LEO 29102 Single and Multiple Dose Study by Dermal Application

LEO Pharma64 enrolled

Overview

The principal aim of this study is to obtain safety, tolerability and pharmacokinetic data when LEO 29102 is administered cutaneously as single and multiple doses to healthy male subjects. The study is divided into one single dose part followed by a multiple dose part.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

TRIPLE

Enrollment

Conditions

Atopic Dermatitis

Interventions

LEO 29102DRUG

First-in-man. Healthy volunteers

Eligibility

Sex: MALEMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Male adults between the age of 18 and 55 years (both inclusive) and with a BMI between 19 and 30 kg/m2 (both inclusive). * Subjects must be healthy as determined by medical history, physical examination, electrocardiogram (ECG), blood pressuer and heart rate, and clinical laboratory evaluation. Exclusion Criteria: * Subjects who show signs of eczema or other skin lesions. * Subjects who have any clinical signs of allergic diseases (excluding non active hay fever).

Locations (1)

LCG Bioscience

Bourn, Cambridgeshire, United Kingdom

Outcomes

Primary Outcomes

To determine the safety and tolerability

Secondary Outcomes

To determine the pharmacokinetics

Data from ClinicalTrials.gov

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