NCT04423393

Brief Summary

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 Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
113

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started May 2020

Typical duration for phase_1

Geographic Reach
7 countries

24 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 25, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

May 26, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 9, 2020

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 24, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 25, 2022

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

October 8, 2024

Completed
Last Updated

October 8, 2024

Status Verified

September 1, 2024

Enrollment Period

2.4 years

First QC Date

May 25, 2020

Results QC Date

October 20, 2023

Last Update Submit

September 27, 2024

Conditions

Chronic Hepatitis B

Keywords

Hepatitis B VirusChronic Hepatitis BHBVHepatitis

Outcome Measures

Primary Outcomes (2)

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

    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

    Up to 280 days post-dose

Secondary Outcomes (14)

  • Cmax

    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

    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

    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

    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

  • Vz/F

    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

  • +9 more secondary outcomes

Study Arms (2)

VIR-3434

EXPERIMENTAL
Biological: VIR-3434

Placebo

PLACEBO COMPARATOR
Other: Placebo

Interventions

VIR-3434BIOLOGICAL

VIR-3434 given by subcutaneous injection or intravenous infusion.

VIR-3434
PlaceboOTHER

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

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female age 18 - 55
  • Weight 40-125 kg

You may not qualify if:

  • 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:
  • Male or female age 18 - 65
  • Weight 40-125 kg
  • Chronic HBV infection for \>/= 6 months
  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (24)

Investigative Site

Essen, 45147, Germany

Location

Investigative Site

Frankfurt, 60590, Germany

Location

Investigative Site

Hanover, 30625, Germany

Location

Investigative Site

Leipzig, 04103, Germany

Location

Investigative Site

Mainz, 55131, Germany

Location

Investigative Site

Mannheim, 68167, Germany

Location

Investigative Site

Ulm, 89081, Germany

Location

Investigative Site

Hong Kong, Hong Kong

Location

Investigative Site

Auckland, 1010, New Zealand

Location

Investigative Site

Havelock North, 4130, New Zealand

Location

Investigative Site

Newtown, 6021, New Zealand

Location

Investigative Site

Tauranga, 3110, New Zealand

Location

Investigative Site

Bucharest, Romania

Location

Investigative Site

Singapore, 169608, Singapore

Location

Investigative Site

Singapore, 529889, Singapore

Location

Investigative Site

Busan, 47392, South Korea

Location

Investigative Site

Busan, 49241, South Korea

Location

Investigative Site

Seoul, 02841, South Korea

Location

Investigative Site

Seoul, 03080, South Korea

Location

Investigative Site

Seoul, 05505, South Korea

Location

Investigative Site

Seoul, 06273, South Korea

Location

Investigative Site

Birmingham, B15 2TT, United Kingdom

Location

Investigative Site

London, E1 2EF, United Kingdom

Location

Investigative Site

Manchester, M8 5RB, United Kingdom

Location

Related Publications (1)

  • Vincenzetti L, Wong R, Marzi R, Guarino B, Stefanutti E, Gupta SV, Rosen LE, Belnap DM, Wang L, Chen YP, di Iulio J, Momin A, Tracy KE, Deshpande S, Errico JM, Giovannoni F, Sprugasci N, Peter A, Seu L, Cloutier D, Tay CH, Snell G, Czudnochowski N, Lempp FA, Havenar-Daughton C, Benigni F, Lanzavecchia A, Agarwal K, Yuen MF, Wedemeyer H, Gane E, Arvin A, Corti D, Schmid MA. Engineered monoclonal antibody tobevibart enhances HBsAg capture by Fc receptor-positive cells and activates HBV-specific T cells. J Hepatol. 2026 Jan;84(1):62-73. doi: 10.1016/j.jhep.2025.08.016. Epub 2025 Aug 27.

    PMID: 40882923DERIVED

MeSH Terms

Conditions

Hepatitis B, ChronicHepatitis BHepatitis

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitis, ChronicLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Study Inquiry
Organization
Vir Biotechnology, Inc.
clinicaltrials@vir.bio
(415) 906-4324

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2020

First Posted

June 9, 2020

Study Start

May 26, 2020

Primary Completion

October 24, 2022

Study Completion

November 25, 2022

Last Updated

October 8, 2024

Results First Posted

October 8, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)RO(1)DE(7)KR(6)NZ(4)GB(3)SG(2)