Plasma Concentration (Tmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7018822: Day 1 | 0.52 hours (hr) |
| Part 1 MAD: Cohort 3 | Part 1: Time to Maximum Observed Plasma Concentration (Tmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7011785: Day 13 | 0.50 hours (hr) |
| Part 1 MAD: Cohort 3 | Part 1: Time to Maximum Observed Plasma Concentration (Tmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7020531: Day 1 | 0.25 hours (hr) |
| Part 1 MAD: Cohort 3 | Part 1: Time to Maximum Observed Plasma Concentration (Tmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7033805: Day 13 | 0.50 hours (hr) |
| Part 1 MAD: Cohort 3 | Part 1: Time to Maximum Observed Plasma Concentration (Tmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7018822: Day 13 | 0.50 hours (hr) |
| Part 1 MAD: Cohort 3 | Part 1: Time to Maximum Observed Plasma Concentration (Tmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7033805: Day 1 | 0.51 hours (hr) |
| Part 1 MAD: Cohort 3 | Part 1: Time to Maximum Observed Plasma Concentration (Tmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD | RO7011785: Day 1 | 0.76 hours (hr) |
Secondary
Part 1: Total Amount of RO7020531, RO7011785, RO7018822 and RO7033805 in Urine: SAD
Total amount of the study drug and metabolites recovered in urine was reported.
Time frame: 0 to 24 hrs Postdose on Day 1
Population: The PK analysis population included all HVs randomized and adherent to the protocol. Number analyzed is the number of participants available at the specific timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Total Amount of RO7020531, RO7011785, RO7018822 and RO7033805 in Urine: SAD | RO7020531 | 0.00 mg | Standard Deviation 0 |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Total Amount of RO7020531, RO7011785, RO7018822 and RO7033805 in Urine: SAD | RO7033805 | 0.00 mg | Standard Deviation 0 |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Total Amount of RO7020531, RO7011785, RO7018822 and RO7033805 in Urine: SAD | RO7018822 | 0.0137 mg | Standard Deviation 0.0167 |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 1: Total Amount of RO7020531, RO7011785, RO7018822 and RO7033805 in Urine: SAD | RO7011785 | 1.70 mg | Standard Deviation 0.274 |
| Part 1 SAD: Cohort 1 | Part 1: Total Amount of RO7020531, RO7011785, RO7018822 and RO7033805 in Urine: SAD | RO7033805 | 0.00 mg | Standard Deviation 0 |
| Part 1 SAD: Cohort 1 | Part 1: Total Amount of RO7020531, RO7011785, RO7018822 and RO7033805 in Urine: SAD | RO7011785 | 5.04 mg | Standard Deviation 1.23 |
| Part 1 SAD: Cohort 1 | Part 1: Total Amount of RO7020531, RO7011785, RO7018822 and RO7033805 in Urine: SAD | RO7020531 | 0.00 mg | Standard Deviation 0 |
| Part 1 SAD: Cohort 1 | Part 1: Total Amount of RO7020531, RO7011785, RO7018822 and RO7033805 in Urine: SAD | RO7018822 | 0.0754 mg | Standard Deviation 0.0274 |
| Part 1 SAD: Cohort 2 | Part 1: Total Amount of RO7020531, RO7011785, RO7018822 and RO7033805 in Urine: SAD | RO7018822 | 0.188 mg | Standard Deviation 0.0399 |
| Part 1 SAD: Cohort 2 | Part 1: Total Amount of RO7020531, RO7011785, RO7018822 and RO7033805 in Urine: SAD | RO7033805 | 0.00 mg | Standard Deviation 0 |
| Part 1 SAD: Cohort 2 | Part 1: Total Amount of RO7020531, RO7011785, RO7018822 and RO7033805 in Urine: SAD | RO7011785 | 11.0 mg | Standard Deviation 1.92 |
| Part 1 SAD: Cohort 2 | Part 1: Total Amount of RO7020531, RO7011785, RO7018822 and RO7033805 in Urine: SAD | RO7020531 | 0.00 mg | Standard Deviation 0 |
| Part 1 SAD: Cohort 3 | Part 1: Total Amount of RO7020531, RO7011785, RO7018822 and RO7033805 in Urine: SAD | RO7020531 | 0.00 mg | Standard Deviation 0 |
| Part 1 SAD: Cohort 3 | Part 1: Total Amount of RO7020531, RO7011785, RO7018822 and RO7033805 in Urine: SAD | RO7011785 | 18.2 mg | Standard Deviation 8.96 |
| Part 1 SAD: Cohort 3 | Part 1: Total Amount of RO7020531, RO7011785, RO7018822 and RO7033805 in Urine: SAD | RO7033805 | 0.00 mg | Standard Deviation 0 |
| Part 1 SAD: Cohort 3 | Part 1: Total Amount of RO7020531, RO7011785, RO7018822 and RO7033805 in Urine: SAD | RO7018822 | 0.271 mg | Standard Deviation 0.171 |
| Part 1 SAD: Cohort 4 | Part 1: Total Amount of RO7020531, RO7011785, RO7018822 and RO7033805 in Urine: SAD | RO7011785 | 25.5 mg | Standard Deviation 7.81 |
| Part 1 SAD: Cohort 4 | Part 1: Total Amount of RO7020531, RO7011785, RO7018822 and RO7033805 in Urine: SAD | RO7020531 | 0.00 mg | Standard Deviation 0 |
| Part 1 SAD: Cohort 4 | Part 1: Total Amount of RO7020531, RO7011785, RO7018822 and RO7033805 in Urine: SAD | RO7033805 | 0.00 mg | Standard Deviation 0 |
| Part 1 SAD: Cohort 4 | Part 1: Total Amount of RO7020531, RO7011785, RO7018822 and RO7033805 in Urine: SAD | RO7018822 | 0.372 mg | Standard Deviation 0.145 |
| Part 1 SAD: Cohort 5 | Part 1: Total Amount of RO7020531, RO7011785, RO7018822 and RO7033805 in Urine: SAD | RO7018822 | 0.728 mg | Standard Deviation 0.337 |
| Part 1 SAD: Cohort 5 | Part 1: Total Amount of RO7020531, RO7011785, RO7018822 and RO7033805 in Urine: SAD | RO7011785 | 48.1 mg | Standard Deviation 17.7 |
| Part 1 SAD: Cohort 5 | Part 1: Total Amount of RO7020531, RO7011785, RO7018822 and RO7033805 in Urine: SAD | RO7020531 | 0.00 mg | Standard Deviation 0 |
| Part 1 SAD: Cohort 5 | Part 1: Total Amount of RO7020531, RO7011785, RO7018822 and RO7033805 in Urine: SAD | RO7033805 | 0.00 mg | Standard Deviation 0 |
