CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 113 enrolled
Drug / intervention
VIR-3434 +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04423393
NCT04423393Phase 1Completed

A Phase 1, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of VIR-3434

Vir Biotechnology, Inc.·interventional·Posted Jun 9, 2020·Updated Oct 8, 2024

In Brief

A Phase 1 clinical trial evaluating VIR-3434 and Placebo for Chronic Hepatitis B. Completed, enrolled 113 participants across 24 sites in 7 countries.

Detailed Summary

This is a Phase 1 study in which healthy volunteers and participants with chronic HBV infection will receive VIR-3434 or placebo and will be assessed for safety, tolerability, pharmacokinetics (PK), and antiviral activity (only in participants with chronic HBV infection).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesGermany, Hong Kong, New Zealand, Romania, Singapore, South Korea, United Kingdom
Collaborators--

Timeline

Phase 1CompletedFinished
202120222023202420252026
First PostedJun 9, 2020
Enrollment StartMay 26, 2020
Primary CompletionOct 24, 2022
Study CompletionNov 25, 2022
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 6.1 years ago

Interventions

VIR-3434biological

VIR-3434 given by subcutaneous injection or intravenous infusion.

Placeboother

Sterile normal saline (0.9% NaCl) given by subcutaneous injection or intravenous infusion.