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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
Sponsor: Debiopharm International SA
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
88
Start Date
2025-06-18
Completion Date
2026-11
Last Updated
2026-03-30
Healthy Volunteers
Yes
Conditions
Interventions
Debio 1453P
Powder for oral solution
Placebo
Oral solution
Locations (1)
SGS Belgium NV - Clinical Pharmacology Unit
Edegem, Belgium