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Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics After Single and Multiple Doses of LEO 142397 in Healthy People, Including Japanese
Sponsor: LEO Pharma
Summary
This is the first clinical trial with LEO 142397. The purpose of the trial is to assess the safety and tolerability of LEO 142397, along with the pharmacokinetics (what the body does to the drug) and the pharmacodynamics (what the drug does to the body) in healthy people. The trial consists of 2 parts: * In Part 1, participants will receive a single dose of LEO 142397. There will be up to 8 different dose groups. * In Part 2, participants will receive a daily dose of LEO 142397 for 14 days. There will be up to 6 different dose groups. Each participant will be enrolled into 1 dose group in either Part 1 or Part 2.
Official title: A Randomised, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LEO 142397 in Healthy Subjects
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
0
Start Date
2019-07-03
Completion Date
2020-07-16
Last Updated
2026-05-01
Healthy Volunteers
Yes
Conditions
Interventions
LEO 142397
A compound in development by LEO Pharma A/S
Placebo
Placebo
Locations (1)
Covance Clinical Research Unit Ltd.
Leeds, United Kingdom