Safety, Tolerability and Pharmacokinetics in AD Subjects and Healthy Subjects of Cutaneous Application of LEO 39652 Cream

Phase 1

Completed

• Conditions: Atopic Dermatitis
• Interventions: Drug: cream vehicle; Drug: LEO 39652 cream

• Registration Number: NCT01850849
• Lead Sponsor: LEO Pharma

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-05-07
• Study First Submitted QC: 2013-05-09
• Study First Posted: 2013-05-10
• Primary Completion: 2014-11
• Study Completion: 2014-12
• Status Verified: 2015-01
• Last Update Submitted: 2025-02-21
• Last Update Posted: 2025-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 23

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LEO 39652 cream vehicle	cream vehicle	Placebo drug
LEO 39652 cream	LEO 39652 cream	Active drug

Primary Outcome Measures

Name	Time	Method
Number of subjects with adverse events and change from baseline in vital signs (blood pressure, pulse rate) ECG, clinical laboratory and local tolerability assessments	Up to 48 hours after dosing

Secondary Outcome Measures

Name	Time	Method
LEO 39652 and metabolites in blood	Up to 48 hours after dosing

Trial Locations

Locations (2)

Covance Clinical Research Unit, Hyde Street, Leeds, UK; 🇬🇧 Leeds, United Kingdom

Covance Royal Liverpool Clinical Research Unit; 🇬🇧 Liverpool, United Kingdom