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The rationale of this study is to evaluate the impact of renal function on the PK, safety, and tolerability of VIR-2218 in participants with normal renal function and participants with varying degrees of renal dysfunction who are otherwise medically stable
Participants may be enrolled in Cohorts 1 and 2 in a non-randomized way.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: Up to 8 moderate Renal Impairment (RI) participants and 8 matched healthy participants | Experimental |
| |
| Cohort 2: Up to 8 severe Renal Impairment (RI) participants and 6 matched healthy participants | Experimental |
|
| 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 its metabolite AS(N-1)3'VIR-2218 | 5 days | |
| Area Under The Plasma Concentration-time Curve from Time Zero to Time of Last Quantifiable Concentration (AUClast) of VIR-2218 and its metabolite AS(N-1)3'VIR-2218 | 5 days | |
| Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUCinf) of VIR-2218 and its metabolite AS(N-1)3'VIR-2218 | 5 days | |
| Fraction excreted in urine in percentage for VIR-2218 and its metabolite AS(N-1)3'VIR-2218 | 5 days | |
| Amount excreted in urine for VIR-2218 and its metabolite AS(N-1)3'VIR-2218 | 5 days | |
| Renal clearance for VIR-2218 and its metabolite AS(N-1)3'VIR-2218 | 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) | Up to 12 weeks |
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Inclusion Criteria for All Participants:
Inclusion Criteria: Additional Criteria Specific to Healthy Participants:
Inclusion Criteria: Additional Criteria Specific to Participants with Renal Impairment
Exclusion Criteria: Criteria for All Participants
Exclusion Criteria: Additional Criteria Specific to Healthy Participants
Exclusion Criteria: Additional Criteria Specific to Participants with Renal Impairment
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inland Empire Clinical Trials | Rialto | California | 92377 | United States | ||
| Floridian Clinical Research |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 22, 2026 | |
| Reset | May 13, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 22, 2026 | May 13, 2026 | |||
| Jun 26, 2026 |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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|
| Miami Lakes |
| Florida |
| 33016 |
| United States |
| Orlando Clinical Research Center | Orlando | Florida | 32809 | United States |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |