A Study in Healthy Volunteers and in Participants With Ch... | NCT02956850 | Trialant
NCT02956850
Sponsor
Hoffmann-La Roche
Status
Completed
Last Update Posted
Feb 8, 2024Actual
Enrollment
160Actual
Phase
Phase 1
Conditions
Hepatitis B, Chronic
Interventions
Placebo
RO7020531
Countries
Bulgaria
Hong Kong
Italy
Netherlands
New Zealand
Taiwan
Thailand
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT02956850
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
NP39305
Secondary IDs
ID
Type
Description
Link
2016-003723-38
EudraCT Number
Brief Title
A Study in Healthy Volunteers and in Participants With Chronic Hepatitis B to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of RO7020531
Official Title
A Phase I, Sponsor-Open, Investigator-Blinded, Subject-Blinded, Multi-Center, Placebo-Controlled Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral Administration of RO7020531: (1). Single and Multiple Ascending Doses in Healthy Male and Female Subjects; (2). 6-week Treatment of Patients With Chronic Hepatitis B Virus Infection
Acronym
Not provided
Organization
Hoffmann-La RocheINDUSTRY
Status Module
Record Verification Date
Feb 2024
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Dec 12, 2016Actual
Primary Completion Date
Jun 15, 2021Actual
Completion Date
Jun 15, 2021Actual
First Submitted Date
Nov 3, 2016
First Submission Date that Met QC Criteria
Nov 3, 2016
First Posted Date
Nov 7, 2016Estimated
Results Waived
Not provided
Results First Submitted Date
Jun 7, 2022
Results First Submitted that Met QC Criteria
Feb 6, 2024
Results First Posted Date
Feb 8, 2024Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Feb 6, 2024
Last Update Posted Date
Feb 8, 2024Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Hoffmann-La RocheINDUSTRY
Collaborators
Not provided
Oversight Module
No data available
No data is available for this block.
Description Module
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.
Detailed Description
Not provided
Conditions Module
Conditions
Hepatitis B, Chronic
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
160Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Part I: SAD in Healthy Volunteers
Experimental
Healthy volunteers will receive single dose of RO7020531 or matching placebo orally on Day 1 of each cohort. A planned dose-escalation sequence for SAD is 3 milligrams (mg), 10 mg, 20 mg, 40 mg, 60 mg, 100 mg, 140 mg, and 170 mg.
Other: Placebo
Drug: RO7020531
Part I: MAD in Healthy Volunteers
Experimental
Healthy volunteers will receive RO7020531 (100 mg, 140 mg, and 170 mg as selected based on safety, pharmacokinetic (PK) and pharmacodynamic (PD) data of SAD cohorts) or matching placebo orally every other day (QOD) from Day 1 through to Day 13.
Other: Placebo
Drug: RO7020531
Part II: CHB Participants
Experimental
CHB participants will receive RO7020531 (150 mg and 170 mg as selected based on safety, PK and PD data of MAD cohorts) or matching placebo orally QOD from Day 1 through to Day 41, unless in Cohort 4 in case of once a week (QW) dosing as dose modification.
Other: Placebo
Drug: RO7020531
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Placebo
Other
Placebo matching to RO7020531 will be administered as per schedule specified in the respective arm.
Part I: MAD in Healthy Volunteers
Part I: SAD in Healthy Volunteers
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
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.
From randomization up to Day 29
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.
From randomization up to Day 41
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.
From randomization up to Week 12
Secondary Outcomes
Measure
Description
Time Frame
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 2: Cmax of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
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
Accepts Healthy Volunteers
Yes
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
65 Years
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Clinical Trials
Hoffmann-La Roche
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Gastroenterology department, Second clinic of internal diseases
Yuen MF, Balabanska R, Cottreel E, Chen E, Duan D, Jiang Q, Patil A, Triyatni M, Upmanyu R, Zhu Y, Canducci F, Gane EJ. TLR7 agonist RO7020531 versus placebo in healthy volunteers and patients with chronic hepatitis B virus infection: a randomised, observer-blind, placebo-controlled, phase 1 trial. Lancet Infect Dis. 2023 Apr;23(4):496-507. doi: 10.1016/S1473-3099(22)00727-7. Epub 2022 Dec 9.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
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.
