NCT04883333

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

A Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of LEO 153339 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: LEO Pharma · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	LEO 153339	LEO 153339
DRUG	Placebo	Placebo

Timeline

• Start date: 2021-05-17
• Primary completion: 2022-07-18
• Completion: 2022-07-18
• First posted: 2021-05-12
• Last updated: 2025-02-24

Locations

1 site across 1 country: Netherlands