NCT03672188

Study of VIR-2218 in Healthy Subjects and Patients With Chronic Hepatitis B

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: Vir Biotechnology, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Chronic Hepatitis B

Interventions

Type	Name	Description
DRUG	VIR-2218	VIR-2218 given by subcutaneous injection
DRUG	Placebo	Sterile normal saline (0.9% NaCl) given by subcutaneous injection

Timeline

• Start date: 2018-11-14
• Primary completion: 2020-09-03
• Completion: 2020-09-03
• First posted: 2018-09-14
• Last updated: 2021-12-13
• Results posted: 2021-12-13

Locations

14 sites across 5 countries: Australia, Hong Kong, New Zealand, South Korea, Thailand

Regulatory

• FDA-regulated drug study