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

Phase 1

Completed

• Conditions: Atopic Dermatitis
• Interventions: Drug: LEO 29102; Drug: Placebo

• Registration Number: NCT01423656
• Lead Sponsor: LEO Pharma

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-07-14
• Study Start: 2011-08
• Study First Submitted QC: 2011-08-25
• Study First Posted: 2011-08-26
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Status Verified: 2013-01
• Last Update Submitted: 2025-02-21
• Last Update Posted: 2025-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LEO 29102	LEO 29102	-
LEO 29102 vehicle	Placebo	-

Primary Outcome Measures

Name	Time	Method
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	7 days after last dosing

Secondary Outcome Measures

Name	Time	Method
LEO 29102 and metabolites in blood and urine	72 hours after dosing

Trial Locations

Locations (1)

Covance Clinical Research Unit Ltd.; 🇬🇧 Leeds, United Kingdom