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.
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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

Debiopharm International S.A

+41213210111

clinicaltrials@debiopharm.com

CONTACT