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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Drug: LEO 39652 cream
* Drug: cream vehicle


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LEO 39652 cream<br>Active drug | Drug: LEO 39652 cream<br> <br> |
| Placebo Comparator: LEO 39652 cream vehicle<br>Placebo drug | Drug: cream vehicle<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LEO 39652 and metabolites in blood |  | Up to 48 hours after dosing |