| Part 1 SAD: Cohort 6 | Part 1: Total Amount of RO7020531, RO7011785, RO7018822 and RO7033805 in Urine: SAD | RO7033805 | 0.00 mg | Standard Deviation 0 |
| Part 1 SAD: Cohort 6 | Part 1: Total Amount of RO7020531, RO7011785, RO7018822 and RO7033805 in Urine: SAD | RO7020531 | 0.00 mg | Standard Deviation 0 |
| Part 1 SAD: Cohort 6 | Part 1: Total Amount of RO7020531, RO7011785, RO7018822 and RO7033805 in Urine: SAD | RO7011785 | 68.6 mg | Standard Deviation 16.7 |
| Part 1 SAD: Cohort 6 | Part 1: Total Amount of RO7020531, RO7011785, RO7018822 and RO7033805 in Urine: SAD | RO7018822 | 1.10 mg | Standard Deviation 0.417 |
| Part 1 SAD: Cohort 7 | Part 1: Total Amount of RO7020531, RO7011785, RO7018822 and RO7033805 in Urine: SAD | RO7018822 | 1.87 mg | Standard Deviation 1 |
| Part 1 SAD: Cohort 7 | Part 1: Total Amount of RO7020531, RO7011785, RO7018822 and RO7033805 in Urine: SAD | RO7011785 | 83.5 mg | Standard Deviation 17.4 |
Secondary
Part 2: AUCinf of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805
Time frame: Predose and 0.25, 1, 2, 4, 6, 8, and 24 hours post dose on Days 1 and 41
Population: The PK analysis population included all participants randomized and adherent to the protocol. Number analyzed is the number of participants available at the specific timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1 Cohorts 1-8 SAD: Placebo | Part 2: AUCinf of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805 | RO7011785: Day 41 | 2740 h*ng/mL | Standard Deviation 762 |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 2: AUCinf of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805 | RO7018822: Day 41 | 498 h*ng/mL | Standard Deviation 176 |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 2: AUCinf of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805 | RO7018822: Day 1 | 338 h*ng/mL | Standard Deviation 147 |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 2: AUCinf of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805 | RO7011785: Day 1 | 2770 h*ng/mL | Standard Deviation 968 |
| Part 1 SAD: Cohort 1 | Part 2: AUCinf of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805 | RO7011785: Day 41 | 2500 h*ng/mL | Standard Deviation 655 |
| Part 1 SAD: Cohort 1 | Part 2: AUCinf of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805 | RO7011785: Day 1 | 2430 h*ng/mL | Standard Deviation 765 |
| Part 1 SAD: Cohort 1 | Part 2: AUCinf of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805 | RO7018822: Day 41 | 482 h*ng/mL | Standard Deviation 249 |
| Part 1 SAD: Cohort 1 | Part 2: AUCinf of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805 | RO7018822: Day 1 | 326 h*ng/mL | Standard Deviation 139 |
| Part 1 SAD: Cohort 2 | Part 2: AUCinf of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805 | RO7018822: Day 41 | 327 h*ng/mL | Standard Deviation 105 |
| Part 1 SAD: Cohort 2 | Part 2: AUCinf of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805 | RO7011785: Day 1 | 3060 h*ng/mL | Standard Deviation 1030 |
| Part 1 SAD: Cohort 2 | Part 2: AUCinf of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805 | RO7011785: Day 41 | 2960 h*ng/mL | Standard Deviation 909 |
| Part 1 SAD: Cohort 2 | Part 2: AUCinf of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805 | RO7018822: Day 1 | 374 h*ng/mL | Standard Deviation 261 |
| Unknown | Part 2: AUCinf of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805 | RO7020531: Day 1 | — h*ng/mL | — |
| Unknown | Part 2: AUCinf of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805 | RO7033805: Day 1 | — h*ng/mL | — |
| Unknown | Part 2: AUCinf of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805 | RO7020531: Day 41 | — h*ng/mL | — |
| Unknown | Part 2: AUCinf of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805 | RO7033805: Day 41 | — h*ng/mL | — |
Secondary
Part 2: AUClast of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805
Time frame: Predose and 0.25, 1, 2, 4, 6, 8, and 24 hours post dose on Days 1 and 41
Population: The PK analysis population included all participants randomized and adherent to the protocol. Number analyzed is the number of participants available at the specific timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1 Cohorts 1-8 SAD: Placebo | Part 2: AUClast of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805 | RO7033805: Day 41 | 0.566 h*ng/mL | — |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 2: AUClast of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805 | RO7011785: Day 1 | 2820 h*ng/mL | Standard Deviation 979 |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 2: AUClast of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805 | RO7011785: Day 41 | 2730 h*ng/mL | Standard Deviation 771 |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 2: AUClast of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805 | RO7018822: Day 1 | 220 h*ng/mL | Standard Deviation 124 |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 2: AUClast of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805 | RO7018822: Day 41 | 297 h*ng/mL | Standard Deviation 214 |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 2: AUClast of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805 | RO7020531: Day 1 | 0.213 h*ng/mL | — |
| Part 1 SAD: Cohort 1 | Part 2: AUClast of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805 | RO7011785: Day 41 | 2470 h*ng/mL | Standard Deviation 653 |
