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
Vir Biotechnology, Inc.
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.
Description
Participants may be enrolled in Cohorts 1, 2, 3, 4, 5, 6, 7, 8, and 9 in a non-randomized way.
Eligibility
- Age range
- 18–70 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * Must be ≥18 to ≤70 years of age at screening * Must have a calculated BMI from 18.5 ≤ BMI ≤ 40 kg/m2 * All participants must have an eGFR ≥ 60 mL/min as calculated by the Modification of Diet in Renal Disease (MDRD) equation Inclusion criteria: Healthy matched participants * Must in the opinion of the Investigator, be in good health based upon medical history, vital signs, physical examination, and screening laboratory evaluations Inclusion criteria: Hepatic impaired participants * Apart from hepatic insufficiency, participants must, in the opinion of the Investigato…
Interventions
- DrugVIR-2218
VIR-2218 given by subcutaneous injection.
- DrugVIR-3434
VIR-3434 given by subcutaneous injection.
Locations (5)
- Inland Empire Clinical TrialsRialto, California
- Orange County Research CenterTustin, California
- CenExel Research Centers of AmericaHollywood, Florida
- Floridian Clinical ResearchMiami Lakes, Florida
- Texas Liver InstituteSan Antonio, Texas