drugset / Trial / NCT04883333

A Single and Multiple Ascending-dose Trial of LEO 153339 in Healthy Adults

NCT04883333 ↗

Phase 1 Completed 108 enrolled LEO Pharma ICON plc · collab
RandomizedParallel-groupDouble-blindTreatment

Summary

This is a first-in-human study in adult healthy participants consisting of two parts. In Part 1, participants will receive one dose of study drug (LEO 153339) or placebo; in Part 2, participants will receive multiple doses of study drug or placebo. The participants will stay in the clinic for 6 days (Part 1) or for 12 days (Part 2) to have the study doctor assess their safety and to investigate how quickly and to what extent LEO 153339 (and the breakdown product) is absorbed, transported, and eliminated from the body. The purpose is to assess the safety and tolerability of LEO 153339 when compared to a placebo with no active ingredient.

Timeline

Start
2021-05-17
Primary completion
2022-07-18
Completion
2022-07-18

Drugs

EvaluationDrugModalityDoseRoute
Subject LEO 153339 Unknown — —

Indications

No indication recorded.