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

Vir Biotechnology, Inc.113 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

113

Conditions

Chronic Hepatitis B

Interventions

VIR-3434BIOLOGICAL

VIR-3434 given by subcutaneous injection or intravenous infusion.

PlaceboOTHER

Sterile normal saline (0.9% NaCl) given by subcutaneous injection or intravenous infusion.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Healthy Volunteers: Inclusion Criteria: * Male or female age 18 - 55 * Weight 40-125 kg Exclusion Criteria: * 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 Exclusion Criteria: * Any clinically significant chronic or acute medical condition that makes the participant unsuitable for participation * Significant fibrosis or cirrhosis * History or evidence of drug or alcohol abuse * History of chronic liver disease from any cause other than chronic HBV infection * History of hepatic decompensation * History of anaphylaxis * History of allergic reactions to monoclonal antibodies or antibody fragments * History of immune complex disease * Active infection with HIV, HCV or hepatitis Delta virus

Locations (24)

Investigative Site

Essen, Germany

Investigative Site

Frankfurt, Germany

Outcomes

Primary Outcomes

Number of Participants With Treatment-emergent Adverse Events (TEAEs)

Time frame: Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D

Number of Participants With Clinical Laboratory Abnormalities

Time frame: Up to 280 days post-dose

Secondary Outcomes

Cmax

VIR-3434 Maximum Concentration in Serum

Time frame: Parts B-D: pre-dose and 1, 4, 6, 24 hours, 3, 7, 10, 14, 28, 56, 84, 112, 168, 224, 280 days post-dose

Tmax

VIR-3434 time of Cmax in Serum

Time frame: Part A: pre-dose and 1, 4, 6, 24 hours, 3, 7, 14, 28, 56, 84, 126, 168 days post-dose; Parts B-D: pre-dose and 1, 4, 6, 24 hours, 3, 7, 10, 14, 28, 56, 84, 112, 168, 224, 280 days post-dose

AUClast

VIR-3434 under the curve from time 0 to last measurable Time

Time frame: Parts B-D: pre-dose and 1, 4, 6, 24 hours, 3, 7, 10, 14, 28, 56, 84, 112, 168, 224, 280 days post-dose

t1/2

VIR-3434 apparent Elimination Half-life (t1/2) in serum

Vz/F

VIR-3434 Volume of Distribution (SC only)

Data from ClinicalTrials.gov

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