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

Recruiting Phase 1 Interventional Study
Hepatic Impairment Cirrhosis
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Healthy Volunteers Welcome You do not need to have the condition being studied to take part.
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At a Glance
Age
18 – 70
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
144 (estimated)
Sponsor
Vir Biotechnology, Inc. · Industry
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About This Trial

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.

Trial Locations
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Eligibility Criteria
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 *…
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