What is Debio 1453P studying for healthy adults?

Debio 1453P is being studied to understand its safety, how well it is tolerated, and how the body processes it after single and multiple oral doses in healthy adults. This helps researchers learn about the drug's effects before testing it in patients with medical conditions. The study is sponsored by Debiopharm International SA.

Who may be eligible for this healthy adult clinical trial?

Adults aged 18 to 55 years with a body mass index between 18.5 and 30.0 kg/m² may be eligible. Participants should be healthy without significant medical conditions and not have used most medications recently. The trial accepts all genders. Please review eligibility criteria for more details.

Is there any cost to participate in this healthy adult clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered. Participants can plan accordingly for their travel and related expenses.

Actively Recruiting

Phase 1

Age: 18Years - 55Years

All Genders

Healthy Volunteers

ID07035769

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

Led by Debiopharm International SA · Updated on 2026-05-28

Participants Needed

Research Sites

4 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the safety, tolerability, and how the body processes Debio 1453P compared to a placebo in healthy adults. This Phase 1 trial is the first time Debio 1453P is given to humans, aiming to study different dose levels after single and multiple oral doses. The study focuses on monitoring any adverse events and measuring drug levels in blood and urine to better understand its effects. Participants will receive either Debio 1453P or a placebo orally. Initially, they will get a single dose on Day 1, followed by multiple doses from Day 1 to Day 5. The starting dose for the multiple-dose part will be based on data from the single-dose part. This approach helps researchers assess how the drug behaves with repeated dosing. During the study, participants will be closely monitored for any treatment-related side effects over a period of up to 15 months. Blood and urine samples will be collected before dosing and at multiple times afterward, up to Day 12, to measure the concentration of Debio 1453P. The trial involves healthy adults aged 18 to 55 and includes careful assessment to ensure safety and gather detailed pharmacokinetic data throughout the study.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 55Years

All Genders

Healthy Volunteers

Eligibility Criteria

You may qualify if you...

Signed and dated informed consent before any trial procedures
Age between 18 and 55 years inclusive at screening
Body mass index (BMI) between 18.5 and 30.0 kg/m²

You will not qualify if you...

History or evidence of any significant disease or disorder affecting major organs or mental health
Use of medications, supplements, or hormone therapy within 2 weeks or 5 half-lives before trial drug administration, except occasional paracetamol within limits
History of chronic drug or alcohol abuse in the last 2 years, defined by specified weekly alcohol intake limits

Research Team

Debiopharm International S.A

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