Clinical trial NCT04423393: Study of VIR-3434 in Healthy Volunteers and Patients With Chronic Hepatitis B Virus Infection
Official title: A Phase 1, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of VIR-3434
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Hepatitis B
Keywords: Hepatitis B Virus
Chronic Hepatitis B
HBV
Hepatitis
Lead sponsor: Vir Biotechnology, Inc.
Sponsor class: INDUSTRY
First posted: 2020-06-09
Enrollment: 113
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
timeFrame: Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
measure: Number of Participants With Clinical Laboratory Abnormalities
timeFrame: Up to 280 days post-dose
Secondary outcomes:
measure: Cmax
timeFrame: 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
measure: Tmax
timeFrame: 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
measure: AUClast
timeFrame: 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
measure: t1/2
timeFrame: 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
measure: Vz/F
timeFrame: 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
measure: Vz
timeFrame: Part A: pre-dose and 1, 4, 6, 24 hours, 3, 7, 14, 28, 56, 84, 126, 168 days post-dose
measure: CL/F
timeFrame: 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
measure: CL
timeFrame: Part A: pre-dose and 1, 4, 6, 24 hours, 3, 7, 14, 28, 56, 84, 126, 168 days post-dose
measure: Number of Participants With ADA to VIR-3434
timeFrame: Part A: Up to 168 days post-dose. Parts B-D: Up to 280 days post-dose
measure: Maximum Reduction of Serum HBsAg From Baseline (Day 1 Predose)
timeFrame: Parts B-D: pre-dose and 1, 3, 7, 10, 14, 28, 56, 84, 112, 168, 224, 280 days post-dose
measure: Part D Only: Maximum Change of HBV DNA From Baseline (Day 1 Predose)
timeFrame: 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
measure: Titers (if Applicable) of ADA to VIR-3434
timeFrame: Part A: Up to 168 days post-dose. Parts B-D: Up to 280 days post-dose
measure: Cmax
timeFrame: Part A: pre-dose and 1, 4, 6, 24 hours, 3, 7, 14, 28, 56, 84, 126, 168 days post-dose
measure: AUClast
timeFrame: Part A: pre-dose and 1, 4, 6, 24 hours, 3, 7, 14, 28, 56, 84, 126, 168 days post-dose
Other outcomes:
Locations:
city: Essen
country: Germany
facility: Investigative Site
city: Frankfurt
country: Germany
facility: Investigative Site
city: Hannover
country: Germany
facility: Investigative Site
city: Leipzig
country: Germany
facility: Investigative Site
city: Mainz
country: Germany
facility: Investigative Site
city: Mannheim
country: Germany
facility: Investigative Site
city: Ulm
country: Germany
facility: Investigative Site
city: Hong Kong
country: Hong Kong
facility: Investigative Site
city: Busan
country: Korea, Republic of
facility: Investigative Site
city: Busan
country: Korea, Republic of
facility: Investigative Site
city: Seoul
country: Korea, Republic of
facility: Investigative Site
city: Seoul
country: Korea, Republic of
facility: Investigative Site
city: Seoul
country: Korea, Republic of
facility: Investigative Site
city: Seoul
country: Korea, Republic of
facility: Investigative Site
city: Auckland
country: New Zealand
facility: Investigative Site
city: Havelock North
country: New Zealand
facility: Investigative Site
city: Newtown
country: New Zealand
facility: Investigative Site
city: Tauranga
country: New Zealand
facility: Investigative Site
city: Bucharest
country: Romania
facility: Investigative Site
city: Singapore
country: Singapore
facility: Investigative Site
city: Singapore
country: Singapore
facility: Investigative Site
city: Birmingham
country: United Kingdom
facility: Investigative Site
city: London
country: United Kingdom
facility: Investigative Site
city: Manchester
country: United Kingdom
facility: Investigative Site
Study officials:
References: