Actively Recruiting
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
88
Participants Needed
1
Research Sites
4 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
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
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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants receive a single oral dose of Debio 1453P or placebo on Day 1 to evaluate safety, tolerability, and pharmacokinetics.
1 visit (in-person)
Duration - 5 days
Participants receive multiple oral doses of Debio 1453P or placebo daily from Day 1 to Day 5 based on data from the single dose part.
Daily visits for up to 5 days
Duration - Up to 15 months
Participants are monitored for safety and adverse events after dosing up to 15 months.
Periodic visits for safety assessments
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
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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