drugset / Trial / NCT05484206
Effect of Hepatic Impairment on the Pharmacokinetics and Safety of VIR-2218 and VIR-3434
Non-randomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2022-09-21
- Primary completion
- 2026-09-25
- Completion
- 2027-04-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tobevibart | Monoclonal antibody | 300 mg | Subcutaneous |
| Subject | VIR-2218 | Small interfering RNA (siRNA) | 200 mg | Subcutaneous |