drugset / Trial / NCT06617546
SAD and MAD Study of FTX-101 in Healthy Male Subjects
RandomizedSequentialQuadruple-blindBasic science
Summary
This is a Phase 1, first-in-human (FIH), single-center, randomized, double-blind, placebo-controlled study in healthy male subjects. The study will include the following 2 parts: * Part A: Single Ascending Dose (SAD) in healthy male subjects * Part B: Multiple Ascending Dose (MAD) in healthy male subjects
Timeline
- Start
- 2024-10-14
- Primary completion
- 2025-04-17
- Completion
- 2025-04-17
Outcome
Outcome not reported
Stopped: “Study's goals have been achieved based on a preliminary analysis of available pharmacokinetic and safety data, which demonstrate that sufficient information has been obtained.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | FTX-101 | Peptide | — | Subcutaneous |
Indications
No indication recorded.