drugset / Trial / NCT06274853
GS-441524 for COVID-19 SAD, FE, and MAD Study in Healthy Subjects
Phase 1
Withdrawn
National Center for Advancing Translational Sciences (NCATS)
ICON plc · collabLeidos Biomedical Research, Inc. · collab
RandomizedSequentialQuadruple-blindTreatment
Summary
The goal of this clinical trial is to evaluate the safety, tolerability, and pharmacokinetics of GS-441524 in healthy subjects. The main questions to answer are: 1) What dosage of GS-441524 is required for adequate therapeutic plasma levels? 2) Does fed or fasted state produce variability in plasma levels? 3) How is GS-441524 eliminated from the body. Participants will receive varying levels of GS-441524 or placebo to evaluate AEs and plasma levels.
Timeline
- Start
- 2024-06-15
- Primary completion
- 2024-12
- Completion
- 2024-12
Outcome
Outcome not reported
Stopped: “Operational Reasons”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | GS-441524 | Small molecule | 100 mg | Oral |
| Subject | GS-441524 | Small molecule | 300 mg | Oral |
| Subject | GS-441524 | Small molecule | 600 mg | Oral |
| Subject | GS-441524 | Small molecule | 1000 mg | Oral |