Status:
COMPLETED
Safety, Tolerability and Pharmacokinetic Study in Healthy Subjects by Dermal Application of a LEO 29102
Lead Sponsor:
LEO Pharma
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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 di...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT01423656
Start Date
August 1 2011
End Date
November 1 2012
Last Update
February 24 2025
Active Locations (1)
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1
Covance Clinical Research Unit Ltd.
Leeds, United Kingdom, LS2 9LH