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.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Part 1 Cohorts 1-8, Single Ascending Dose (SAD): Placebo
In SAD Cohorts 1-8, sixteen healthy volunteers (HVs), two in each cohort, received a single dose of RO7020531 matching placebo, on Day 1
FG001
Part 1 SAD: Cohort 1
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot_SAP
Yes
Yes
No
Study Protocol and Statistical Analysis Plan
Jun 24, 2020
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
South Korea
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
Part II: CHB Participants
RO7020531
Drug
RO7020531 will be administered as per schedule specified in the respective arm.
Part I: MAD in Healthy Volunteers
Part I: SAD in Healthy Volunteers
Part II: CHB Participants
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.
From randomization up to Day 8
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.
From randomization up to Day 20
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.
From randomization up to Week 12
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.
From randomization up to Day 8
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.
From randomization up to Day 20
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.
From randomization up to Week 12
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).
From randomization up to Day 8
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).
From randomization up to Day 20
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).
From randomization up to Week 12
Predose and 0.25, 1, 2, 4, 6, 8, and 24 hours post dose on Days 1 and 41
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
Total amount of the study drug and metabolites recovered in urine was reported.
0 to 24 hrs Postdose on Day 1
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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
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.
Pre-dose and 2-4 hours post-dose on Day 1, Day 21 and Day 41
Sofia
1612
Bulgaria
Queen Mary Hospital
Hong Kong
999077
Hong Kong
The Chinese University of Hong Kong
Shatin
123456
Hong Kong
Azienda Ospedaliero Universitaria Di Modena Policlinico; U.O. Farmacia
Modena
Emilia-Romagna
41124
Italy
ASST PAPA GIOVANNI XXIII; Epatologia e gastroenterologia pediatrica e dei trapianti
Bergamo
Lombardy
24127
Italy
Medicina Generale ed Epatologia (Humanitas-Rozzano)
Rozzano
Lombardy
20089
Italy
Academisch Medisch Centrum Universiteit Amsterdam; Dermatology and VU University Medical Center
Amsterdam
1100 DD
Netherlands
Auckland Clinical Studies
Auckland
1142
New Zealand
National Cheng Kung University Hospital
Tainan
70457
Taiwan
Taipei Veterans General Hospital
Taipei
112
Taiwan
Chang Gung Memorial Hospital
Taoyuan
333
Taiwan
Taichung Veterans General Hospital
Xitun Dist.
40705
Taiwan
King Chulalongkorn Memorial Hospital
Bangkok
10330
Thailand
Siriraj Hospital
Bangkok
10700
Thailand
Maharaj Nakorn Chiang Mai Hospital
Chiang Mai
50200
Thailand
Royal Liverpool University Hospital
Liverpool
L7 8XP
United Kingdom
King College Hospital NHS Foundation Trust
London
SE5 9RS
United Kingdom
HVs received single dose of RO7020531, 3 milligrams (mg), orally on Day 1.
FG002
Part 1 SAD: Cohort 2
HVs received single dose of RO7020531, 10 mg, orally on Day 1.
FG003
Part 1 SAD: Cohort 3
HVs received single dose of RO7020531, 20 mg, orally on Day 1.
FG004
Part 1 SAD: Cohort 4
HVs received single dose of RO7020531, 40 mg, orally on Day 1.
FG005
Part 1 SAD: Cohort 5
HVs received single dose of RO7020531, 60 mg, orally on Day 1.
FG006
Part 1 SAD: Cohort 6
HVs received single dose of RO7020531, 100 mg, orally on Day 1.
FG007
Part 1 SAD: Cohort 7
HVs received single dose of RO7020531, 140 mg, orally on Day 1.
FG008
Part 1 SAD: Cohort 8
HVs received single dose of RO7020531, 170 mg, orally on Day 1.
FG009
Part 1 Cohorts 1-3, Multiple Ascending Dose (MAD): Placebo
In MAD Cohorts 1,2, and 3, six HVs, two in each cohort, received RO7020531 matching placebo orally on Day 1 and every other day (QOD) for 13 days.
FG010
Part 1 MAD: Cohort 1
HVs received RO7020531, 100 mg, orally, on Day 1 and QOD for 13 days.
FG011
Part 1 MAD: Cohort 2
HVs received RO7020531, 140 mg, orally, on Day 1 and QOD for 13 days.
