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COMPLETED
NCT04883333
PHASE1

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

Sponsor: LEO Pharma

View on ClinicalTrials.gov

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

DRUG

LEO 153339

LEO 153339

DRUG

Placebo

Placebo

Locations (1)

LEO Pharma Investigational Site

Groningen, NZ, Netherlands