CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 82 enrolled
Drug / intervention
VIR-2218 +1 moredrug
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/NCT03672188
NCT03672188Phase 2Completed
CompareCT.gov

A Phase 1/2, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of VIR-2218

Vir Biotechnology, Inc.·interventional·Posted Sep 14, 2018·Updated Dec 13, 2021

In Brief

A Phase 2 clinical trial evaluating VIR-2218 and Placebo for Chronic Hepatitis B. Completed, enrolled 82 participants across 14 sites in 5 countries.

Detailed Summary

This is a phase 1/2 study in which healthy adult subjects and subjects with chronic hepatitis B virus (HBV) infection will receive VIR-2218 or placebo and will be assessed for safety, tolerability, pharmacokinetics, and antiviral activity (only in subjects with chronic HBV). In the single ascending dose (SAD) part, Part A, healthy adult subjects will receive one dose of VIR-2218 or placebo, administered subcutaneously (SC). In the multiple ascending dose (MAD) parts, Part B \& Part C, subjects with chronic HBV infection will receive two doses of VIR-2218 or placebo every 4 weeks administered SC.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Hepatitis B
CountriesAustralia, Hong Kong, New Zealand, South Korea, Thailand
CollaboratorsAlnylam Pharmaceuticals

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedSep 14, 2018
Enrollment StartNov 14, 2018
Primary CompletionSep 3, 2020
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 7.8 years ago

Interventions

VIR-2218drug

VIR-2218 given by subcutaneous injection

Placebodrug

Sterile normal saline (0.9% NaCl) given by subcutaneous injection