| Part 1 SAD: Cohort 1 | Part 2: AUClast of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805 | RO7018822: Day 1 | 253 h*ng/mL | Standard Deviation 127 |
| Part 1 SAD: Cohort 1 | Part 2: AUClast of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805 | RO7033805: Day 1 | 0.179 h*ng/mL | — |
| Part 1 SAD: Cohort 1 | Part 2: AUClast of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805 | RO7011785: Day 1 | 2400 h*ng/mL | Standard Deviation 762 |
| Part 1 SAD: Cohort 1 | Part 2: AUClast of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805 | RO7018822: Day 41 | 301 h*ng/mL | Standard Deviation 228 |
| Part 1 SAD: Cohort 2 | Part 2: AUClast of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805 | RO7018822: Day 41 | 243 h*ng/mL | Standard Deviation 87.8 |
| Part 1 SAD: Cohort 2 | Part 2: AUClast of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805 | RO7011785: Day 41 | 2930 h*ng/mL | Standard Deviation 915 |
| Part 1 SAD: Cohort 2 | Part 2: AUClast of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805 | RO7018822: Day 1 | 255 h*ng/mL | Standard Deviation 134 |
| Part 1 SAD: Cohort 2 | Part 2: AUClast of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805 | RO7011785: Day 1 | 3030 h*ng/mL | Standard Deviation 1040 |
Secondary
Part 2: Cmax of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805
Time frame: Predose and 0.25, 1, 2, 4, 6, 8, and 24 hours post dose on Days 1 and 41
Population: The PK analysis population included all participants randomized and adherent to the protocol. Number analyzed is the number of participants available at the specific timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1 Cohorts 1-8 SAD: Placebo | Part 2: Cmax of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805 | RO7033805: Day 41 | 1.51 ng/mL | — |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 2: Cmax of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805 | RO7011785: Day 1 | 1690 ng/mL | Standard Deviation 639 |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 2: Cmax of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805 | RO7011785: Day 41 | 1580 ng/mL | Standard Deviation 591 |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 2: Cmax of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805 | RO7018822: Day 1 | 167 ng/mL | Standard Deviation 93.2 |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 2: Cmax of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805 | RO7018822: Day 41 | 193 ng/mL | Standard Deviation 114 |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 2: Cmax of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805 | RO7020531: Day 1 | 1.70 ng/mL | — |
| Part 1 SAD: Cohort 1 | Part 2: Cmax of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805 | RO7011785: Day 41 | 1430 ng/mL | Standard Deviation 457 |
| Part 1 SAD: Cohort 1 | Part 2: Cmax of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805 | RO7018822: Day 1 | 203 ng/mL | Standard Deviation 110 |
| Part 1 SAD: Cohort 1 | Part 2: Cmax of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805 | RO7033805: Day 1 | 1.43 ng/mL | — |
| Part 1 SAD: Cohort 1 | Part 2: Cmax of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805 | RO7011785: Day 1 | 1500 ng/mL | Standard Deviation 668 |
| Part 1 SAD: Cohort 1 | Part 2: Cmax of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805 | RO7018822: Day 41 | 194 ng/mL | Standard Deviation 134 |
| Part 1 SAD: Cohort 2 | Part 2: Cmax of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805 | RO7018822: Day 41 | 184 ng/mL | Standard Deviation 90.9 |
| Part 1 SAD: Cohort 2 | Part 2: Cmax of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805 | RO7011785: Day 41 | 1990 ng/mL | Standard Deviation 999 |
| Part 1 SAD: Cohort 2 | Part 2: Cmax of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805 | RO7018822: Day 1 | 218 ng/mL | Standard Deviation 113 |
| Part 1 SAD: Cohort 2 | Part 2: Cmax of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805 | RO7011785: Day 1 | 1980 ng/mL | Standard Deviation 891 |
Secondary
Part 2: Mean Concentration of IFN-alpha
Mean concentrations of IFN-alpha for Part 2 were calculated following multiple doses. The SD presented is actually the log transformed geometric standard deviation.
Time frame: Predose, 6, 8 and 24 hrs Postdose on Day 1; Predose, 4-6, 24 hrs Postdose on Days 3, 7 and 21; Predose, 6, 24 hrs Postdose on Day 41
Population: Pharmacodynamic population included all participants who had received at least 1 dose of the study drug and with PD data available.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1 Cohorts 1-8 SAD: Placebo | Part 2: Mean Concentration of IFN-alpha | 0.0533 pg/mL | Standard Deviation 1.0668 |
| Part 1 SAD: Cohort 1 | Part 2: Mean Concentration of IFN-alpha | 0.3801 pg/mL | Standard Deviation 9.1442 |
| Part 1 SAD: Cohort 2 | Part 2: Mean Concentration of IFN-alpha | 0.2831 pg/mL | Standard Deviation 9.0521 |
| Part 1 SAD: Cohort 3 | Part 2: Mean Concentration of IFN-alpha | 0.0574 pg/mL | Standard Deviation 1.2737 |
| Part 1 SAD: Cohort 4 | Part 2: Mean Concentration of IFN-alpha | 0.3161 pg/mL | Standard Deviation 8.0853 |
Secondary
Part 2: Mean Fold Change From Baseline in Cytokine Markers
Cytokines markers included IP- 10, IL- 6, IL-1 10, IL-12 p40, Neopterin and TNF -alpha. The SD presented is actually the log transformed geometric standard deviation.
