Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
WITHDRAWN
NCT03995550
PHASE1

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics After Single and Multiple Doses of LEO 142397 in Healthy People, Including Japanese

Sponsor: LEO Pharma

View on ClinicalTrials.gov

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

DRUG

LEO 142397

A compound in development by LEO Pharma A/S

DRUG

Placebo

Placebo

Locations (1)

Covance Clinical Research Unit Ltd.

Leeds, United Kingdom