NCT07035769

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

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: Phase 1
• Study type: Interventional
• Enrollment: 88 (estimated)
• Sponsor: Debiopharm International SA · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	Debio 1453P	Powder for oral solution
DRUG	Placebo	Oral solution

Timeline

• Start date: 2025-06-18
• Primary completion: 2026-04-01
• Completion: 2026-11-01
• First posted: 2025-06-25
• Last updated: 2026-03-30

Locations

1 site across 1 country: Belgium