Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GS-0415 · 1 trial · 1 indication
AUCinf is defined as the area under the concentration versus time curve extrapolated to infinite time, calculated as AUClast + (Clast/λz).
Cmax is defined as the maximum observed concentration of drug.
AUCtau is defined as the area under the concentration versus time curve over the dosing interval.
| Arm | Type | Description |
|---|---|---|
| Group A Single Ascending Dose (SAD): GS-0415 | EXPERIMENTAL | Participants will receive single escalating doses of GS-0415 via subcutaneous (SC) or intravenously (IV) on Day 1. |
| Group A SAD: Placebo | EXPERIMENTAL | Participants will receive placebo to match the single escalating doses of GS-0415 via SC or IV on Day 1. |
| Group B SAD: GS-0415 | EXPERIMENTAL | Participants will receive single escalating doses of GS-0415 via SC or IV on Day 1. |
| Group B SAD: Placebo | EXPERIMENTAL | Participants will receive placebo to match the single escalating doses of GS-0415 via SC or IV on Day 1. |
| Group C Multiple Ascending Dose (MAD): GS-0415 | EXPERIMENTAL | Participants will receive escalating doses of GS-0415 via SC or IV at five different timepoints up to Date 57. |
| Group C MAD: Placebo | EXPERIMENTAL | Participants will receive placebo to match escalating doses of GS-0415 via SC or IV at five different timepoints up to Day 57. |
| Name | Type | Description |
|---|---|---|
| GS-0415 | DRUG | Administered SC or IV |
| GS-0415 Placebo | DRUG | Administered SC or IV |
Key Inclusion Criteria: * Age ≥ 18 years and age ≤ 65 years at screening * On stable antiretroviral (ARV) treatment for ≥ 12 consecutive months prior to screening, throughout the duration of study treatment and follow-up * The following ARV agents are not allowed as part of the current ART regimen:...
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GS-0415 is an investigational small molecule being developed for the treatment of HIV-1 infection. It is currently in Phase 1 clinical development, meaning it has not yet been approved by regulatory authorities and is still being studied for safety and efficacy in humans.
GS-0415 is being developed by Gilead Sciences, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol GILD. The company is conducting clinical research to evaluate the drug's potential as a treatment for HIV-1 infection.
GS-0415 is in Phase 1 clinical development. It is an investigational drug, not yet approved by the FDA or other regulatory agencies. The ongoing Phase 1 trial is actively recruiting participants to study the drug's safety, tolerability, and how it works in people with HIV.
GS-0415 is being studied in a Phase 1 clinical trial with the identifier NCT07719491, titled 'Study of GS-0415 and How It Works in People With HIV.' This randomized, controlled trial is recruiting 112 participants in the United States, with an enrollment age minimum of 18 years.
No alternative names for GS-0415 have been reported. It is identified solely by its development code GS-0415 and is being studied as a distinct investigational compound for HIV-1 infection.