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Completed

NCT Number: NCT01423656

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

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.

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Covance Clinical Research Unit Ltd.

Leeds, LS2 9LH, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LEO 29102

Drug

Placebo

Drug

Placebo Comparator: LEO 29102 vehicle

Primary outcomes

  1. 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

Secondary outcomes

  1. LEO 29102 and metabolites in blood and urine

    Time frame: 72 hours after dosing

Sponsors and collaborators

Lead sponsor

LEO Pharma

Industry

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Aug 26, 2011
Registry last updated
Feb 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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