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

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 2 Randomized, Placebo-Controlled Study in Mainland China to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of VIR-2218

Conditions
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Hepatitis B, Chronic

Intervention / Treatment
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* Drug: VIR-2218
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VIR-2218<br>Drug: VIR-2218 VIR-2218 given by subcutaneous injection | Drug: VIR-2218<br>* VIR-2218 given by subcutaneous injection<br>|
| Placebo Comparator: Placebo<br>Drug: Placebo Saline given by subcutaneous injection | Drug: Placebo<br>* Saline given by subcutaneous injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with treatment-emergent adverse events as assessed by CTCAE v5.0 |  | up to 48 weeks | 
| Number of participants with abnormalities in vital signs, electrocardiogram (ECG), and clinically significant laboratory findings |  | up to 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK: maximum plasma concentration (ng/mL) |  | up to 24 weeks | 
| PK: time to reach maximum plasma concentration (h) |  | up to 24 weeks | 
| PK: area under the plasma concentration versus time curve (ng*h/mL) |  | up to 24 weeks | 
| PK: percent of area extrapolated from AUC last to infinity (%) |  | up to 24 weeks | 
| PK: apparent terminal elimination half-life (h) |  | up to 24 weeks | 
| PK: apparent plasma clearance (L/h) |  | up to 24 weeks | 
| PK: apparent volume of distribution (L) |  | up to 24 weeks | 
| Maximum reduction of serum HBsAg from baseline |  | up to 16 weeks | 
| Number of subjects with serum HBsAg loss |  | up to 48 weeks | 
| Number of subjects with sustained serum HBsAg loss for >/= 6 months |  | up to 48 weeks | 
| Number of subjects with anti-HBs seroconversion at any timepoint |  | up to 48 weeks | 
| For HBeAg-positive subjects: Number of subjects with HBeAg loss and/or anti-HBe seroconversion at any timepoint |  | up to 48 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatitis B Virus, Chronic Hepatitis B, HBV, Hepatitis