FG012
Part 1 MAD: Cohort 3
HVs received RO7020531, 170 mg, orally, on Day 1 and QOD for 13 days.
FG013
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 nucleoside/nucleotide analogue (NUC) treatment, orally, on Day 1 and QOD for 41 days.
FG014
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.
FG015
Part 2: Cohort 3
Participants received RO7020531, 170 mg, along with NUC treatment, orally, on Day 1 and QOD for 41 days.
FG016
Part 2 Cohort 4: Placebo
Treatment naive participants received RO7020531 matching placebo, orally, on Day 1 and QOD for 41 days.
FG017
Part 2: Cohort 4
Treatment naive participants received RO7020531, 150 mg, orally, on Day 1 and QOD for 41 days.
FG00016 subjects
FG0018 subjects
FG0028 subjects
FG0038 subjects
FG0048 subjects
FG0058 subjects
FG0068 subjects
FG0078 subjects
FG0088 subjects
FG0096 subjects
FG0108 subjects
FG0118 subjects
FG0128 subjects
FG0136 subjects
FG01416 subjects
FG0158 subjects
FG0165 subjects
FG01715 subjects
COMPLETED
FG00016 subjects
FG0018 subjects
FG0028 subjects
FG0038 subjects
FG0048 subjects
FG0058 subjects
FG0068 subjects
FG0078 subjects
FG0088 subjects
FG0096 subjects
FG0108 subjects
FG0118 subjects
FG0128 subjects
FG0136 subjects
FG01416 subjects
FG0158 subjects
FG0165 subjects
FG01714 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0171 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0171 subjects
Safety population included all participants who had received at least 1 dose of the study drug.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
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.
BG001
Part 1 SAD: Cohort 1
HVs received single dose of RO7020531, 3 mg, orally on Day 1.
BG002
Part 1 SAD: Cohort 2
HVs received single dose of RO7020531, 10 mg, orally on Day 1.
BG003
Part 1 SAD: Cohort 3
HVs received single dose of RO7020531, 20 mg, orally on Day 1.
BG004
Part 1 SAD: Cohort 4
HVs received single dose of RO7020531, 40 mg, orally on Day 1.
BG005
Part 1 SAD: Cohort 5
HVs received single dose of RO7020531, 60 mg, orally on Day 1.
BG006
Part 1 SAD: Cohort 6
HVs received single dose of RO7020531, 100 mg, orally on Day 1.
BG007
Part 1 SAD: Cohort 7
HVs received single dose of RO7020531, 140 mg, orally on Day 1.
BG008
Part 1 SAD: Cohort 8
HVs received single dose of RO7020531, 170 mg, orally on Day 1.
BG009
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.
BG010
Part 1 MAD: Cohort 1
HVs received RO7020531, 100 mg, orally, on Day 1 and QOD for 13 days.
BG011
Part 1 MAD: Cohort 2
HVs received RO7020531, 140 mg, orally, on Day 1 and QOD for 13 days.
BG012
Part 1 MAD: Cohort 3
HVs received RO7020531, 170 mg, orally, on Day 1 and QOD for 13 days.
BG013
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.
BG014
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.
BG015
Part 2: Cohort 3
Participants received RO7020531, 170 mg, along with NUC treatment, orally, on Day 1 and QOD for 41 days.
BG016
Part 2 Cohort 4: Placebo
Treatment naive participants received RO7020531 matching placebo, orally, on Day 1 and QOD for 41 days.
BG017
Part 2: Cohort 4
Treatment naive participants received RO7020531, 150 mg, orally, on Day 1 and QOD for 41 days.
BG018
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00016
BG0018
BG0028
BG0038
BG0048
BG0058
BG0068
BG0078
BG0088
BG0096
BG0108
BG0118
BG0128
BG0136
BG01416
BG0158
BG0165
BG01715
BG018160
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00028.7± 10.1
BG00131.5± 15.8
BG00237.6± 16.2
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0005
BG0012
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Hispanic or Latino
Title
Measurements
BG0002
BG0010
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Asian
Title
Measurements
BG0002
BG0012
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
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.
Safety analysis population included all HVs who had received at least 1 dose of study drug.
Posted
Number
percentage of participants
From randomization up to Day 29
ID
Title
Description
OG000
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.
OG001
Part 1 SAD: Cohort 1
HVs received single dose of RO7020531, 3 mg, orally on Day 1.
