NCT05484206

Effect of Hepatic Impairment on the Pharmacokinetics and Safety of VIR-2218 and VIR-3434

A Phase 1 Open-Label, Single-Dose, Parallel-Group Study of the Pharmacokinetics and Safety of VIR-2218 and VIR-3434 Monotherapy and Combination Therapy in Adult Participants With Hepatic Impairment

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 144 (estimated)
• Sponsor: Vir Biotechnology, Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

In this study, a single dose of VIR-2218 up to 200 mg SC or VIR-3434 at 300 mg SC monotherapy or a combination of VIR-2218 and VIR-3434 will be administered to assess the pharmacokinetic (PK) exposure, safety, and tolerability of VIR-2218 and VIR-3434 in participants with cirrhosis and Hepatic Impairment, defined using the Child-Pugh-Turcotte (CPT) categorization.

Detailed description

Participants may be enrolled in Cohorts 1, 2, 3, 4, 5, 6, 7, 8, and 9 in a non-randomized way.

Conditions

• Hepatic Impairment
• Cirrhosis

Interventions

Type	Name	Description
DRUG	VIR-2218	VIR-2218 given by subcutaneous injection.
DRUG	VIR-3434	VIR-3434 given by subcutaneous injection.

Timeline

• Start date: 2022-09-21
• Primary completion: 2026-09-25
• Completion: 2027-04-30
• First posted: 2022-08-02
• Last updated: 2025-06-13

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study