Hepatitis B, Chronic
Conditions
Brief summary
This is a multiple-center, randomized, double-blind, placebo-controlled, single-ascending dose and multiple-ascending dose, adaptive parallel study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of RO7020322 following oral administration in healthy participants and chronic hepatitis B patients.
Interventions
OTHERMatching Placebo
Oral dosing with placebo capsules to match RO7020322.
DRUGRO7020322
Adaptive oral dosing with RO7020322 capsules, starting at 1 mg daily, with ascending or adjusted dosing based on the results of previous dosing.
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Healthy Participants' Inclusion Criteria: * A Body Mass Index (BMI) between 18 to 30 kg/m\^2, inclusive, and a body weight of at least 50 kg * Males must agree to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agree to refrain from donating sperm during the study * Women should be of non-childbearing potential * Able to comply with study restrictions * Non-smoker (nor tobacco-containing products) for at least 90 days prior to dosing on Day 1 and agreeing not to smoke during the study Chronic Hepatitis B-Infected Participants' Inclusion Criteria: * Chronic hepatitis B infection * A BMI between 18 to 32 kg/m\^2, inclusive * Positive test for HBsAg for more than 6 months prior to randomization * On entecavir or tenofovir treatment for at least 6 months prior to randomization and remaining on stable treatment during the study * Liver biopsy, fibroscan® or equivalent test obtained within the past 6 months demonstrating liver disease consistent with chronic hepatitis B (HBV) infection without evidence of bridging fibrosis or cirrhosis * Males must agree to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agree to refrain from donating sperm during the study * Women of childbearing potential must agree to remain abstinent (refrain from heterosexual intercourse) or use non-hormonal contraceptive methods that result in a failure rate of \< 1% per year during the treatment period and for at least until the end of the follow-up period
Exclusion criteria
Healthy Participants'
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with adverse events | Up to 8 weeks |
| Intensity of adverse events | Up to 8 weeks |
| Number of participants with clinically significant laboratory abnormalities | Up to 8 weeks |
| Number of participants with clinically significant electrocardiogram (ECG) abnormalities | Up to 8 weeks |
| Number of participants with clinically significant vital signs abnormalities | Up to 8 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Area under the plasma concentration-time curve between time zero (pre-dose) extrapolated to infinity (AUC0-Inf) of RO7020322 | Up to 18 days |
| Apparent clearance (CL/F) of RO7020322 | Up to 18 days |
| Apparent volume (V/F) of RO7020322 | Up to 18 days |
| Plasma concentration of hepatitis B surface antigen (HBsAg) | Up to 8 weeks |
| Area under the plasma concentration-time curve (AUC0-t,ss) of RO7020322 at steady state | Up to 18 days |
| Area under the plasma concentration-time curve (AUC0-t) of RO7020322 on Day 1 | Up to 18 days |
| Apparent terminal phase half-life (t1/2) of RO7020322 | Up to 18 days |
| Maximum observed plasma concentration (Cmax) of RO7020322 | Up to 18 days |
| Time from dosing to Cmax (Tmax) of RO7020322 | Up to 18 days |
| Trough plasma concentrations (Ctrough) of RO7020322 | Up to 18 days |
| Area under the plasma concentration-time curve between time zero (pre-dose) and the time of the last quantifiable concentration (AUClast) of RO7020322 | Up to 18 days |
Countries
Hong Kong, New Zealand, Taiwan
Outcome results
None listed