OG002
Part 1 SAD: Cohort 2
HVs received single dose of RO7020531, 10 mg, orally on Day 1.
OG003
Part 1 SAD: Cohort 3
HVs received single dose of RO7020531, 20 mg, orally on Day 1.
OG004
Part 1 SAD: Cohort 4
HVs received single dose of RO7020531, 40 mg, orally on Day 1.
OG005
Part 1 SAD: Cohort 5
HVs received single dose of RO7020531, 60 mg, orally on Day 1.
OG006
Part 1 SAD: Cohort 6
HVs received single dose of RO7020531, 100 mg, orally on Day 1.
OG007
Part 1 SAD: Cohort 7
HVs received single dose of RO7020531, 140 mg, orally on Day 1.
OG008
Part 1 SAD: Cohort 8
HVs received single dose of RO7020531, 170 mg, orally on Day 1.
Units
Counts
Participants
OG00016
OG0018
OG0028
OG003
Title
Denominators
Categories
Title
Measurements
OG00031.3
OG00125.0
OG00250.0
OG003
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.
Safety analysis population included all HVs who had received at least 1 dose of study drug.
Posted
Number
percentage of participants
From randomization up to Day 41
ID
Title
Description
OG000
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.
OG001
Part 1 MAD: Cohort 1
HVs received RO7020531, 100 mg, orally, on Day 1 and QOD for 13 days.
OG002
Part 1 MAD: Cohort 2
HVs received RO7020531, 140 mg, orally, on Day 1 and QOD for 13 days.
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.
Safety analysis population included all participants who had received at least 1 dose of study drug.
Posted
Number
percentage of participants
From randomization up to Week 12
ID
Title
Description
OG000
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.
OG001
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.
OG002
Secondary
Part 1: Maximum Observed Plasma Concentration (Cmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD
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.
Posted
Mean
Standard Deviation
nanograms per milliliter (ng/mL)
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
ID
Title
Description
OG000
Part 1 SAD: Cohort 1
HVs received single dose of RO7020531, 3 mg, orally on Day 1.
OG001
Part 1 SAD: Cohort 2
HVs received single dose of RO7020531, 10 mg, orally on Day 1.
OG002
Part 1 SAD: Cohort 3
HVs received single dose of RO7020531, 20 mg, orally on Day 1.
OG003
Part 1 SAD: Cohort 4
HVs received single dose of RO7020531, 40 mg, orally on Day 1.
Secondary
Part 2: Cmax of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805
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.
Posted
Mean
Standard Deviation
ng/mL
Predose and 0.25, 1, 2, 4, 6, 8, and 24 hours post dose on Days 1 and 41
ID
Title
Description
OG000
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.
OG001
Part 2: Cohort 4
Treatment naive participants received RO7020531, 150 mg, orally, on Day 1 and QOD for 41 days.
OG002
Part 2: Cohort 3
Participants received RO7020531, 170 mg, along with NUC treatment, orally on Day 1 and QOD for 41 days.
Units
Counts
Participants
Secondary
Part 1: Time to Maximum Observed Plasma Concentration (Tmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD
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.
Posted
Median
Full Range
hours (hr)
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
ID
Title
Description
OG000
Part 1 SAD: Cohort 1
HVs received single dose of RO7020531, 3 mg, orally on Day 1.
OG001
Part 1 SAD: Cohort 2
HVs received single dose of RO7020531, 10 mg, orally on Day 1.
OG002
Part 1 SAD: Cohort 3
HVs received single dose of RO7020531, 20 mg, orally on Day 1.
OG003
Part 1 SAD: Cohort 4
HVs received single dose of RO7020531, 40 mg, orally on Day 1.
Secondary
Part 2: Tmax of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805
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.
Posted
Median
Full Range
hr
Predose and 0.25, 1, 2, 4, 6, 8, and 24 hours post dose on Days 1 and 41
ID
Title
Description
OG000
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.
OG001
Part 2: Cohort 4
Treatment naive participants received RO7020531, 150 mg, orally, on Day 1 and QOD for 41 days.
OG002
Part 2: Cohort 3
Participants received RO7020531, 170 mg, along with NUC treatment, orally, on Day 1 and QOD for 41 days.
Units
Counts
Participants
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
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.
