Phase 1 Evaluation of Safety and Pharmacokinetics for Single and Multiple Oral Doses of Debio 1453P in Healthy Adults Aged 18 to 55

What this Trial Is About

Researchers are evaluating the safety, tolerability, and pharmacokinetics of Debio 1453P, a new oral drug, compared to placebo in healthy adults aged 18 to 55 years. This Phase 1 study aims to understand how the drug is processed in the body and its effects after single and repeated doses. The trial involves healthy adult volunteers without significant medical conditions. Participants will receive either Debio 1453P or a placebo in two parts first, a single oral dose on Day 1 in a sequential manner, and second, multiple oral doses from Day 1 to Day 5. The initial dose for the repeated dosing phase will be based on data from the single dose part. Both Debio 1453P and placebo are given as oral solutions. During the study, participants will be monitored for any treatment-emergent adverse events up to 15 months. Blood and urine samples will be collected before dosing and at multiple timepoints up to Day 12 to measure the concentration of Debio 1453P. The study includes randomization and quadruple masking to ensure unbiased results. Participants can expect regular assessments and safety monitoring throughout their involvement.

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