Study of VIR-2218 in Healthy Subjects and Patients With Chronic Hepatitis B

Vir Biotechnology

Status and phase: Completed; Phase 2; Phase 1

Conditions: Chronic Hepatitis B

Treatments: Drug: Placebo; Drug: VIR-2218

Study type: Interventional

Funder types: Industry

Identifiers

NCT03672188

VIR-2218-1001

Details and patient eligibility

About

This is a phase 1/2 study in which healthy adult subjects and subjects with chronic hepatitis B virus (HBV) infection will receive VIR-2218 or placebo and will be assessed for safety, tolerability, pharmacokinetics, and antiviral activity (only in subjects with chronic HBV).

In the single ascending dose (SAD) part, Part A, healthy adult subjects will receive one dose of VIR-2218 or placebo, administered subcutaneously (SC). In the multiple ascending dose (MAD) parts, Part B & Part C, subjects with chronic HBV infection will receive two doses of VIR-2218 or placebo every 4 weeks administered SC.

Enrollment: 82 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Part A SAD:

Inclusion Criteria:

• Male or female age 18 - 55
• BMI 18 - 32 kg/m^2

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 intolerance to SC injection

Parts B/C MAD:

Inclusion Criteria:

• Male or female age 18 - 65
• BMI 18 - 32 kg/m^2
• Chronic HBV infection 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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82 participants in 15 patient groups, including a placebo group

Part A: SAD VIR-2218 50 mg

Experimental group

Description:

Healthy subjects received a single dose of VIR-2218 of 50 mg administered SC

Treatment:

Drug: VIR-2218

Part A: SAD VIR-2218 100 mg

Experimental group

Description:

Healthy subjects received a single dose of VIR-2218 of 100 mg administered SC

Treatment:

Drug: VIR-2218

Part A: SAD VIR-2218 200 mg

Experimental group

Description:

Healthy subjects received a single dose of VIR-2218 of 200 mg administered SC

Treatment:

Drug: VIR-2218

Part A: SAD VIR-2218 400 mg

Experimental group

Description:

Healthy subjects received a single dose of VIR-2218 of 400 mg administered SC

Treatment:

Drug: VIR-2218

Part A: SAD VIR-2218 600 mg

Experimental group

Description:

Healthy subjects received a single dose of VIR-2218 of 600 mg administered SC

Treatment:

Drug: VIR-2218

Part A: SAD VIR-2218 900 mg

Experimental group

Description:

Healthy subjects received a single dose of VIR-2218 of 900 mg administered SC

Treatment:

Drug: VIR-2218

Part A: SAD Placebo

Placebo Comparator group

Description:

Healthy subjects received a single dose of placebo administered SC

Treatment:

Drug: Placebo

Part B: MAD VIR-2218 20 mg

Experimental group

Description:

Chronic HBV, HBeAg negative, subjects received 2 SC doses of 20 mg VIR-2218 administered 4 weeks apart.

Treatment:

Drug: VIR-2218

Part B: MAD VIR-2218 50 mg

Experimental group

Description:

Chronic HBV, HBeAg negative, subjects received 2 SC doses of 50 mg VIR-2218 administered 4 weeks apart.

Treatment:

Drug: VIR-2218

Part B: MAD VIR-2218 100 mg

Experimental group

Description:

Chronic HBV, HBeAg negative, subjects received 2 SC doses of 100 mg VIR-2218 administered 4 weeks apart.

Treatment:

Drug: VIR-2218

Part B: MAD VIR-2218 200 mg

Experimental group

Description:

Chronic HBV, HBeAg negative, subjects received 2 SC doses of 200 mg VIR-2218 administered 4 weeks apart.

Treatment:

Drug: VIR-2218

Part C: MAD VIR-2218 50 mg

Experimental group

Description:

Chronic HBV, HBeAg positive, subjects received 2 SC doses of 50 mg VIR-2218 administered 4 weeks apart.

Treatment:

Drug: VIR-2218

Part C: MAD VIR-2218 200 mg

Experimental group

Description:

Chronic HBV, HBeAg positive, subjects received 2 SC doses of 200 mg VIR-2218 administered 4 weeks apart.

Treatment:

Drug: VIR-2218

Part B: MAD Placebo

Placebo Comparator group

Description:

Chronic HBV, HBeAg negative, subjects received 2 SC doses of placebo administered 4 weeks apart.

Treatment:

Drug: Placebo

Part C: MAD Placebo

Placebo Comparator group

Description:

Chronic HBV, HBeAg positive, subjects received 2 SC doses of placebo administered 4 weeks apart.

Treatment:

Drug: Placebo