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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
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.
Details
| Lead sponsor | LEO Pharma |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 23 |
| Start date | 2013-05 |
| Completion | 2014-12 |
Conditions
- Atopic Dermatitis
Interventions
- LEO 39652 cream
- cream vehicle
Primary outcomes
- 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
Countries
United Kingdom