Time frame: Predose, 6, 8 and 24 hrs Postdose on Day 1; Predose, 4-6, 24 hrs Postdose on Days 3, 7 and 21; Predose, 6, 24 hrs Postdose on Day 41
Population: Pharmacodynamic population included all participants who had received at least 1 dose of the study drug and with PD data available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1 Cohorts 1-8 SAD: Placebo | Part 2: Mean Fold Change From Baseline in Cytokine Markers | IL-12 p40 | 1.0000 Fold change | Standard Deviation 1 |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 2: Mean Fold Change From Baseline in Cytokine Markers | Neopterin | 1.0473 Fold change | Standard Deviation 1.2426 |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 2: Mean Fold Change From Baseline in Cytokine Markers | IL-10 | 1.0428 Fold change | Standard Deviation 1.3767 |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 2: Mean Fold Change From Baseline in Cytokine Markers | IP-10 | 0.9007 Fold change | Standard Deviation 1.3368 |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 2: Mean Fold Change From Baseline in Cytokine Markers | TNF-alpha | 0.9848 Fold change | Standard Deviation 1.4186 |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 2: Mean Fold Change From Baseline in Cytokine Markers | IL-6 | 1.0172 Fold change | Standard Deviation 1.1251 |
| Part 1 SAD: Cohort 1 | Part 2: Mean Fold Change From Baseline in Cytokine Markers | IL-12 p40 | 1.0109 Fold change | Standard Deviation 1.1763 |
| Part 1 SAD: Cohort 1 | Part 2: Mean Fold Change From Baseline in Cytokine Markers | TNF-alpha | 1.2674 Fold change | Standard Deviation 1.6169 |
| Part 1 SAD: Cohort 1 | Part 2: Mean Fold Change From Baseline in Cytokine Markers | IL-10 | 1.2587 Fold change | Standard Deviation 1.5415 |
| Part 1 SAD: Cohort 1 | Part 2: Mean Fold Change From Baseline in Cytokine Markers | IP-10 | 2.2323 Fold change | Standard Deviation 2.681 |
| Part 1 SAD: Cohort 1 | Part 2: Mean Fold Change From Baseline in Cytokine Markers | Neopterin | 1.5596 Fold change | Standard Deviation 1.7824 |
| Part 1 SAD: Cohort 1 | Part 2: Mean Fold Change From Baseline in Cytokine Markers | IL-6 | 1.0909 Fold change | Standard Deviation 1.4962 |
| Part 1 SAD: Cohort 2 | Part 2: Mean Fold Change From Baseline in Cytokine Markers | IL-6 | 1.4235 Fold change | Standard Deviation 2.1969 |
| Part 1 SAD: Cohort 2 | Part 2: Mean Fold Change From Baseline in Cytokine Markers | TNF-alpha | 1.0527 Fold change | Standard Deviation 1.6605 |
| Part 1 SAD: Cohort 2 | Part 2: Mean Fold Change From Baseline in Cytokine Markers | IP-10 | 2.1018 Fold change | Standard Deviation 2.956 |
| Part 1 SAD: Cohort 2 | Part 2: Mean Fold Change From Baseline in Cytokine Markers | IL-12 p40 | 0.9624 Fold change | Standard Deviation 1.1261 |
| Part 1 SAD: Cohort 2 | Part 2: Mean Fold Change From Baseline in Cytokine Markers | Neopterin | 1.7935 Fold change | Standard Deviation 1.9267 |
| Part 1 SAD: Cohort 2 | Part 2: Mean Fold Change From Baseline in Cytokine Markers | IL-10 | 1.3441 Fold change | Standard Deviation 1.9726 |
| Part 1 SAD: Cohort 3 | Part 2: Mean Fold Change From Baseline in Cytokine Markers | IL-6 | 0.8127 Fold change | Standard Deviation 1.4478 |
| Part 1 SAD: Cohort 3 | Part 2: Mean Fold Change From Baseline in Cytokine Markers | IL-10 | 0.8232 Fold change | Standard Deviation 1.606 |
| Part 1 SAD: Cohort 3 | Part 2: Mean Fold Change From Baseline in Cytokine Markers | Neopterin | 1.0591 Fold change | Standard Deviation 1.5154 |
| Part 1 SAD: Cohort 3 | Part 2: Mean Fold Change From Baseline in Cytokine Markers | IP-10 | 0.8939 Fold change | Standard Deviation 1.3557 |
| Part 1 SAD: Cohort 3 | Part 2: Mean Fold Change From Baseline in Cytokine Markers | TNF-alpha | 1.0415 Fold change | Standard Deviation 1.3014 |
| Part 1 SAD: Cohort 3 | Part 2: Mean Fold Change From Baseline in Cytokine Markers | IL-12 p40 | 1.0000 Fold change | Standard Deviation 1 |
| Part 1 SAD: Cohort 4 | Part 2: Mean Fold Change From Baseline in Cytokine Markers | IL-12 p40 | 0.9740 Fold change | Standard Deviation 1.1886 |
| Part 1 SAD: Cohort 4 | Part 2: Mean Fold Change From Baseline in Cytokine Markers | Neopterin | 1.4676 Fold change | Standard Deviation 1.7203 |
| Part 1 SAD: Cohort 4 | Part 2: Mean Fold Change From Baseline in Cytokine Markers | IP-10 | 1.8598 Fold change | Standard Deviation 2.6359 |
| Part 1 SAD: Cohort 4 | Part 2: Mean Fold Change From Baseline in Cytokine Markers | TNF-alpha | 1.0418 Fold change | Standard Deviation 1.547 |
| Part 1 SAD: Cohort 4 | Part 2: Mean Fold Change From Baseline in Cytokine Markers | IL-10 | 1.2540 Fold change | Standard Deviation 1.8818 |
| Part 1 SAD: Cohort 4 | Part 2: Mean Fold Change From Baseline in Cytokine Markers | IL-6 | 1.1596 Fold change | Standard Deviation 1.6084 |
Secondary
Part 2: Mean Fold Change From Baseline in Markers of Transcriptional Responses
Transcriptional markers include mRNA ISG15, mRNA OAS1, mRNA MX-1, mRNA TLR7. The SD presented is actually the log transformed geometric standard deviation.
