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RECRUITING
NCT07035769
PHASE1

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

Sponsor: Debiopharm International SA

View on ClinicalTrials.gov

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.

Official title: A Phase 1, First-in-human, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Oral Doses of Debio 1453P in Healthy Adults

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

88

Start Date

2025-06-18

Completion Date

2026-11

Last Updated

2026-03-30

Healthy Volunteers

Yes

Interventions

DRUG

Debio 1453P

Powder for oral solution

DRUG

Placebo

Oral solution

Locations (1)

SGS Belgium NV - Clinical Pharmacology Unit

Edegem, Belgium