Safety, Tolerability and Pharmacokinetic Study in Healthy Subjects by Dermal Application of a LEO 29102

LEO Pharma1 site in 1 country102 target enrollmentAugust 2011

ConditionsAtopic Dermatitis

InterventionsLEO 29102 Placebo

DrugsLEO 29102 Placebo

Overview

Phase: Phase 1
Intervention: LEO 29102
Conditions: Atopic Dermatitis
Sponsor: LEO Pharma
Enrollment: 102
Locations: 1
Primary Endpoint: Number of subjects with adverse events (AEs) and change from baseline in vital signs (blood pressure, pulse rate, respiratory rate and oral body temperature), ECG, telemetry,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 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 subjects.

The study is divided into one single dose part, one part to compare pharmacokinetics between gender and one multiple dose part.

Registry

clinicaltrials.gov

Start Date

August 2011

End Date

November 2012

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

LEO Pharma

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects will be Caucasian males and females between 18 and 55 years of age and with a body mass index (BMI) between 18.0 and 30.0 kg/m2 inclusive.
•Subjects must be in good health, as determined by a medical history, physical examination, 12-lead electrocardiogram (ECG) and clinical laboratory evaluations

Exclusion Criteria

•Subjects who suffer from, or show signs of eczema or other skin lesions.
•Subjects who are still participating in a clinical study (e.g. attending follow-up visits) or who have participated in a clinical study involving administration of an investigational drug (new chemical entity), or a marketed drug within the past 3 months prior to the first dosing occasion.
•Subjects with a significant history of drug allergy as determined by the Investigator.
•Subjects with known immunocompromised state due to treatment with immunosuppressive drugs or due to history of a disease leading to immunocompromised status.

Arms & Interventions

LEO 29102

Intervention: LEO 29102

LEO 29102 vehicle

Intervention: Placebo

Outcomes

Primary Outcomes

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

Time Frame: 7 days after last dosing