Study of VIR-2218 in Patients With Chronic Hepatitis B in Mainland China

Brii Biosciences

Status and phase: Completed; Phase 2

Conditions: Hepatitis B, Chronic

Treatments: Drug: VIR-2218; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04507269

VIR-2218-1005

Details and patient eligibility

About

This study is to evaluate the safety, pharmacokinetics characteristics, and antiviral activities of multiple doses of VIR-2218 in adults with chronic HBV infection in mainland China.

Enrollment: 21 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female age 18 - 65;
• Weight ≥ 40 kg to ≤ 125 kg;
• Chronic HBV infection as defined by a positive serum HBsAg for ≥ 6 months;

Exclusion criteria

• Any clinically significant chronic or acute medical condition that makes the volunteer unsuitable for participation;
• Significant fibrosis or cirrhosis;
• History or evidence of drug or alcohol abuse;
• History of intolerance to SC injection;
• History of chronic liver disease from any cause other than chronic HBV infection;
• History of hepatic decompensation;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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21 participants in 2 patient groups, including a placebo group

VIR-2218

Experimental group

Description:

Drug: VIR-2218 VIR-2218 given by subcutaneous injection

Treatment:

Drug: VIR-2218

Placebo

Placebo Comparator group

Description:

Drug: Placebo Saline given by subcutaneous injection

Treatment:

Drug: Placebo