drugset / Trial / NCT07035769
A First-in-Human Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Single and Multiple Oral Doses of Debio 1453P in Healthy Adults
Phase 1
Recruiting
88 enrolled
Debiopharm International SA
Biomedical Advanced Research and Development Authority · collabGermany's Federal Ministry of Research, Technology and Space (BMFTR) · collabGlobal Antimicrobial Resistance Innovation Fund-(GAMRIF) · collabNovo Nordisk Foundation (NNF) · collabWellcome Trust · collab
RandomizedSequentialQuadruple-blindTreatment
Summary
The main purpose of this study is to evaluate the safety, tolerability and pharmacokinetics (PK) of Debio 1453P compared to placebo across different dose levels in healthy adults after single and repeated oral dosing.
Timeline
- Start
- 2025-06-18
- Primary completion
- 2026-10
- Completion
- 2026-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Debio 1453P | Unknown | — | Oral |
Indications
No indication recorded.