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

PHASE1RecruitingINTERVENTIONAL
Enrollment

88

Participants

Timeline

Start Date

June 18, 2025

Primary Completion Date

April 30, 2026

Study Completion Date

May 31, 2026

Conditions
Healthy Participants
Interventions
DRUG

Debio 1453P

Powder for oral solution

DRUG

Placebo

Oral solution

Trial Locations (1)

2650

RECRUITING

SGS Belgium NV - Clinical Pharmacology Unit, Edegem

Sponsors
All Listed Sponsors
collaborator

Biomedical Advanced Research and Development Authority

FED

collaborator

Wellcome Trust

OTHER

collaborator

Germany's Federal Ministry of Research, Technology and Space (BMFTR)

UNKNOWN

collaborator

Global Antimicrobial Resistance Innovation Fund-(GAMRIF)

UNKNOWN

collaborator

Novo Nordisk Foundation (NNF)

UNKNOWN

lead

Debiopharm International SA

INDUSTRY