A Phase 1, First in Man, Safety, Tolerability and Pharmacokinetic Study of Single Ascending and Multiple Cutaneous Doses of LEO 29102 2.5 mg/g Cream or LEO 29102 Cream Vehicle in Healthy Male Subjects

LEO Pharma1 site in 1 country64 target enrollmentMarch 2009

ConditionsAtopic Dermatitis

InterventionsLEO 29102

DrugsLEO 29102

Overview

Phase: Phase 1
Intervention: LEO 29102
Conditions: Atopic Dermatitis
Sponsor: LEO Pharma
Enrollment: 64
Locations: 1
Primary Endpoint: To determine the safety and tolerability
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

March 2009

End Date

June 2009

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

LEO Pharma

Responsible Party

Sponsor

Eligibility Criteria

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.