Leo - 32731 Phase I, Single-Blind, SAD/MAD study in healthy volunteers
Research type
Research Study
Full title
LEO 32731 - A Phase I, Single-Blind, Placebo-Controlled, Single and Multiple Oral Dose, Safety, Tolerability and Pharmacokinetic Study in Healthy Subjects
IRAS ID
172657
Contact name
Ashley Brooks
Contact email
Sponsor organisation
LEO Pharma A/S
Eudract number
2014-003337-25
Duration of Study in the UK
0 years, 2 months, 20 days
Research summary
LEO 32731 is a drug currently developed as oral treatment for atopic dermatitis (AD) and psoriasis. In atopic dermatitis or eczema, the skin becomes extremely itchy and inflamed causing redness, swelling, cracking, weeping, crusting, and scaling. The disease tends to run in families and affects 1-3% of the adult population and 10–20% of children worldwide.
Psoriasis is a multisystem disease with predominantly skin and joint problems, affecting approximately 1 to 3% of the population. It is characterised by scaly plaques which are often itchy. Psoriasis is a disabling disease which may have a significant impact on patients’ overall health-related quality of life.
The study drug (LEO 32731) is a selective phosphodiesterase 4 (PDE4). PDE4 inhibitors are a well characterised class of pharmaceutical agents with a broad range of anti-inflammatory activities. LEO 32731 works by controlling the release of chemicals that play a role in the development of AD and psoriasis, and thus it is hoped that the study drug will be helpful for these patients with few undesirable side effects.
The study drug (LEO 32731) has been tested in previous clinical trials in different formulations. This study will be performed in 3 parts. In Parts 1 and 2 of this study, multiple, titrated (gradually increasing dose levels) oral doses of LEO 32731 will be administered to healthy male subjects. The titration will be optimised in Part 2 (selected based on tolerability from Part 1). In Part 3 of this study, single oral doses of LEO 32731 will be administered to healthy female subjects.
Subject participation is expected to last up to 7 weeks in Parts 1 and 2 and up to 5 weeks in Part 3 from the time of screening till the last post-study visit.REC name
South Central - Berkshire B Research Ethics Committee
REC reference
15/SC/0329
Date of REC Opinion
30 Jun 2015
REC opinion
Further Information Favourable Opinion