Clinical Trial

A First-in-Human Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Single and Multiple Oral Doses of Debio 1453P in Healthy Adults

Recruiting Phase 1
View on ClinicalTrials.gov →
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.
Protocol Amendment History 2 changes
notable Primary completion pushed: 2026-04 -> 2026-10 2026-04-29
minor Completion pushed: 2026-05 -> 2026-11 2026-03-31
Trial Details
NCT Number NCT07035769
Lead Sponsor Debiopharm International SA
Collaborators: Biomedical Advanced Research and Development Authority, Wellcome Trust, Germany's Federal Ministry of Research, Technology and Space (BMFTR), Global Antimicrobial Resistance Innovation Fund-(GAMRIF), Novo Nordisk Foundation
Conditions Healthy Participants
Enrollment 88 participants
Start Date 2025-06-18
Primary Completion 2026-10 (estimated)
Study Completion 2026-11 (estimated)
Updated on ClinicalTrials.gov 2026-07-24