Posted
Mean
Standard Deviation
hours*nanogram per milliliter (h*ng/mL)
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
ID
Title
Description
OG000
Part 1 SAD: Cohort 1
HVs received single dose of RO7020531, 3 mg, orally on Day 1.
OG001
Part 1 SAD: Cohort 2
HVs received single dose of RO7020531, 10 mg, orally on Day 1.
OG002
Part 1 SAD: Cohort 3
HVs received single dose of RO7020531, 20 mg, orally on Day 1.
OG003
Part 1 SAD: Cohort 4
HVs received single dose of RO7020531, 40 mg, orally on Day 1.
Secondary
Part 2: AUCinf of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805
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.
Posted
Mean
Standard Deviation
h*ng/mL
Predose and 0.25, 1, 2, 4, 6, 8, and 24 hours post dose on Days 1 and 41
ID
Title
Description
OG000
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.
OG001
Part 2: Cohort 4
Treatment naive participants received RO7020531, 150 mg, orally, on Day 1 and QOD for 41 days.
OG002
Part 2: Cohort 3
Participants received RO7020531, 170 mg, along with NUC treatment, orally, on Day 1 and QOD for 41 days.
Units
Counts
Participants
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
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.
Posted
Mean
Standard Deviation
h*ng/mL
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
ID
Title
Description
OG000
Part 1 SAD: Cohort 1
HVs received single dose of RO7020531, 3 mg, orally on Day 1.
OG001
Part 1 SAD: Cohort 2
HVs received single dose of RO7020531, 10 mg, orally on Day 1.
OG002
Part 1 SAD: Cohort 3
HVs received single dose of RO7020531, 20 mg, orally on Day 1.
OG003
Part 1 SAD: Cohort 4
HVs received single dose of RO7020531, 40 mg, orally on Day 1.
Secondary
Part 2: AUClast of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805
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.
Posted
Mean
Standard Deviation
h*ng/mL
Predose and 0.25, 1, 2, 4, 6, 8, and 24 hours post dose on Days 1 and 41
ID
Title
Description
OG000
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.
OG001
Part 2: Cohort 4
Treatment naive participants received RO7020531, 150 mg, orally, on Day 1 and QOD for 41 days.
OG002
Part 2: Cohort 3
Participants received RO7020531, 170 mg, along with NUC treatment, orally, on Day 1 and QOD for 41 days.
Units
Counts
Participants
Secondary
Part 1: Half Life (t1/2) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD
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.
Posted
Mean
Standard Deviation
hr
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
ID
Title
Description
OG000
Part 1 SAD: Cohort 1
HVs received single dose of RO7020531, 3 mg, orally on Day 1.
OG001
Part 1 SAD: Cohort 2
HVs received single dose of RO7020531, 10 mg, orally on Day 1.
OG002
Part 1 SAD: Cohort 3
HVs received single dose of RO7020531, 20 mg, orally on Day 1.
OG003
Part 1 SAD: Cohort 4
HVs received single dose of RO7020531, 40 mg, orally on Day 1.
OG004
Secondary
Part 2: t1/2 of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805
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.
Posted
Mean
Standard Deviation
hr
Predose and 0.25, 1, 2, 4, 6, 8, and 24 hours post dose on Days 1 and 41
ID
Title
Description
OG000
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.
OG001
Part 2: Cohort 4
Treatment naive participants received RO7020531, 150 mg, orally, on Day 1 and QOD for 41 days.
OG002
Part 2: Cohort 3
Participants received RO7020531, 170 mg, along with NUC treatment, orally, on Day 1 and QOD for 41 days.
Units
Counts
Participants
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.
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.
Posted
Mean
Standard Deviation
mg
0 to 24 hrs Postdose on Day 1
ID
Title
Description
OG000
Part 1 SAD: Cohort 1
HVs received single dose of RO7020531, 3 mg, orally on Day 1.
OG001
Part 1 SAD: Cohort 2
HVs received single dose of RO7020531, 10 mg, orally on Day 1.
OG002
Part 1 SAD: Cohort 3
HVs received single dose of RO7020531, 20 mg, orally on Day 1.
OG003
Part 1 SAD: Cohort 4
HVs received single dose of RO7020531, 40 mg, orally on Day 1.
OG004
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.
Pharmacodynamic population included all HVs who had received at least 1 dose of the study drug and with PD data available.
