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A Phase 1, First-in-human, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Oral Doses of Debio 1453P in Healthy Adults

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Trial Profile

A Phase 1, First-in-human, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Oral Doses of Debio 1453P in Healthy Adults

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 04 Oct 2025

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At a glance

  • Drugs Debio 1453 (Primary)
  • Indications Gonorrhoea; Neisseria infections
  • Focus Adverse reactions; First in man
  • Sponsors Debiopharm; Debiopharm Group

Most Recent Events

  • 26 Aug 2025 According to Debiopharm media release, the first healthy volunteer has been dosed in this trial.
  • 08 Aug 2025 Status changed from not yet recruiting to recruiting.
  • 25 Jun 2025 Status changed from planning to not yet recruiting.

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