A Phase I, First-in-Human, Vehicle Controlled, Single Ascending Dose Trial Evaluating the Safety, Tolerability and Pharmacokinetics in Male Subjects With AD and in Healthy Male Subjects of Cutaneous Application of LEO 39652 Cream

LEO Pharma2 sites in 1 country23 target enrollmentMay 2013

ConditionsAtopic Dermatitis

InterventionsLEO 39652 cream cream vehicle

DrugsLEO 39652 cream cream vehicle

Overview

Phase: Phase 1
Intervention: LEO 39652 cream
Conditions: Atopic Dermatitis
Sponsor: LEO Pharma
Enrollment: 23
Locations: 2
Primary Endpoint: Number of subjects with adverse events and change from baseline in vital signs (blood pressure, pulse rate) ECG, clinical laboratory and local tolerability assessments
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The principle aim of this study is to obtain safety, tolerability and pharmacokinetic data when LEO 39652 cream is administered cutaneously as single dose to subjects with atopic dermatitis and to healthy subjects.

Registry

clinicaltrials.gov

Start Date

May 2013

End Date

December 2014

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

LEO Pharma

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy subjects or subjects with AD as defined by the Hanifen and Rajka criteria and with at least mild disease activity (IGA \>2) for the whole body
•AD lesions amenable to cutaneous treatment located on the trunk and/or limbs (only for AD subjects)
•Male subjects aged between 18 and 65 years with a body mass index (BMI) between 19.0 and 32.0 kg/m2 inclusive

Exclusion Criteria

•Subjects who currently suffer from, or show signs of eczema or other skin lesions (only for healthy subjects)
•Subjects who are still participating in a clinical trial (e.g. attending follow-up visits) or who have participated in a clinical study involving administration of an investigational product or a marketed drug product within the past 3 months prior to the first dosing occasion.
•Subjects with known immunocompromised state due to treatment with immunosuppressive drugs or due to history of a disease leading to immunocompromised status.
•History of or current cardiac arrhythmic disorder
•Subjects with a current active malignancy or a history of malignancy in remission for less than 5 years except excised skin (not melanoma) and cervical cancer.
•Subjects who have any clinically significant allergic disease (excluding non- active hayfever) as determined by the Investigator

Arms & Interventions

LEO 39652 cream

Active drug

Intervention: LEO 39652 cream

LEO 39652 cream vehicle

Placebo drug

Intervention: cream vehicle

Outcomes

Primary Outcomes

Number of subjects with adverse events and change from baseline in vital signs (blood pressure, pulse rate) ECG, clinical laboratory and local tolerability assessments

Time Frame: Up to 48 hours after dosing