Time frame: Predose, 6, 8, 24 hrs postdose on Day 1; Predose, 4-6, 24 hrs postdose on Days 3, 7, 21; Predose, 6, 24 hrs postdose on Day 41
Population: Pharmacodynamic population included all participants who had received at least 1 dose of the study drug and with PD data available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1 Cohorts 1-8 SAD: Placebo | Part 2: Mean Fold Change From Baseline in Markers of Transcriptional Responses | mRNA ISG15 | 1.0745 Fold change | Standard Deviation 1.6135 |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 2: Mean Fold Change From Baseline in Markers of Transcriptional Responses | mRNA OAS1 | 0.9617 Fold change | Standard Deviation 1.2926 |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 2: Mean Fold Change From Baseline in Markers of Transcriptional Responses | mRNA Mx-1 | 0.9140 Fold change | Standard Deviation 1.4847 |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 2: Mean Fold Change From Baseline in Markers of Transcriptional Responses | mRNA TLR7 | 1.0848 Fold change | Standard Deviation 1.4306 |
| Part 1 SAD: Cohort 1 | Part 2: Mean Fold Change From Baseline in Markers of Transcriptional Responses | mRNA ISG15 | 4.2007 Fold change | Standard Deviation 3.9059 |
| Part 1 SAD: Cohort 1 | Part 2: Mean Fold Change From Baseline in Markers of Transcriptional Responses | mRNA TLR7 | 1.5280 Fold change | Standard Deviation 1.7527 |
| Part 1 SAD: Cohort 1 | Part 2: Mean Fold Change From Baseline in Markers of Transcriptional Responses | mRNA OAS1 | 3.1021 Fold change | Standard Deviation 2.6766 |
| Part 1 SAD: Cohort 1 | Part 2: Mean Fold Change From Baseline in Markers of Transcriptional Responses | mRNA Mx-1 | 3.1760 Fold change | Standard Deviation 3.2606 |
| Part 1 SAD: Cohort 2 | Part 2: Mean Fold Change From Baseline in Markers of Transcriptional Responses | mRNA TLR7 | 1.5745 Fold change | Standard Deviation 1.7411 |
| Part 1 SAD: Cohort 2 | Part 2: Mean Fold Change From Baseline in Markers of Transcriptional Responses | mRNA OAS1 | 4.0466 Fold change | Standard Deviation 2.7318 |
| Part 1 SAD: Cohort 2 | Part 2: Mean Fold Change From Baseline in Markers of Transcriptional Responses | mRNA Mx-1 | 5.0962 Fold change | Standard Deviation 3.3744 |
| Part 1 SAD: Cohort 2 | Part 2: Mean Fold Change From Baseline in Markers of Transcriptional Responses | mRNA ISG15 | 6.8997 Fold change | Standard Deviation 4.1313 |
| Part 1 SAD: Cohort 3 | Part 2: Mean Fold Change From Baseline in Markers of Transcriptional Responses | mRNA ISG15 | 0.8661 Fold change | Standard Deviation 1.5914 |
| Part 1 SAD: Cohort 3 | Part 2: Mean Fold Change From Baseline in Markers of Transcriptional Responses | mRNA OAS1 | 0.7973 Fold change | Standard Deviation 1.4425 |
| Part 1 SAD: Cohort 3 | Part 2: Mean Fold Change From Baseline in Markers of Transcriptional Responses | mRNA TLR7 | 1.0240 Fold change | Standard Deviation 1.362 |
| Part 1 SAD: Cohort 3 | Part 2: Mean Fold Change From Baseline in Markers of Transcriptional Responses | mRNA Mx-1 | 0.8296 Fold change | Standard Deviation 1.3309 |
| Part 1 SAD: Cohort 4 | Part 2: Mean Fold Change From Baseline in Markers of Transcriptional Responses | mRNA TLR7 | 1.3211 Fold change | Standard Deviation 1.9422 |
| Part 1 SAD: Cohort 4 | Part 2: Mean Fold Change From Baseline in Markers of Transcriptional Responses | mRNA Mx-1 | 3.4811 Fold change | Standard Deviation 2.9921 |
| Part 1 SAD: Cohort 4 | Part 2: Mean Fold Change From Baseline in Markers of Transcriptional Responses | mRNA OAS1 | 3.0355 Fold change | Standard Deviation 2.4692 |
| Part 1 SAD: Cohort 4 | Part 2: Mean Fold Change From Baseline in Markers of Transcriptional Responses | mRNA ISG15 | 3.9424 Fold change | Standard Deviation 3.366 |
Secondary
Part 2: Plasma Concentrations of Tenofovir, Tenofovir Alafenamide, Entecavir, Adefovir and Telbivudine
Adefovir was not administered to any participants in the study. Hence, no data could be collected for plasma concentration of adefovir. As participants in each cohort received different NUCs the data for Cohorts 1, 2 and 3 have been reported separately.
