LEO 29102 Single and Multiple Dose Study by Dermal Application

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2009-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Atopic Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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1

LEO 29102 2.5 mg/g cream

Group Type EXPERIMENTAL

LEO 29102

Intervention Type DRUG

First-in-man. Healthy volunteers

2

LEO 29102 cream vehicle

Group Type PLACEBO_COMPARATOR

LEO 29102

Intervention Type DRUG

First-in-man. Healthy volunteers

Interventions

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LEO 29102

First-in-man. Healthy volunteers

Intervention Type DRUG

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes