RecruitingPhase 1NCT07035769

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

Sponsor

Debiopharm International SA

Enrollment

88 participants

Start Date

Jun 18, 2025

Study Type

INTERVENTIONAL

Conditions

Healthy Participants

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.

Eligibility

Min Age: 18 YearsMax Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Debio 1453P and a drug called Placebo for people with healthy participants. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 55 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDebio 1453P

Powder for oral solution

DRUGPlacebo

Oral solution

Locations(1)

SGS Belgium NV - Clinical Pharmacology Unit

Edegem, Belgium

View Full Details on ClinicalTrials.gov

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NCT07035769

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