NCT05844228

A Study to Investigate the Effect of Renal Impairment on the Pharmacokinetics and Safety of VIR-2218

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Vir Biotechnology, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

The rationale of this study is to evaluate the impact of renal function on the PK, safety, and tolerability of VIR-2218 in participants with normal renal function and participants with varying degrees of renal dysfunction who are otherwise medically stable

Detailed description

Participants may be enrolled in Cohorts 1 and 2 in a non-randomized way.

Conditions

• Renal Impairment

Interventions

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

Timeline

• Start date: 2023-06-01
• Primary completion: 2025-03-01
• Completion: 2025-04-21
• First posted: 2023-05-06
• Last updated: 2025-06-13

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study