NCT07035769 A First-in-Human Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Single and Multiple Oral Doses of Debio 1453P in Healthy Adults
| NCT ID | NCT07035769 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Debiopharm International SA |
| Condition | Healthy Participants |
| Study Type | INTERVENTIONAL |
| Enrollment | 112 participants |
| Start Date | 2025-06-18 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 112 participants in total. It began in 2025-06-18 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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/or physical examination evidence of any clinically significant disease or disorder, such as cardiovascular, pulmonary, renal, hepatic, neurological, gastrointestinal, endocrine, immunological, psychiatric or mental disease or disorder, or mental or legal incapacitation, which, in the opinion of the Investigator, may either put the participant at risk for taking part in the trial, influence the results of the trial, influence the participant's ability to take part in the trial. 2. Any medication (including vaccines, over the counter (OTC) and/or prescription medication, dietary supplements, nutraceuticals, vitamins and/or herbal supplements, and hormonal replacement therapy for postmenopausal participants) for 2 weeks or 5 half-lives of the drug, whichever is longer, prior to first administration of trial drug (except occasional paracetamol (maximum dose of 2 g/day and maximum of 10 g/2 weeks). 3. History of chronic drug or alcohol abuse (defined as an average intake of more than 21 units of alcohol per week for males and 14 for females. 1 unit of alcohol equals approximately 250 mL of beer, 100 mL of wine, or 35 mL of spirits) in the last 2 years.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07035769 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 55 Years, studying Healthy Participants. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07035769 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07035769 currently recruiting?
Yes, NCT07035769 is actively recruiting participants. Contact the research team at clinicaltrials@debiopharm.com for enrollment information.
Where is the NCT07035769 trial being conducted?
This trial is being conducted at Edegem, Belgium.
Who is sponsoring the NCT07035769 clinical trial?
NCT07035769 is sponsored by Debiopharm International SA. The trial plans to enroll 112 participants.