Time frame: Pre-dose and 2-4 hours post-dose on Day 1, Day 21 and Day 41
Population: The PK analysis population included all participants randomised and adherent to the protocol. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants available at the specific timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1 Cohorts 1-8 SAD: Placebo | Part 2: Plasma Concentrations of Tenofovir, Tenofovir Alafenamide, Entecavir, Adefovir and Telbivudine | Entecavir - Day 41: Predose | 0.406 ng/mL | Standard Deviation 0.1 |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 2: Plasma Concentrations of Tenofovir, Tenofovir Alafenamide, Entecavir, Adefovir and Telbivudine | Entecavir - Day 1: 2-4 hours Post Dose | 1.974 ng/mL | Standard Deviation 1.08 |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 2: Plasma Concentrations of Tenofovir, Tenofovir Alafenamide, Entecavir, Adefovir and Telbivudine | Entecavir - Day 21: Predose | 0.494 ng/mL | Standard Deviation 0.07 |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 2: Plasma Concentrations of Tenofovir, Tenofovir Alafenamide, Entecavir, Adefovir and Telbivudine | Entecavir - Day 21: 2-4 hours Post Dose | 1.543 ng/mL | Standard Deviation 0.76 |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 2: Plasma Concentrations of Tenofovir, Tenofovir Alafenamide, Entecavir, Adefovir and Telbivudine | Entecavir - Day 1: Predose | 0.467 ng/mL | Standard Deviation 0.13 |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 2: Plasma Concentrations of Tenofovir, Tenofovir Alafenamide, Entecavir, Adefovir and Telbivudine | Entecavir - Day 41: 2-4 hours Post Dose | 1.373 ng/mL | Standard Deviation 0.66 |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 2: Plasma Concentrations of Tenofovir, Tenofovir Alafenamide, Entecavir, Adefovir and Telbivudine | Tenofovir - Day 1: Predose | 54.93 ng/mL | Standard Deviation 32.7 |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 2: Plasma Concentrations of Tenofovir, Tenofovir Alafenamide, Entecavir, Adefovir and Telbivudine | Tenofovir - Day 1: 2-4 hours Post Dose | 155.1 ng/mL | Standard Deviation 106 |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 2: Plasma Concentrations of Tenofovir, Tenofovir Alafenamide, Entecavir, Adefovir and Telbivudine | Tenofovir - Day 21: Predose | 63.90 ng/mL | Standard Deviation 29.5 |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 2: Plasma Concentrations of Tenofovir, Tenofovir Alafenamide, Entecavir, Adefovir and Telbivudine | Tenofovir - Day 21: 2-4 hours Post Dose | 206.6 ng/mL | Standard Deviation 81.4 |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 2: Plasma Concentrations of Tenofovir, Tenofovir Alafenamide, Entecavir, Adefovir and Telbivudine | Tenofovir - Day 41: Predose | 66.82 ng/mL | Standard Deviation 34 |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 2: Plasma Concentrations of Tenofovir, Tenofovir Alafenamide, Entecavir, Adefovir and Telbivudine | Tenofovir - Day 41: 2-4 hours Post Dose | 250.9 ng/mL | Standard Deviation 108 |
| Part 1 SAD: Cohort 1 | Part 2: Plasma Concentrations of Tenofovir, Tenofovir Alafenamide, Entecavir, Adefovir and Telbivudine | Telbivudine - Day 21: Predose | 1030 ng/mL | Standard Deviation 1030 |
| Part 1 SAD: Cohort 1 | Part 2: Plasma Concentrations of Tenofovir, Tenofovir Alafenamide, Entecavir, Adefovir and Telbivudine | Entecavir - Day 41: Predose | 0.308 ng/mL | Standard Deviation 0.08 |
| Part 1 SAD: Cohort 1 | Part 2: Plasma Concentrations of Tenofovir, Tenofovir Alafenamide, Entecavir, Adefovir and Telbivudine | Entecavir - Day 41: 2-4 hours Post Dose | 1.267 ng/mL | Standard Deviation 0.5 |
| Part 1 SAD: Cohort 1 | Part 2: Plasma Concentrations of Tenofovir, Tenofovir Alafenamide, Entecavir, Adefovir and Telbivudine | Telbivudine - Day 21: 2-4 hours Post Dose | 2030 ng/mL | Standard Deviation 2030 |
| Part 1 SAD: Cohort 1 | Part 2: Plasma Concentrations of Tenofovir, Tenofovir Alafenamide, Entecavir, Adefovir and Telbivudine | Tenofovir - Day 1: Predose | 60.00 ng/mL | Standard Deviation 26.5 |
| Part 1 SAD: Cohort 1 | Part 2: Plasma Concentrations of Tenofovir, Tenofovir Alafenamide, Entecavir, Adefovir and Telbivudine | Tenofovir - Day 1: 2-4 hours Post Dose | 214.2 ng/mL | Standard Deviation 64 |
| Part 1 SAD: Cohort 1 | Part 2: Plasma Concentrations of Tenofovir, Tenofovir Alafenamide, Entecavir, Adefovir and Telbivudine | Telbivudine - Day 41: Predose | 935.0 ng/mL | Standard Deviation 935 |
| Part 1 SAD: Cohort 1 | Part 2: Plasma Concentrations of Tenofovir, Tenofovir Alafenamide, Entecavir, Adefovir and Telbivudine | Tenofovir - Day 21: Predose | 58.40 ng/mL | Standard Deviation 21.4 |
| Part 1 SAD: Cohort 1 | Part 2: Plasma Concentrations of Tenofovir, Tenofovir Alafenamide, Entecavir, Adefovir and Telbivudine | Tenofovir - Day 21: 2-4 hours Post Dose | 273.0 ng/mL | Standard Deviation 177 |
| Part 1 SAD: Cohort 1 | Part 2: Plasma Concentrations of Tenofovir, Tenofovir Alafenamide, Entecavir, Adefovir and Telbivudine | Telbivudine - Day 41: 2-4 hours Post Dose | 2850 ng/mL | Standard Deviation 2850 |
| Part 1 SAD: Cohort 1 | Part 2: Plasma Concentrations of Tenofovir, Tenofovir Alafenamide, Entecavir, Adefovir and Telbivudine | Tenofovir - Day 41: Predose | 64.06 ng/mL | Standard Deviation 32.7 |
