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

Chronic Hepatitis B Clinical Trial

Official title:

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

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
• 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
• 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

Related Conditions & MeSH terms

• Chronic Hepatitis B
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

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