Status:
COMPLETED
Study of VIR-3434 in Healthy Volunteers and Patients With Chronic Hepatitis B Virus Infection
Lead Sponsor:
Vir Biotechnology, Inc.
Conditions:
Chronic Hepatitis B
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief 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), a...
Eligibility Criteria
Inclusion
- Healthy Volunteers:
- Male or female age 18 - 55
- Weight 40-125 kg
Exclusion
- Any clinically significant chronic or acute medical condition that makes the volunteer unsuitable for participation
- History or evidence of drug or alcohol abuse
- History of allergic reactions to monoclonal antibodies or antibody fragments
- History of anaphylaxis
- CHB Patients:
- Inclusion Criteria:
- Male or female age 18 - 65
- Weight 40-125 kg
- Chronic HBV infection for \>/= 6 months
Key Trial Info
Start Date :
May 26 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 25 2022
Estimated Enrollment :
113 Patients enrolled
Trial Details
Trial ID
NCT04423393
Start Date
May 26 2020
End Date
November 25 2022
Last Update
October 8 2024
Active Locations (24)
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1
Investigative Site
Essen, Germany, 45147
2
Investigative Site
Frankfurt, Germany, 60590
3
Investigative Site
Hanover, Germany, 30625
4
Investigative Site
Leipzig, Germany, 04103