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

NCT04423393 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 113

Last updated 2024-10-08

Study results available
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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

Interventions

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.

Sponsors & Collaborators

  • Vir Biotechnology, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-05-26
Primary Completion
2022-10-24
Completion
2022-11-25
FDA Drug
Yes

Countries

  • Germany
  • Hong Kong
  • New Zealand
  • Romania
  • Singapore
  • South Korea
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04423393 on ClinicalTrials.gov