Posted
Geometric Mean
Standard Deviation
picogram per milliliter (pg/mL)
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
ID
Title
Description
OG000
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.
OG001
Part 1 SAD: Cohort 1
HVs received single dose of RO7020531, 3 mg, orally on Day 1.
OG002
Part 1 SAD: Cohort 2
HVs received single dose of RO7020531, 10 mg, orally on Day 1.
OG003
Part 1 SAD: Cohort 3
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.
Pharmacodynamic population included all participants who had received at least 1 dose of the study drug and with PD data available.
Posted
Geometric Mean
Standard Deviation
pg/mL
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
ID
Title
Description
OG000
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.
OG001
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.
OG002
Part 2 Cohort 3
Participants received RO7020531, 170 mg, along with NUC treatment, orally, on Day 1 and QOD for 41 days.
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.
Pharmacodynamic population included all HVs who had received at least 1 dose of the study drug and with PD data available.
Posted
Geometric Mean
Standard Deviation
Fold change
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
ID
Title
Description
OG000
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.
OG001
Part 1 SAD: Cohort 1
HVs received single dose of RO7020531, 3 mg, orally on Day 1.
OG002
Part 1 SAD: Cohort 2
HVs received single dose of RO7020531, 10 mg, orally on Day 1.
OG003
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.
Pharmacodynamic population included all participants who had received at least 1 dose of the study drug and with PD data available.
Posted
Geometric Mean
Standard Deviation
Fold change
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
ID
Title
Description
OG000
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.
OG001
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.
OG002
Part 2 Cohort 3
Participants received RO7020531, 170 mg, along with NUC treatment, orally, on Day 1 and QOD for 41 days.
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.
Pharmacodynamic population included all HVs who had received at least 1 dose of the study drug and with PD data available.
Posted
Geometric Mean
Standard Deviation
Fold change
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
ID
Title
Description
OG000
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.
OG001
Part 1 SAD: Cohort 1
HVs received single dose of RO7020531, 3 mg, orally on Day 1.
OG002
Part 1 SAD: Cohort 2
HVs received single dose of RO7020531, 10 mg, orally on Day 1.
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.
Pharmacodynamic population included all participants who had received at least 1 dose of the study drug and with PD data available.
Posted
Geometric Mean
Standard Deviation
Fold change
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
ID
Title
Description
OG000
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.
OG001
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.
OG002
Part 2 Cohort 3
Participants received RO7020531, 170 mg, along with NUC treatment, orally, on Day 1 and QOD for 41 days.
Secondary
Effect of RO7020531 Dosing on ECG Parameters (PR [PQ], QRS, QT, QTcF in Miliseconds [ms]) Using Exposure-response Analysis: SAD and MAD
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.
Posted
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
ID
Title
Description
OG000
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.
OG001
Part 1 SAD: Cohort 1
HVs received single dose of RO7020531, 3 mg, orally on Day 1.
OG002
Part 1 SAD: Cohort 2
HVs received single dose of RO7020531, 10 mg, orally on Day 1.
OG003
Part 1 SAD: Cohort 3
HVs received single dose of RO7020531, 20 mg, orally on Day 1.
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.
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.
Posted
Mean
Standard Deviation
ng/mL
Pre-dose and 2-4 hours post-dose on Day 1, Day 21 and Day 41
ID
Title
Description
OG000
Part 2 Cohorts 1
Participants received RO7020531, 150 mg, along with NUC treatment, orally, on Day 1 and QOD for 41 days.
OG001
Part 2 Cohort 2
Participants were enrolled in Cohort 2 after the internal monitoring committee (IMC) assessed the safety and tolerability data available for Cohort 1. Participants received RO7020531, 150 mg, along with NUC treatment, orally, on Day 1 and QOD for 41 days.
OG002
Part 2 Cohort 3
Participants received RO7020531, 170 mg, along with NUC treatment , orally QOD from Day 1 through to Day 41.
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.
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.
Posted
Number
percentage of participants
From randomization up to Day 8
ID
Title
Description
OG000
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.
OG001
Part 1 SAD: Cohort 1
HVs received single dose of RO7020531, 3 mg, orally on Day 1.
OG002
Part 1 SAD: Cohort 2
HVs received single dose of RO7020531, 10 mg, orally on Day 1.
OG003
Part 1 SAD: Cohort 3
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.
