Actively Recruiting
A First-in-Human Study 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 2026-04-28
88
Participants Needed
1
Research Sites
71 weeks
Total Duration
On this page
Sponsors
D
Debiopharm International SA
Lead Sponsor
B
Biomedical Advanced Research and Development Authority
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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
Eligibility Criteria
You may qualify if you...
- Signed and dated written informed consent before any trial-specific procedures
- Age between 18 and 55 years at screening
- Body mass index (BMI) between 18.5 and 30.0 kg/m²
You will not qualify if you...
- Any clinically significant disease or disorder that may increase risk or affect trial results
- Use of any medication, including vaccines, supplements, or hormonal therapy, within 2 weeks prior to first trial drug administration (except occasional paracetamol up to 2 g/day)
- History of chronic drug or alcohol abuse in the last 2 years
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
SGS Belgium NV - Clinical Pharmacology Unit
Edegem, Belgium, 2650
Actively Recruiting
Research Team
D
Debiopharm International S.A
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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