MedTrace Logo

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

NCT07035769 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2026-04-28

No results posted yet for this study

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

Interventions

DRUG

Debio 1453P

Powder for oral solution

DRUG

Placebo

Oral solution

Sponsors & Collaborators

  • Biomedical Advanced Research and Development Authority

    collaborator FED

  • Wellcome Trust

    collaborator OTHER

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

    collaborator UNKNOWN

  • Global Antimicrobial Resistance Innovation Fund-(GAMRIF)

    collaborator UNKNOWN

  • Novo Nordisk Foundation (NNF)

    collaborator UNKNOWN

  • Debiopharm International SA

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-06-18
Primary Completion
2026-10-31
Completion
2026-11-30

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07035769 on ClinicalTrials.gov