First human testing of oral Debio 1453P in healthy adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• SGS Belgium NV - Clinical Pharmacology Unit
  Edegem, Belgium Recruiting

Study contacts

• Study coordinator: Debiopharm International S.A
• Email: clinicaltrials@debiopharm.com
• Phone: +41213210111

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.