First human testing of oral Debio 1453P in healthy adults

A Phase 1, First-in-human, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Oral Doses of Debio 1453P in Healthy Adults

This trial will test whether single and repeated oral doses of Debio 1453P are safe, well tolerated, and how the body processes them in healthy adults aged 18–55.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 88 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: Debiopharm International SA (Industry-sponsored)
• Locations: 1 site (Edegem)
• Trial ID: NCT07035769 on ClinicalTrials.gov

What this trial studies

This first-in-human, phase 1 interventional study gives single and multiple oral doses of Debio 1453P or placebo to healthy adult volunteers across multiple dose levels. Participants are monitored closely for safety and tolerability with physical exams, laboratory testing, vital signs, and ECGs, and blood samples are collected to characterize pharmacokinetics. Dose escalation between cohorts is used to identify tolerable dose ranges and pharmacokinetic profiles. The safety and PK data will guide dose selection for later studies in patients.

Who should consider this trial

Good fit: Healthy adults aged 18–55 with a BMI between 18.5 and 30 kg/m2 who have no significant medical conditions and can give informed consent.

Not a fit: People with active medical problems, recent medication or supplement use, or outside the specified age/BMI ranges are unlikely to be eligible or to benefit from participating.

Why it matters

Potential benefit: If successful, the study could show Debio 1453P is safe enough for further testing and help determine appropriate dosing for future patient trials.

How similar studies have performed: First-in-human safety and PK studies of similar oral small-molecule candidates have often successfully defined safe dose ranges, but Debio 1453P itself is novel and untested in humans.

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.

Where this trial is running

Edegem

• SGS Belgium NV - Clinical Pharmacology Unit — Edegem, Belgium (Recruiting)

Study contacts

• Study coordinator: Debiopharm International S.A

Conditions Healthy Participants