Clinical Research Directory
Browse clinical research sites, groups, and studies.
A Single and Multiple Ascending-dose Trial of LEO 153339 in Healthy Adults
Sponsor: LEO Pharma
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.
Official title: A Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of LEO 153339 in Healthy Subjects
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
108
Start Date
2021-05-17
Completion Date
2022-07-18
Last Updated
2026-04-28
Healthy Volunteers
Yes
Conditions
Interventions
LEO 153339
LEO 153339
Placebo
Placebo
Locations (1)
LEO Pharma Investigational Site
Groningen, NZ, Netherlands