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.
Posted
Number
percentage of participants
From randomization up to Day 20
ID
Title
Description
OG000
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.
OG001
Part 1 MAD: Cohort 1
HVs received RO7020531, 100 mg, orally, on Day 1 and QOD for 13 days.
OG002
Part 1 MAD: Cohort 2
HVs received RO7020531, 140 mg, orally, on Day 1 and QOD for 13 days.
OG003
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.
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.
Posted
Number
percentage of participants
From randomization up to Week 12
ID
Title
Description
OG000
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.
OG001
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.
OG002
Part 2: Cohort 3
Participants received RO7020531, 170 mg, along with NUC treatment, orally, on Day 1 and QOD for 41 days.
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.
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.
Posted
Number
percentage of participants
From randomization up to Day 8
ID
Title
Description
OG000
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.
OG001
Part 1 SAD: Cohort 1
HVs received single dose of RO7020531, 3 mg, orally on Day 1.
OG002
Part 1 SAD: Cohort 2
HVs received single dose of RO7020531, 10 mg, orally on Day 1.
OG003
Part 1 SAD: Cohort 3
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.
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.
Posted
Number
percentage of participants
From randomization up to Day 20
ID
Title
Description
OG000
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.
OG001
Part 1 MAD: Cohort 1
HVs received RO7020531, 100 mg, orally, on Day 1 and QOD for 13 days.
OG002
Part 1 MAD: Cohort 2
HVs received RO7020531, 140 mg, orally, on Day 1 and QOD for 13 days.
OG003
Part 1 MAD: Cohort 3
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.
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.
Posted
Number
percentage of participants
From randomization up to Week 12
ID
Title
Description
OG000
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.
OG001
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.
OG002
Part 2: Cohort 3
Participants received RO7020531, 170 mg, along with NUC treatment, orally, on Day 1 and QOD for 41 days.
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).
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.
Posted
Number
percentage of participants
From randomization up to Day 8
ID
Title
Description
OG000
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.
OG001
Part 1 SAD: Cohort 1
HVs received single dose of RO7020531, 3 mg, orally on Day 1.
OG002
Part 1 SAD: Cohort 2
HVs received single dose of RO7020531, 10 mg, orally on Day 1.
OG003
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).
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.
Posted
Number
percentage of participants
From randomization up to Day 20
ID
Title
Description
OG000
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.
OG001
Part 1 MAD: Cohort 1
HVs received RO7020531, 100 mg, orally, on Day 1 and QOD for 13 days.
OG002
Part 1 MAD: Cohort 2
HVs received RO7020531, 140 mg, orally, on Day 1 and QOD for 13 days.
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).
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.
Posted
Number
percentage of participants
From randomization up to Week 12
ID
Title
Description
OG000
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.
OG001
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.
OG002
Part 2: Cohort 3
Time Frame
From Randomization to End of Study (up to 4.5 years)
Description
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
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.
0
16
0
16
5
16
EG001
Part 1 SAD: Cohort 1
HVs received single dose of RO7020531, 3 mg, orally on Day 1.
0
8
0
8
2
8
EG002
Part 1 SAD: Cohort 2
HVs received single dose of RO7020531, 10 mg, orally on Day 1.
0
8
0
8
4
8
EG003
Part 1 SAD: Cohort 3
HVs received single dose of RO7020531, 20 mg, orally on Day 1.
0
8
0
8
2
8
EG004
Part 1 SAD: Cohort 4
HVs received single dose of RO7020531, 40 mg, orally on Day 1.
0
8
0
8
2
8
EG005
Part 1 SAD: Cohort 5
HVs received single dose of RO7020531, 60 mg, orally on Day 1.
0
8
0
8
2
8
EG006
Part 1 SAD: Cohort 6
HVs received single dose of RO7020531, 100 mg, orally on Day 1.
0
8
0
8
2
8
EG007
Part 1 SAD: Cohort 7
HVs received single dose of RO7020531, 140 mg, orally on Day 1.
0
8
0
8
2
8
EG008
Part 1 SAD: Cohort 8
HVs received single dose of RO7020531, 170 mg, orally on Day 1.
0
8
0
8
3
8
EG009
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.
0
6
0
6
5
6
EG010
Part 1 MAD: Cohort 1
HVs received RO7020531, 100 mg, orally, on Day 1 and QOD for 13 days.
