Safety, Tolerability and Pharmacokinetics in AD Subjects and Healthy Subjects of Cutaneous Application of LEO 39652 Cream

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01850849

Enrollment

Registered

2013-05-10

Start date

2013-05-31

Completion date

2014-12-31

Last updated

2025-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis

Brief summary

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.

Interventions

DRUGLEO 39652 cream

DRUGcream vehicle

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

MALE

Age

18 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy subjects or subjects with AD as defined by the Hanifen and Rajka criteria and with at least mild disease activity (IGA \>2) for the whole body * AD lesions amenable to cutaneous treatment located on the trunk and/or limbs (only for AD subjects) * Male subjects aged between 18 and 65 years with a body mass index (BMI) between 19.0 and 32.0 kg/m2 inclusive

Exclusion criteria

* Subjects who currently suffer from, or show signs of eczema or other skin lesions (only for healthy subjects) * Subjects who are still participating in a clinical trial (e.g. attending follow-up visits) or who have participated in a clinical study involving administration of an investigational product or a marketed drug product within the past 3 months prior to the first dosing occasion. * Subjects with known immunocompromised state due to treatment with immunosuppressive drugs or due to history of a disease leading to immunocompromised status. * History of or current cardiac arrhythmic disorder * Subjects with a current active malignancy or a history of malignancy in remission for less than 5 years except excised skin (not melanoma) and cervical cancer. * Subjects who have any clinically significant allergic disease (excluding non- active hayfever) as determined by the Investigator

Design outcomes

Primary

Measure	Time frame
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

Secondary

Measure	Time frame
LEO 39652 and metabolites in blood	Up to 48 hours after dosing

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026