NCT04423393

Study of VIR-3434 in Healthy Volunteers and Patients With Chronic Hepatitis B Virus Infection

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 113 (actual)
• Sponsor: Vir Biotechnology, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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).

Conditions

• Chronic Hepatitis B

Interventions

Type	Name	Description
BIOLOGICAL	VIR-3434	VIR-3434 given by subcutaneous injection or intravenous infusion.
OTHER	Placebo	Sterile normal saline (0.9% NaCl) given by subcutaneous injection or intravenous infusion.

Timeline

• Start date: 2020-05-26
• Primary completion: 2022-10-24
• Completion: 2022-11-25
• First posted: 2020-06-09
• Last updated: 2024-10-08
• Results posted: 2024-10-08

Locations

24 sites across 7 countries: Germany, Hong Kong, New Zealand, Romania, Singapore, South Korea, United Kingdom

Regulatory

• FDA-regulated drug study