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Completed

NCT Number: NCT04423393

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

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).

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Key information

Conditions

Chronic Hepatitis B Blood-Borne Infections Chronic Disease Communicable Diseases DNA Virus Infections Digestive System Diseases Disease Attributes Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis B, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Investigative Site, Essen, Germany

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VIR-3434

Biological

VIR-3434 given by subcutaneous injection or intravenous infusion.

Placebo

Other

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

Primary outcomes

  1. 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

  2. Number of Participants With Clinical Laboratory Abnormalities

    Time frame: Up to 280 days post-dose

Secondary outcomes

  1. Cmax

    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

    VIR-3434 Maximum Concentration in Serum

  2. Tmax

    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

    VIR-3434 time of Cmax in Serum

  3. AUClast

    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

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

  4. t1/2

    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

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

  5. Vz/F

    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

    VIR-3434 Volume of Distribution (SC only)

  6. Vz

    Time frame: Part A: pre-dose and 1, 4, 6, 24 hours, 3, 7, 14, 28, 56, 84, 126, 168 days post-dose

    VIR-3434 Volume of Distribution (IV only)

  7. CL/F

    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

    VIR-3434 Apparent serum clearance (SC only)

  8. CL

    Time frame: Part A: pre-dose and 1, 4, 6, 24 hours, 3, 7, 14, 28, 56, 84, 126, 168 days post-dose

    VIR-3434 Apparent serum clearance (IV only)

  9. Number of Participants With ADA to VIR-3434

    Time frame: Part A: Up to 168 days post-dose. Parts B-D: Up to 280 days post-dose

    Evaluate the immunogenicity of VIR-3434

  10. Maximum Reduction of Serum HBsAg From Baseline (Day 1 Predose)

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

    HBsAg reductions at nadir and Week 4

  11. Part D Only: Maximum Change of HBV DNA From Baseline (Day 1 Predose)

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

    HBV DNA reductions at nadir and Week 4

  12. Titers (if Applicable) of ADA to VIR-3434

    Time frame: Part A: Up to 168 days post-dose. Parts B-D: Up to 280 days post-dose

    Evaluate the immunogenicity of VIR-3434

  13. Cmax

    Time frame: Part A: pre-dose and 1, 4, 6, 24 hours, 3, 7, 14, 28, 56, 84, 126, 168 days post-dose

    VIR-3434 Maximum Concentration in Serum

  14. AUClast

    Time frame: Part A: pre-dose and 1, 4, 6, 24 hours, 3, 7, 14, 28, 56, 84, 126, 168 days post-dose

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

Sponsors and collaborators

Lead sponsor

Vir Biotechnology, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jun 9, 2020
Registry last updated
Oct 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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