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

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 6 words
    • Collaborators: details revised at 1 of 5 entries
  2. 4 versions Re-verified since May 26, 2026, no change to tracked fieldsv11-v14
  3. Primary completion pushed from Apr 2026 to Oct 2026v10
  4. Study completion pushed from May 2026 to Nov 2026v9
  5. 6 versions Re-verified since Sep 29, 2025, no change to tracked fieldsv3-v8
  6. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Collaborators revised (5)
    v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
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
(from sponsor)		 Healthy Participants
Enrollment 88 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov