Trial Review

Technical difficulties have been reported by some users of the search function and is being investigated by technical staff. Thank you for your patience and apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04423393




Registration number
NCT04423393
Ethics application status
Date submitted
25/05/2020
Date registered
9/06/2020
Date last updated
19/12/2022

Titles & IDs
Public title
Study of VIR-3434 in Healthy Volunteers and Patients With Chronic Hepatitis B Virus Infection
Scientific title
A Phase 1, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of VIR-3434
Secondary ID [1] 0 0
2019-003837-40
Secondary ID [2] 0 0
VIR-3434-1002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Hepatitis B 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - VIR-3434
Other interventions - Placebo

Experimental: VIR-3434 -

Placebo Comparator: Placebo -


Other interventions: VIR-3434
VIR-3434 given by subcutaneous injection or intravenous infusion.

Other interventions: Placebo
Sterile normal saline (0.9% NaCl) given by subcutaneous injection or intravenous infusion.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of treatment-emergent adverse events (TEAEs)
Timepoint [1] 0 0
Up to 280 days post-dose
Primary outcome [2] 0 0
Clinical assessment of changes in physical examinations
Timepoint [2] 0 0
Up to 280 days post-dose
Primary outcome [3] 0 0
Clinical assessment and quantification of changes in vital signs: blood pressure
Timepoint [3] 0 0
Up to 280 days post-dose
Primary outcome [4] 0 0
Clinical assessment and quantification of changes in vital signs: pulse rate
Timepoint [4] 0 0
Up to 280 days post-dose
Primary outcome [5] 0 0
Clinical assessment and quantification of changes in vital signs: temperature
Timepoint [5] 0 0
Up to 280 days post-dose
Primary outcome [6] 0 0
Clinical assessment and quantification of changes in vital signs: respiratory rate
Timepoint [6] 0 0
Up to 280 days post-dose
Primary outcome [7] 0 0
Proportion of subjects with abnormalities in ECGs
Timepoint [7] 0 0
Up to 280 days post-dose
Primary outcome [8] 0 0
Clinical assessment and quantification of changes in liver function tests
Timepoint [8] 0 0
Up to 280 days post-dose
Primary outcome [9] 0 0
Clinical assessment and quantification of changes in serum chemistry parameters
Timepoint [9] 0 0
Up to 280 days post-dose
Primary outcome [10] 0 0
Clinical assessment and quantification of changes in hematology parameters
Timepoint [10] 0 0
Up to 280 days post-dose
Primary outcome [11] 0 0
Clinical assessment and quantification of changes in coagulation parameters
Timepoint [11] 0 0
Up to 280 days post-dose
Primary outcome [12] 0 0
Clinical assessment and quantification of changes in urinalysis parameters
Timepoint [12] 0 0
Up to 280 days post-dose
Primary outcome [13] 0 0
Clinical assessment and quantification of changes in complement
Timepoint [13] 0 0
Up to 280 days post-dose
Primary outcome [14] 0 0
Clinical assessment of changes in local tolerability using a numeric scoring tool that is based on FDA and DAIDs injection site reaction grading scales
Timepoint [14] 0 0
Up to 280 days post-dose
Secondary outcome [1] 0 0
Cmax
Timepoint [1] 0 0
Up to 280 days post-dose
Secondary outcome [2] 0 0
Clast
Timepoint [2] 0 0
Up to 280 days post-dose
Secondary outcome [3] 0 0
Tmax
Timepoint [3] 0 0
Up to 280 days post-dose
Secondary outcome [4] 0 0
Tlast
Timepoint [4] 0 0
Up to 280 days post-dose
Secondary outcome [5] 0 0
AUCinf
Timepoint [5] 0 0
Up to 280 days post-dose
Secondary outcome [6] 0 0
AUClast
Timepoint [6] 0 0
Up to 280 days post-dose
Secondary outcome [7] 0 0
%AUCexp
Timepoint [7] 0 0
Up to 280 days post-dose
Secondary outcome [8] 0 0
t1/2
Timepoint [8] 0 0
Up to 280 days post-dose
Secondary outcome [9] 0 0
?z
Timepoint [9] 0 0
Up to 280 days post-dose
Secondary outcome [10] 0 0
Vz (IV only)
Timepoint [10] 0 0
Up to 280 days post-dose
Secondary outcome [11] 0 0
CL (IV only)
Timepoint [11] 0 0
Up to 280 days post-dose
Secondary outcome [12] 0 0
Vz/F (SC only)
Timepoint [12] 0 0
Up to 280 days post-dose
Secondary outcome [13] 0 0
CL/F (SC only)
Timepoint [13] 0 0
Up to 280 days post-dose
Secondary outcome [14] 0 0
Incidence of ADA to VIR-3434
Timepoint [14] 0 0
Up to 280 days post-dose
Secondary outcome [15] 0 0
Titers of ADA to VIR-3434
Timepoint [15] 0 0
Up to 280 days post-dose
Secondary outcome [16] 0 0
Maximum reduction of serum HBsAg from baseline (Day 1 predose)
Timepoint [16] 0 0
Up to 280 days post-dose
Secondary outcome [17] 0 0
Part D only: maximum change of HBV DNA from baseline (Day 1 predose)
Timepoint [17] 0 0
Up to 280 days post-dose

Eligibility
Key inclusion criteria
Healthy Volunteers:



- Male or female age 18 - 55

- Weight 40-125 kg
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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



- 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/05/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
25/11/2022
Sample size
Target
Accrual to date
Final
113
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Germany
State/province [1] 0 0
Essen
Country [2] 0 0
Germany
State/province [2] 0 0
Frankfurt
Country [3] 0 0
Germany
State/province [3] 0 0
Hannover
Country [4] 0 0
Germany
State/province [4] 0 0
Leipzig
Country [5] 0 0
Germany
State/province [5] 0 0
Mainz
Country [6] 0 0
Germany
State/province [6] 0 0
Mannheim
Country [7] 0 0
Hong Kong
State/province [7] 0 0
Hong Kong
Country [8] 0 0
Korea, Republic of
State/province [8] 0 0
Busan
Country [9] 0 0
Korea, Republic of
State/province [9] 0 0
Seoul
Country [10] 0 0
New Zealand
State/province [10] 0 0
Auckland
Country [11] 0 0
New Zealand
State/province [11] 0 0
Havelock North
Country [12] 0 0
New Zealand
State/province [12] 0 0
Tauranga
Country [13] 0 0
New Zealand
State/province [13] 0 0
Wellington
Country [14] 0 0
Romania
State/province [14] 0 0
Bucharest
Country [15] 0 0
Singapore
State/province [15] 0 0
Singapore
Country [16] 0 0
United Kingdom
State/province [16] 0 0
Birmingham
Country [17] 0 0
United Kingdom
State/province [17] 0 0
London
Country [18] 0 0
United Kingdom
State/province [18] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Vir Biotechnology, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT04423393
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries