LEO 29102 topical application SAD/MAD study

• Research type

  Research Study

• Full title

  LEO 29102 - A Phase I, Single-Blind, Vehicle Controlled, Single and Multiple Dose Safety, Tolerability and Pharmacokinetic Study in Healthy Subjects by dermal application of a LEO 29102 20 mg/ml cutaneous solution

• IRAS ID

  83726

• Sponsor organisation

  LEO Pharma A/S

• Eudract number

  2011-001536-30

• Research summary

  LEO 29102 is an investigational drug which is being developed by LEO Pharma A/S with an aim to help people with a condition affecting the skin in some people, called atopic dermatitis (AD).This study has been designed to look at how safe and well tolerated this study drug is following ascending single and multiple cutaneous doses of LEO 29102 20 mg/ml cutaneous solution to healthy subjects, and to measure how much of the drug gets into the blood stream and how long it takes the body to remove it. The study will furthermore compare the safety and how much the drug is absorbed into the blood stream between healthy male and female subjects.The study will be conducted in three parts. During part 1 of the Study, up to 40 healthy male volunteers will be studied in 5 groups. This part of the study will comprise an ascending single dose of LEO 29102. For part 2, 8 healthy female subjects will be studied in a single group to investigate gender effect, and a single dose of the study drug will be given. Part 3 will comprise an ascending multiple dose, sequential group study in 24 healthy male subjects, studied in 3 groups.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  11/IE/0116

• Date of REC Opinion

  21 Jul 2011

• REC opinion

  Favourable Opinion