Last updated on March 2019

A Study to Investigate the Safety Tolerability Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of RO7049389 in Healthy Volunteers and Chronic Hepatitis B Virus (HBV) Infected Participants

Brief description of study

This study is sponsor-open, investigator-blinded, participant-blinded, randomized, placebo-controlled, single-ascending dose (SAD) and multiple-ascending dose (MAD) study that will evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of RO7049389 following oral administration in healthy volunteers and chronic HBV infected participants. The effect of food on the PK of RO7049389 and the effect of multiple dosing of RO7049389 on the PK of a single oral microdose of midazolam will be evaluated. The study will be conducted in two parts: Part 1 (1a [SAD cohort], 1b [Food-effect SAD cohort], 1c [MAD Cohort]) in healthy volunteers and Part 2 (Proof of mechanism [POM]) in chronic HBV infected participants.

Clinical Study Identifier: NCT02952924

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Royal Melbourne Hospital

Parkville, Australia
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