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.
Participants may be enrolled in Cohorts 1, 2, 3, 4, 5, 6, 7, 8, and 9 in a non-randomized way.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
144
Inland Empire Clinical Trials
Rialto, California, United States
RECRUITINGOrange County Research Center
Tustin, California, United States
RECRUITINGCenExel Research Centers of America
Hollywood, Florida, United States
Maximum observed Plasma concentration (Cmax) of VIR-2218 and metabolite AS(N-1)3'VIR2218
Time frame: 5 days
Area Under The Plasma Concentration-time Curve from Time Zero to Time of Last Quantifiable Concentration (AUClast) of VIR-2218 and metabolite AS(N-1)3'VIR2218
Time frame: 5 days
Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUCinf) of VIR-2218 metabolite AS(N-1)3'VIR2218
Time frame: 5 days
Maximum observed Plasma concentration (Cmax) of VIR-3434
Time frame: 18 weeks
Area Under The Plasma Concentration-time Curve from Time Zero to Time of Last Quantifiable Concentration (AUClast) of VIR-3434
Time frame: 18 weeks
Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUCinf) of VIR-3434
Time frame: 18 weeks
Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
Time frame: Up to 18 Weeks
Incidence of ADA and titers of ADA to VIR-3434 at each study visit for cohorts receiving VIR-3434 therapy
Time frame: 18 Weeks
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Floridian Clinical Research
Miami Lakes, Florida, United States
RECRUITINGTexas Liver Institute
San Antonio, Texas, United States
TERMINATED