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

V

Vir Biotechnology

Status and phase

Completed
Phase 1

Conditions

Chronic Hepatitis B

Treatments

Other: Placebo
Biological: VIR-3434

Study type

Interventional

Funder types

Industry

Identifiers

NCT04423393
VIR-3434-1002
2019-003837-40 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment

113 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

113 participants in 2 patient groups, including a placebo group

VIR-3434
Experimental group
Treatment:
Biological: VIR-3434
Placebo
Placebo Comparator group
Treatment:
Other: Placebo

Trial contacts and locations

23

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Data sourced from clinicaltrials.gov

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