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

NCT07035769 | Recruiting Phase 1 DMC

• 8 other identifiers: Debio 1453-1012024-519328-26U1111-1315-203575A50122C00028224842/Z/21/ZNNF23SA0088536Agreement Dated 1/30/2023Agreement Dated 2/28/2023
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs)

  Up to 15 months

Secondary Outcomes (2)

• Plasma Concentration of Debio 1453P

  Pre-dose and at multiple timepoints post-dose up to Day 12

• Urine Concentration of Debio 1453P

  Pre-dose and at multiple timepoints post-dose up to Day 12

Study Arms (2)

Part 1: Single ascending dose (SAD)

EXPERIMENTAL

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

Drug: Debio 1453P; Drug: Placebo

Part 2: Multiple ascending dose (MAD)

EXPERIMENTAL

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

Interventions

Debio 1453P DRUG

Powder for oral solution

Part 1: Single ascending dose (SAD); Part 2: Multiple ascending dose (MAD)

Placebo DRUG

Oral solution

Part 1: Single ascending dose (SAD); Part 2: Multiple ascending dose (MAD)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Signed and dated written informed consent obtained before undertaking any trial-specific procedures.
• Be within the age range of 18 to 55 years, inclusive, at the time of screening.
• Have a body mass index (BMI) ≥18.5 and ≤30.0 kg/m\^2.

You may not qualify if:

• 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.
• 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).
• 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.

Sponsors & Collaborators

• Debiopharm International SA: lead
• Wellcome Trust: collaborator
• Biomedical Advanced Research and Development Authority: collaborator
• Germany's Federal Ministry of Research, Technology and Space (BMFTR): collaborator
• Global Antimicrobial Resistance Innovation Fund-(GAMRIF): collaborator
• Novo Nordisk Foundation (NNF): collaborator

Study Sites (1)

SGS Belgium NV - Clinical Pharmacology Unit

Edegem, 2650, Belgium

RECRUITING

Central Study Contacts

Debiopharm International S.A

CONTACT

+41213210111; clinicaltrials@debiopharm.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2025
• First Posted: June 25, 2025
• Study Start: June 18, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)