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

Phase 1

Recruiting

• Conditions: Healthy Participants
• Interventions: Drug: Debio 1453P; Drug: Placebo

• Registration Number: NCT07035769
• Lead Sponsor: Debiopharm International SA

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-06-16
• Study First Submitted QC: 2025-06-16
• Study Start: 2025-06-18
• Study First Posted: 2025-06-25
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-29
• Last Update Posted: 2025-10-02
• Primary Completion: 2026-04
• Study Completion: 2026-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Part 1: Single ascending dose (SAD)	Debio 1453P	Participants will receive a single oral dose of Debio 1453P or placebo in a sequential manner on Day 1.
Part 1: Single ascending dose (SAD)	Placebo	Participants will receive a single oral dose of Debio 1453P or placebo in a sequential manner on Day 1.
Part 2: Multiple ascending dose (MAD)	Debio 1453P	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.
Part 2: Multiple ascending dose (MAD)	Placebo	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs)	Up to 15 months

Secondary Outcome Measures

Name	Time	Method
Urine Concentration of Debio 1453P	Pre-dose and at multiple timepoints post-dose up to Day 12	The PK of Debio 1453P will be evaluated in urine.
Plasma Concentration of Debio 1453P	Pre-dose and at multiple timepoints post-dose up to Day 12	The PK of Debio 1453P will be evaluated in plasma.

Trial Locations

Locations (1)

SGS Belgium NV - Clinical Pharmacology Unit; 🇧🇪 Edegem, Belgium