VIR-3434-1002
Research type
Research Study
Full title
A Phase 1, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of VIR-3434
IRAS ID
277305
Contact name
Kaushik Agarwal
Contact email
Sponsor organisation
Vir Biotechnology, Inc.
Eudract number
2019-003837-40
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 1 months, 1 days
Research summary
VIR-3434 is an investigational product that is a half-life extended human IgG1 monoclonal antibody that binds the antigenic loop present in the HBV surface envelope protein (HBsAg) leading to binding and neutralization of viral and subviral particles.
VIR-3434-1002 is a global, multicentre, phase I, randomized, double-blind, placebo-controlled single ascending dose study which will evaluate the safety, tolerability, pharmacokinetics and antiviral activity of VIR-3434. This is a first in human clinical trial using VIR-3434 and currently no other clinical trial is being conducted.
The study will be conducted in up to 3 Parts. Part A will be conducted at a single investigative site in New Zealand, whereas the UK will only participate in Parts B and C only.
Up to 56 adult subjects with HBeAg-negative chronic HBV infection without cirrhosis and with HBsAg < 1000 IU/mL on NRTI therapy for ≥ 2 months will be enrolled in 1 of 7 cohorts in Part B. Of the 7 cohorts, 5 are planned and will evaluate 6 mg, 18 mg, up to 75 mg, up to 300 mg and up to 900 mg of VIR-3434 administered subcutaneously, and 2 are optional (may be dosed at a lower, equivalent, or intermediate dose level relative to the dose levels explored in the planned Part B cohorts).
Part C is optional and may be conducted if VIR-3434 is found to have an acceptable safety and tolerability profile in Part B. Up to 24 adult subjects with chronic HBV infection without cirrhosis and with HBsAg ≥ 1000 IU/mL on NRTI therapy for ≥ 2 months will be enrolled in 1 of 3 optional cohorts.
A Safety Review Committee (SRC) will perform ongoing reviews of safety, tolerability with primary purpose to protect the safety of participating subjects in the above mentioned clinical trial.
REC name
London - City & East Research Ethics Committee
REC reference
20/LO/0255
Date of REC Opinion
3 May 2020
REC opinion
Further Information Favourable Opinion