0
8
0
8
6
8
EG011
Part 1 MAD: Cohort 2
HVs received RO7020531, 140 mg, orally, on Day 1 and QOD for 13 days.
0
8
0
8
7
8
EG012
Part 1 MAD: Cohort 3
HVs received RO7020531, 170 mg, orally, on Day 1 and QOD for 13 days.
0
8
0
8
7
8
EG013
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.
0
6
0
6
3
6
EG014
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.
0
16
0
16
11
16
EG015
Part 2: Cohort 3
Participants received RO7020531, 170 mg, along with NUC treatment, orally, on Day 1 and QOD for 41 days.
0
8
0
8
6
8
EG016
Part 2 Cohort 4: Placebo
Treatment naive participants received RO7020531 matching placebo, orally, on Day 1 and QOD for 41 days.
0
5
0
5
3
5
EG017
Part 2: Cohort 4
Treatment naive participants received RO7020531, 150 mg, orally, on Day 1 and QOD for 41 days.
0
15
1
15
12
15
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Influenza like illness
General disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected8 at risk
EG0110 events0 affected8 at risk
EG0120 events0 affected8 at risk
EG0130 events0 affected6 at risk
EG0140 events0 affected16 at risk
EG0150 events0 affected8 at risk
EG0160 events0 affected5 at risk
EG0171 events1 affected15 at risk
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Leukopenia
Blood and lymphatic system disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected8 at risk
EG0110 events0 affected8 at risk
EG0120 events0 affected8 at risk
EG0130 events0 affected6 at risk
EG0141 events1 affected16 at risk
EG0150 events0 affected8 at risk
EG0160 events0 affected5 at risk
EG0171 events1 affected15 at risk
Lymphopenia
Blood and lymphatic system disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Palpitations
Cardiac disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Ventricular extrasystoles
Cardiac disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Cerumen impaction
Ear and labyrinth disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Chalazion
Eye disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Conjunctival hyperaemia
Eye disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Abdominal tenderness
Gastrointestinal disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA version 24.0
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Gastroesophageal reflux disease
Gastrointestinal disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected8 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected8 at risk
EG003
Catheter site bruise
General disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Catheter site erythema
General disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Catheter site inflammation
General disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Catheter site pain
General disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Catheter site phlebitis
General disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Chest pain
General disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Chills
General disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Fatigue
General disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected8 at risk
EG003
Inflammation
General disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Influenza like illness
General disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Malaise
General disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Peripheral swelling
General disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Polyp
General disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Pyrexia
General disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected8 at risk
EG003
Thirst
General disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Vessel puncture site bruise
General disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Rhinitis
Infections and infestations
MedDRA version 24.0
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Viral infection
Infections and infestations
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Burns second degree
Injury, poisoning and procedural complications
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Muscle strain
Injury, poisoning and procedural complications
MedDRA version 24.0
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Road traffic accident
Injury, poisoning and procedural complications
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Skin abrasion
Injury, poisoning and procedural complications
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Sunburn
Injury, poisoning and procedural complications
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected8 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Weight decreased
Investigations
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Musculoskeletal discomfort
Musculoskeletal and connective tissue disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA version 24.0
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Burning sensation
Nervous system disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Dizziness
Nervous system disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Dizziness postural
Nervous system disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Headache
Nervous system disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected8 at risk
EG0022 events2 affected8 at risk
EG003
Lethargy
Nervous system disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Memory impairment
Nervous system disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Presyncope
Nervous system disorders
MedDRA version 24.0
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Tremor
Nervous system disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Affect lability
Psychiatric disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Depressed mood
Psychiatric disorders
MedDRA version 24.0
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Premenstrual pain
Reproductive system and breast disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Dermatitis contact
Skin and subcutaneous tissue disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Erythema ab igne
Skin and subcutaneous tissue disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Papule
Skin and subcutaneous tissue disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Rash macular
Skin and subcutaneous tissue disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Rash papular
Skin and subcutaneous tissue disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Rash pruritic
Skin and subcutaneous tissue disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Skin discolouration
Skin and subcutaneous tissue disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Circulatory collapse
Vascular disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Peripheral coldness
Vascular disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.