A First-in-Human Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Single and Multiple Oral Doses of Debio 1453P in Healthy Adults

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-18

Study Completion Date

2026-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy Participants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Part 1: Single ascending dose (SAD)

Participants will receive a single oral dose of Debio 1453P or placebo in a sequential manner on Day 1.

Group Type EXPERIMENTAL

Debio 1453P

Intervention Type DRUG

Powder for oral solution

Placebo

Intervention Type DRUG

Oral solution

Part 2: Multiple ascending dose (MAD)

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.

Group Type EXPERIMENTAL

Debio 1453P

Intervention Type DRUG

Powder for oral solution

Placebo

Intervention Type DRUG

Oral solution

Interventions

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Debio 1453P

Powder for oral solution

Intervention Type DRUG

Placebo

Oral solution

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Locations

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SGS Belgium NV - Clinical Pharmacology Unit

Edegem, , Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Debiopharm International S.A

Role: CONTACT

Phone: +41213210111

Email: [email protected]