A Phase 1 interventional study of Debio 1453P and Placebo in Healthy Participants, sponsored by Debiopharm International SA. Recruiting at 1 site in Belgium. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by Debiopharm International SA (part of Debiopharm) · Phase 1, Interventional, and Treatment
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.
Debiopharm International SA is the lead sponsor of 51 studies on the registry; 6 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive a single oral dose of Debio 1453P or placebo in a sequential manner on Day 1.
Drug: Debio 1453P · Drug: Placebo
Participants will receive multiple oral doses of Debio 1453P or placebo from Day 1 to Day 5. Debio 1453P initial dose in this part will be based on available data from SAD part.
Drug: Debio 1453P · Drug: Placebo
Powder for oral solution
Oral solution
Number of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to 15 months
Plasma Concentration of Debio 1453P
The PK of Debio 1453P will be evaluated in plasma.
Time frame: Pre-dose and at multiple timepoints post-dose up to Day 12
Urine Concentration of Debio 1453P
The PK of Debio 1453P will be evaluated in urine.
Time frame: Pre-dose and at multiple timepoints post-dose up to Day 12
Plan to share: No
No publications or documents are linked to this record.
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