Clinical trial NCT03672188: Study of VIR-2218 in Healthy Subjects and Patients With Chronic Hepatitis B
Official title: A Phase 1/2, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of VIR-2218
Conditions: Chronic Hepatitis B
Summary: 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.
Interventions:
description: VIR-2218 given by subcutaneous injection
name: VIR-2218
type: Drug
description: Sterile normal saline (0.9% NaCl) given by subcutaneous injection
name: Placebo
type: Drug
Study arms:
design_group_description: Healthy subjects received a single dose of VIR-2218 of 50 mg administered SC
design_group_title: Part A: SAD VIR-2218 50 mg
design_group_type: Experimental
design_group_description: Healthy subjects received a single dose of VIR-2218 of 100 mg administered SC
design_group_title: Part A: SAD VIR-2218 100 mg
design_group_type: Experimental
design_group_description: Healthy subjects received a single dose of VIR-2218 of 200 mg administered SC
design_group_title: Part A: SAD VIR-2218 200 mg
design_group_type: Experimental
design_group_description: Healthy subjects received a single dose of VIR-2218 of 400 mg administered SC
design_group_title: Part A: SAD VIR-2218 400 mg
design_group_type: Experimental
design_group_description: Healthy subjects received a single dose of VIR-2218 of 600 mg administered SC
design_group_title: Part A: SAD VIR-2218 600 mg
design_group_type: Experimental
design_group_description: Healthy subjects received a single dose of VIR-2218 of 900 mg administered SC
design_group_title: Part A: SAD VIR-2218 900 mg
design_group_type: Experimental
design_group_description: Healthy subjects received a single dose of placebo administered SC
design_group_title: Part A: SAD Placebo
design_group_type: Placebo Comparator
design_group_description: Chronic HBV, HBeAg negative, subjects received 2 SC doses of 20 mg VIR-2218 administered 4 weeks apart.
design_group_title: Part B: MAD VIR-2218 20 mg
design_group_type: Experimental
design_group_description: Chronic HBV, HBeAg negative, subjects received 2 SC doses of 50 mg VIR-2218 administered 4 weeks apart.
design_group_title: Part B: MAD VIR-2218 50 mg
design_group_type: Experimental
design_group_description: Chronic HBV, HBeAg negative, subjects received 2 SC doses of 100 mg VIR-2218 administered 4 weeks apart.
design_group_title: Part B: MAD VIR-2218 100 mg
design_group_type: Experimental
design_group_description: Chronic HBV, HBeAg negative, subjects received 2 SC doses of 200 mg VIR-2218 administered 4 weeks apart.
design_group_title: Part B: MAD VIR-2218 200 mg
design_group_type: Experimental
design_group_description: Chronic HBV, HBeAg positive, subjects received 2 SC doses of 50 mg VIR-2218 administered 4 weeks apart.
design_group_title: Part C: MAD VIR-2218 50 mg
design_group_type: Experimental
design_group_description: Chronic HBV, HBeAg positive, subjects received 2 SC doses of 200 mg VIR-2218 administered 4 weeks apart.
design_group_title: Part C: MAD VIR-2218 200 mg
design_group_type: Experimental
design_group_description: Chronic HBV, HBeAg negative, subjects received 2 SC doses of placebo administered 4 weeks apart.
design_group_title: Part B: MAD Placebo
design_group_type: Placebo Comparator
design_group_description: Chronic HBV, HBeAg positive, subjects received 2 SC doses of placebo administered 4 weeks apart.
design_group_title: Part C: MAD Placebo
design_group_type: Placebo Comparator
Sponsor: Vir Biotechnology, Inc.
Collaborators: Alnylam Pharmaceuticals, Inc.
Drug name mappings:
name: 艾博西兰
lang: CN
name: Elebsiran
lang: EN