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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04423393
Other study ID # VIR-3434-1002
Secondary ID 2019-003837-40
Status Completed
Phase Phase 1
First received
Last updated
Start date May 26, 2020
Est. completion date November 25, 2022

Study information

Verified date December 2022
Source Vir Biotechnology, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 113
Est. completion date November 25, 2022
Est. primary completion date October 24, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design


Intervention

Biological:
VIR-3434
VIR-3434 given by subcutaneous injection or intravenous infusion.
Other:
Placebo
Sterile normal saline (0.9% NaCl) given by subcutaneous injection or intravenous infusion.

Locations

Country Name City State
Germany Investigative Site Essen
Germany Investigative Site Frankfurt
Germany Investigative Site Hannover
Germany Investigative Site Leipzig
Germany Investigative Site Mainz
Germany Investigative Site Mannheim
Hong Kong Investigative Site Hong Kong
Korea, Republic of Investigative Site Busan
Korea, Republic of Investigative Site Busan
Korea, Republic of Investigative Site Seoul
Korea, Republic of Investigative Site Seoul
Korea, Republic of Investigative Site Seoul
Korea, Republic of Investigative Site Seoul
New Zealand Investigative Site Auckland
New Zealand Investigative Site Havelock North
New Zealand Investigative Site Tauranga
New Zealand Investigative Site Wellington
Romania Investigative Site Bucharest
Singapore Investigative Site Singapore
Singapore Investigative Site Singapore
United Kingdom Investigative Site Birmingham
United Kingdom Investigative Site London
United Kingdom Investigative Site Manchester

Sponsors (1)

Lead Sponsor Collaborator
Vir Biotechnology, Inc.

Countries where clinical trial is conducted

Germany,  Hong Kong,  Korea, Republic of,  New Zealand,  Romania,  Singapore,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Other Assessment of mean changes in HBV RNA levels Up to 280 days post-dose
Other Assessment of mean changes in HBcrAg levels Up to 280 days post-dose
Other Evaluation of host immune responses in peripheral blood, including analysis of circulating biomarkers and cellular immunity Up to 280 days post-dose
Other Analysis and evaluation of host gene expression by RNA-sequencing Up to 280 days post-dose
Other Fc gamma receptor (Fc?R) polymorphisms as determined by genotyping Day 1
Other IgG allotypes as determined by genotyping Day 1
Primary Incidence of treatment-emergent adverse events (TEAEs) Up to 280 days post-dose
Primary Clinical assessment of changes in physical examinations Up to 280 days post-dose
Primary Clinical assessment and quantification of changes in vital signs: blood pressure Up to 280 days post-dose
Primary Clinical assessment and quantification of changes in vital signs: pulse rate Up to 280 days post-dose
Primary Clinical assessment and quantification of changes in vital signs: temperature Up to 280 days post-dose
Primary Clinical assessment and quantification of changes in vital signs: respiratory rate Up to 280 days post-dose
Primary Proportion of subjects with abnormalities in ECGs Up to 280 days post-dose
Primary Clinical assessment and quantification of changes in liver function tests Alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, and bilirubin Up to 280 days post-dose
Primary Clinical assessment and quantification of changes in serum chemistry parameters Albumin, blood urea nitrogen, calcium, carbon dioxide/bicarbonate, chloride, creatine kinase, creatinine, creatinine clearance, gamma glutamyl transferase, glucose, lactate dehydrogenase, potassium, and sodium Up to 280 days post-dose
Primary Clinical assessment and quantification of changes in hematology parameters Bands, basophils, eosinophils, hematocrit, hemoglobin, lymphocytes, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, mean corpuscular volume, monocytes, neutrophils, platelets, red blood cells, and white blood cells Up to 280 days post-dose
Primary Clinical assessment and quantification of changes in coagulation parameters INR and prothrombin time Up to 280 days post-dose
Primary Clinical assessment and quantification of changes in urinalysis parameters Bilirubin, glucose, ketones, leukocytes, nitrite, pH, proteins, red blood cells, specific gravity, and urobilinogen Up to 280 days post-dose
Primary Clinical assessment and quantification of changes in complement C3 and C4 Up to 280 days post-dose
Primary Clinical assessment of changes in local tolerability using a numeric scoring tool that is based on FDA and DAIDs injection site reaction grading scales Up to 280 days post-dose
Secondary Cmax Up to 280 days post-dose
Secondary Clast Up to 280 days post-dose
Secondary Tmax Up to 280 days post-dose
Secondary Tlast Up to 280 days post-dose
Secondary AUCinf Up to 280 days post-dose
Secondary AUClast Up to 280 days post-dose
Secondary %AUCexp Up to 280 days post-dose
Secondary t1/2 Up to 280 days post-dose
Secondary ?z Up to 280 days post-dose
Secondary Vz (IV only) Up to 280 days post-dose
Secondary CL (IV only) Up to 280 days post-dose
Secondary Vz/F (SC only) Up to 280 days post-dose
Secondary CL/F (SC only) Up to 280 days post-dose
Secondary Incidence of ADA to VIR-3434 Up to 280 days post-dose
Secondary Titers of ADA to VIR-3434 Up to 280 days post-dose
Secondary Maximum reduction of serum HBsAg from baseline (Day 1 predose) Up to 280 days post-dose
Secondary Part D only: maximum change of HBV DNA from baseline (Day 1 predose) Up to 280 days post-dose
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