| Part 1 SAD: Cohort 1 | Part 2: Plasma Concentrations of Tenofovir, Tenofovir Alafenamide, Entecavir, Adefovir and Telbivudine | Tenofovir - Day 41: 2-4 hours Post Dose | 250.4 ng/mL | Standard Deviation 112 |
| Part 1 SAD: Cohort 1 | Part 2: Plasma Concentrations of Tenofovir, Tenofovir Alafenamide, Entecavir, Adefovir and Telbivudine | Tenofovir Alafenamide - Day 1: 2-4 hours Post Dose | 0.058 ng/mL | Standard Deviation 0.058 |
| Part 1 SAD: Cohort 1 | Part 2: Plasma Concentrations of Tenofovir, Tenofovir Alafenamide, Entecavir, Adefovir and Telbivudine | Telbivudine - Day 1: Predose | 602.0 ng/mL | Standard Deviation 602 |
| Part 1 SAD: Cohort 1 | Part 2: Plasma Concentrations of Tenofovir, Tenofovir Alafenamide, Entecavir, Adefovir and Telbivudine | Entecavir - Day 1: Predose | 0.420 ng/mL | Standard Deviation 0.1 |
| Part 1 SAD: Cohort 1 | Part 2: Plasma Concentrations of Tenofovir, Tenofovir Alafenamide, Entecavir, Adefovir and Telbivudine | Entecavir - Day 1: 2-4 hours Post Dose | 1.455 ng/mL | Standard Deviation 0.53 |
| Part 1 SAD: Cohort 1 | Part 2: Plasma Concentrations of Tenofovir, Tenofovir Alafenamide, Entecavir, Adefovir and Telbivudine | Telbivudine - Day 1: 2-4 hours Post Dose | 4760 ng/mL | Standard Deviation 4760 |
| Part 1 SAD: Cohort 1 | Part 2: Plasma Concentrations of Tenofovir, Tenofovir Alafenamide, Entecavir, Adefovir and Telbivudine | Entecavir - Day 21: Predose | 0.365 ng/mL | Standard Deviation 0.09 |
| Part 1 SAD: Cohort 1 | Part 2: Plasma Concentrations of Tenofovir, Tenofovir Alafenamide, Entecavir, Adefovir and Telbivudine | Entecavir - Day 21: 2-4 hours Post Dose | 1.568 ng/mL | Standard Deviation 0.8 |
| Part 1 SAD: Cohort 2 | Part 2: Plasma Concentrations of Tenofovir, Tenofovir Alafenamide, Entecavir, Adefovir and Telbivudine | Telbivudine - Day 1: Predose | 330.0 ng/mL | Standard Deviation 330 |
| Part 1 SAD: Cohort 2 | Part 2: Plasma Concentrations of Tenofovir, Tenofovir Alafenamide, Entecavir, Adefovir and Telbivudine | Entecavir - Day 41: Predose | 0.887 ng/mL | Standard Deviation 0.89 |
| Part 1 SAD: Cohort 2 | Part 2: Plasma Concentrations of Tenofovir, Tenofovir Alafenamide, Entecavir, Adefovir and Telbivudine | Telbivudine - Day 21: Predose | 314.0 ng/mL | Standard Deviation 314 |
| Part 1 SAD: Cohort 2 | Part 2: Plasma Concentrations of Tenofovir, Tenofovir Alafenamide, Entecavir, Adefovir and Telbivudine | Tenofovir - Day 41: Predose | 56.56 ng/mL | Standard Deviation 26.3 |
| Part 1 SAD: Cohort 2 | Part 2: Plasma Concentrations of Tenofovir, Tenofovir Alafenamide, Entecavir, Adefovir and Telbivudine | Entecavir - Day 41: 2-4 hours Post Dose | 1.427 ng/mL | Standard Deviation 0.69 |
| Part 1 SAD: Cohort 2 | Part 2: Plasma Concentrations of Tenofovir, Tenofovir Alafenamide, Entecavir, Adefovir and Telbivudine | Telbivudine - Day 41: 2-4 hours Post Dose | 2450 ng/mL | Standard Deviation 2450 |
| Part 1 SAD: Cohort 2 | Part 2: Plasma Concentrations of Tenofovir, Tenofovir Alafenamide, Entecavir, Adefovir and Telbivudine | Entecavir - Day 21: Predose | 0.810 ng/mL | Standard Deviation 0.92 |
| Part 1 SAD: Cohort 2 | Part 2: Plasma Concentrations of Tenofovir, Tenofovir Alafenamide, Entecavir, Adefovir and Telbivudine | Tenofovir - Day 1: Predose | 71.12 ng/mL | Standard Deviation 35.7 |
| Part 1 SAD: Cohort 2 | Part 2: Plasma Concentrations of Tenofovir, Tenofovir Alafenamide, Entecavir, Adefovir and Telbivudine | Telbivudine - Day 21: 2-4 hours Post Dose | 1790 ng/mL | Standard Deviation 1790 |
| Part 1 SAD: Cohort 2 | Part 2: Plasma Concentrations of Tenofovir, Tenofovir Alafenamide, Entecavir, Adefovir and Telbivudine | Tenofovir - Day 41: 2-4 hours Post Dose | 188.4 ng/mL | Standard Deviation 58.7 |
| Part 1 SAD: Cohort 2 | Part 2: Plasma Concentrations of Tenofovir, Tenofovir Alafenamide, Entecavir, Adefovir and Telbivudine | Tenofovir - Day 1: 2-4 hours Post Dose | 245.0 ng/mL | Standard Deviation 49.8 |
| Part 1 SAD: Cohort 2 | Part 2: Plasma Concentrations of Tenofovir, Tenofovir Alafenamide, Entecavir, Adefovir and Telbivudine | Entecavir - Day 1: 2-4 hours Post Dose | 1.019 ng/mL | Standard Deviation 0.6 |
| Part 1 SAD: Cohort 2 | Part 2: Plasma Concentrations of Tenofovir, Tenofovir Alafenamide, Entecavir, Adefovir and Telbivudine | Telbivudine - Day 1: 2-4 hours Post Dose | 2820 ng/mL | Standard Deviation 2820 |
| Part 1 SAD: Cohort 2 | Part 2: Plasma Concentrations of Tenofovir, Tenofovir Alafenamide, Entecavir, Adefovir and Telbivudine | Tenofovir - Day 21: Predose | 57.02 ng/mL | Standard Deviation 28 |
| Part 1 SAD: Cohort 2 | Part 2: Plasma Concentrations of Tenofovir, Tenofovir Alafenamide, Entecavir, Adefovir and Telbivudine | Telbivudine - Day 41: Predose | 260.0 ng/mL | Standard Deviation 260 |
| Part 1 SAD: Cohort 2 | Part 2: Plasma Concentrations of Tenofovir, Tenofovir Alafenamide, Entecavir, Adefovir and Telbivudine | Entecavir - Day 21: 2-4 hours Post Dose | 0.935 ng/mL | Standard Deviation 0.2 |
| Part 1 SAD: Cohort 2 | Part 2: Plasma Concentrations of Tenofovir, Tenofovir Alafenamide, Entecavir, Adefovir and Telbivudine | Tenofovir - Day 21: 2-4 hours Post Dose | 222.2 ng/mL | Standard Deviation 70.8 |
| Part 1 SAD: Cohort 2 | Part 2: Plasma Concentrations of Tenofovir, Tenofovir Alafenamide, Entecavir, Adefovir and Telbivudine | Entecavir - Day 1: Predose | 0.590 ng/mL | Standard Deviation 0.62 |
Secondary
Part 2: t1/2 of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805
Time frame: Predose and 0.25, 1, 2, 4, 6, 8, and 24 hours post dose on Days 1 and 41
Population: The PK analysis population included all participants randomized and adherent to the protocol. Number analyzed is the number of participants available at the specific timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1 Cohorts 1-8 SAD: Placebo | Part 2: t1/2 of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805 | RO7011785: Day 41 | 3.09 hr | Standard Deviation 0.697 |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 2: t1/2 of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805 | RO7018822: Day 41 | 0.776 hr | Standard Deviation 0.146 |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 2: t1/2 of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805 | RO7018822: Day 1 | 1.19 hr | Standard Deviation 0.886 |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 2: t1/2 of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805 | RO7011785: Day 1 | 3.09 hr | Standard Deviation 0.982 |
| Part 1 SAD: Cohort 1 | Part 2: t1/2 of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805 | RO7011785: Day 41 | 2.77 hr | Standard Deviation 1.19 |
| Part 1 SAD: Cohort 1 | Part 2: t1/2 of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805 | RO7011785: Day 1 | 2.63 hr | Standard Deviation 1.19 |
| Part 1 SAD: Cohort 1 | Part 2: t1/2 of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805 | RO7018822: Day 41 | 0.714 hr | Standard Deviation 0.112 |
| Part 1 SAD: Cohort 1 | Part 2: t1/2 of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805 | RO7018822: Day 1 | 0.665 hr | Standard Deviation 0.0431 |
| Part 1 SAD: Cohort 2 | Part 2: t1/2 of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805 | RO7018822: Day 41 | 0.720 hr | Standard Deviation 0.774 |
| Part 1 SAD: Cohort 2 | Part 2: t1/2 of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805 | RO7011785: Day 1 | 3.06 hr | Standard Deviation 0.934 |
| Part 1 SAD: Cohort 2 | Part 2: t1/2 of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805 | RO7011785: Day 41 | 2.90 hr | Standard Deviation 0.98 |
| Part 1 SAD: Cohort 2 | Part 2: t1/2 of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805 | RO7018822: Day 1 | 0.648 hr | Standard Deviation 0.0317 |
| Unknown | Part 2: t1/2 of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805 | RO7020531: Day 1 | — hr | — |
| Unknown | Part 2: t1/2 of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805 | RO7033805: Day 1 | — hr | — |
| Unknown | Part 2: t1/2 of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805 | RO7020531: Day 41 | — hr | — |
| Unknown | Part 2: t1/2 of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805 | RO7033805: Day 41 | — hr | — |
Secondary
Part 2: Tmax of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805
Time frame: Predose and 0.25, 1, 2, 4, 6, 8, and 24 hours post dose on Days 1 and 41
Population: The PK analysis population included all participants randomized and adherent to the protocol. Number analyzed is the number of participants available at the specific timepoints.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part 1 Cohorts 1-8 SAD: Placebo | Part 2: Tmax of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805 | RO7011785: Day 1 | 1.00 hr |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 2: Tmax of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805 | RO7018822: Day 41 | 1.00 hr |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 2: Tmax of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805 | RO7018822: Day 1 | 1.00 hr |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 2: Tmax of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805 | RO7020531: Day 1 | 0.25 hr |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 2: Tmax of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805 | RO7033805: Day 41 | 1.00 hr |
| Part 1 Cohorts 1-8 SAD: Placebo | Part 2: Tmax of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805 | RO7011785: Day 41 | 1.040 hr |
| Part 1 SAD: Cohort 1 | Part 2: Tmax of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805 | RO7033805: Day 1 | 0.25 hr |
| Part 1 SAD: Cohort 1 | Part 2: Tmax of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805 | RO7011785: Day 1 | 1.00 hr |
| Part 1 SAD: Cohort 1 | Part 2: Tmax of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805 | RO7011785: Day 41 | 1.00 hr |
| Part 1 SAD: Cohort 1 | Part 2: Tmax of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805 | RO7018822: Day 1 | 1.00 hr |
| Part 1 SAD: Cohort 1 | Part 2: Tmax of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805 | RO7018822: Day 41 | 1.00 hr |
| Part 1 SAD: Cohort 2 | Part 2: Tmax of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805 | RO7011785: Day 41 | 1.00 hr |
| Part 1 SAD: Cohort 2 | Part 2: Tmax of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805 | RO7011785: Day 1 | 1.00 hr |
| Part 1 SAD: Cohort 2 | Part 2: Tmax of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805 | RO7018822: Day 41 | 1.00 hr |
| Part 1 SAD: Cohort 2 | Part 2: Tmax of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805 | RO7018822: Day 1 | 1.00 hr |