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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: CPT-B (moderate HI) participants and matched healthy participants will be evaluated first | Experimental | All participants in Cohort 1 will be receiving VIR-2218 monotherapy. |
|
| Cohort 2: CPT-C (severe HI) participants and matched healthy participants | Experimental | This arm is optional based on Cohort 1. All participants in Cohort 2 will be receiving VIR-2218 monotherapy. |
|
| Cohort 3: CPT-A (mild HI) participants and matched healthy participants | Experimental | This cohort is optional. All participants in Cohort 3 will be receiving VIR-2218 monotherapy. |
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| Cohort 4: CPT-A (mild HI) participants and matched healthy participants | Experimental | All participants in Cohort 4 will be receiving VIR-3434 monotherapy. |
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| Cohort 5: CPT-B (moderate HI) participants and matched healthy participants | Experimental | All participants in Cohort 5 will be receiving VIR-3434 monotherapy. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VIR-2218 | Drug | VIR-2218 given by subcutaneous injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed Plasma concentration (Cmax) of VIR-2218 and metabolite AS(N-1)3'VIR2218 | 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 | 5 days | |
| Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUCinf) of VIR-2218 metabolite AS(N-1)3'VIR2218 | 5 days | |
| Maximum observed Plasma concentration (Cmax) of VIR-3434 | 18 weeks | |
| Area Under The Plasma Concentration-time Curve from Time Zero to Time of Last Quantifiable Concentration (AUClast) of VIR-3434 | 18 weeks | |
| Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUCinf) of VIR-3434 | 18 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) | Up to 18 Weeks | |
| Incidence of ADA and titers of ADA to VIR-3434 at each study visit for cohorts receiving VIR-3434 therapy | 18 Weeks |
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Inclusion Criteria:
Inclusion criteria: Healthy matched participants
Inclusion criteria: Hepatic impaired participants
Exclusion Criteria:
Exclusion criteria: Healthy matched participants
Exclusion criteria: Participants with Hepatic impairment
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inland Empire Clinical Trials | Recruiting | Rialto | California | 92377 | United States |
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| ID | Term |
|---|---|
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Cohort 6: CPT-C (severe HI) participants and matched healthy participants | Experimental | This arm is optional based on Cohort 5. All participants in Cohort 6 will be receiving VIR-3434 monotherapy. |
|
| Cohort 7: CPT-A (mild HI) and matched healthy participants | Experimental | All participants in Cohort 7 will be receiving VIR-3434 and VIR-2218 combination therapy. |
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| Cohort 8: CPT-B (moderate HI) and matched healthy participants | Experimental | All participants in Cohort 8 will be receiving VIR-3434 and VIR-2218 combination therapy. |
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| Cohort 9: CPT-C (severe HI) and matched healthy participants | Experimental | This arm is optional based on Cohort 8. All participants in Cohort 9 will be receiving VIR-3434 and VIR-2218 combination therapy. |
|
| VIR-3434 | Drug | VIR-3434 given by subcutaneous injection. |
|
| Orange County Research Center | Recruiting | Tustin | California | 92790 | United States |
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| CenExel Research Centers of America | Withdrawn | Hollywood | Florida | 33024 | United States |
| Floridian Clinical Research | Recruiting | Miami Lakes | Florida | 33016 | United States |
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| Texas Liver Institute | Terminated | San Antonio | Texas | 78215 | United States |