A First-in-Human Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Single and Multiple Oral Doses of Debio 1453P in Healthy Adults
Recruiting
Phase 1
Interventional Study
Healthy Participants
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 18 – 55
- Sex
- Any
- Trial phase
- Phase 1
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 88 (estimated)
- Sponsor
- Debiopharm International SA · Industry
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About This Trial
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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria
1. Signed and dated written informed consent obtained before undertaking any trial-specific procedures.
2. Be within the age range of 18 to 55 years, inclusive, at the time of screening.
3. Have a body mass index (BMI) ≥18.5 and ≤30.0 kg/m\^2.
Exclusion criteria
1. History and/…
Contacts