Clinical trial

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

Name

VIR-3434-1002

Description

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).

Trial arms

Trial start

2020-05-26

Estimated PCD

2022-10-24

Trial end

2022-11-25

Status

Completed

Phase

Early phase I

Treatment

VIR-3434

VIR-3434 given by subcutaneous injection or intravenous infusion.

Arms:

VIR-3434

Placebo

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

Arms:

Placebo

Size

113

Primary endpoint

Incidence of treatment-emergent adverse events (TEAEs)

Up to 280 days post-dose

Clinical assessment of changes in physical examinations

Up to 280 days post-dose

Clinical assessment and quantification of changes in vital signs: blood pressure

Up to 280 days post-dose

Clinical assessment and quantification of changes in vital signs: pulse rate

Up to 280 days post-dose

Clinical assessment and quantification of changes in vital signs: temperature

Up to 280 days post-dose

Clinical assessment and quantification of changes in vital signs: respiratory rate

Up to 280 days post-dose

Proportion of subjects with abnormalities in ECGs

Up to 280 days post-dose

Clinical assessment and quantification of changes in liver function tests

Up to 280 days post-dose

Clinical assessment and quantification of changes in serum chemistry parameters

Up to 280 days post-dose

Clinical assessment and quantification of changes in hematology parameters

Up to 280 days post-dose

Clinical assessment and quantification of changes in coagulation parameters

Up to 280 days post-dose

Clinical assessment and quantification of changes in urinalysis parameters

Up to 280 days post-dose

Clinical assessment and quantification of changes in complement

Up to 280 days post-dose

Clinical assessment of changes in local tolerability using a numeric scoring tool that is based on FDA and DAIDs injection site reaction grading scales

Up to 280 days post-dose

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 113, 'type': 'ACTUAL'}}

Updated at

2022-12-19

1 organization

1 product

1 indication

Organization

Vir Biotechnology

Product

VIR-3434

Indication

Chronic Hepatitis B