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

NCT05484206 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2025-06-13

No results posted yet for this study

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.

Conditions

  • Hepatic Impairment
  • Cirrhosis

Interventions

DRUG

VIR-2218

VIR-2218 given by subcutaneous injection.

DRUG

VIR-3434

VIR-3434 given by subcutaneous injection.

Sponsors & Collaborators

  • Vir Biotechnology, Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-09-21
Primary Completion
2026-09-25
Completion
2027-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05484206 on ClinicalTrials.gov