Safety, tolerability, pharmacokinetics and efficacy of ZPL-5212372
Research type
Research Study
Full title
A RANDOMISED, ADAPTIVE DESIGN, DOUBLE BLIND (3RD PARTY OPEN), PLACEBO CONTROLLED, SEQUENTIAL GROUP STUDY TO DETERMINE THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND EFFICACY OF TWICE DAILY APPLICATION OF A TOPICAL ZPL-5212372 (1.0% W/W) OINTMENT ADMINISTERED FOR UP TO 2 WEEKS IN ADULT HEALTHY VOLUNTEERS AND PATIENTS WITH MODERATE TO SEVERE ATOPIC DERMATITIS
IRAS ID
204406
Contact name
Peter Dewland
Contact email
Sponsor organisation
Ziarco Pharma Ltd
Eudract number
2016-000376-26
Duration of Study in the UK
0 years, 6 months, 31 days
Research summary
ZPL-5212372 is a new ointment being developed as a potential treatment for patients with moderate to severe atopic dermatitis.
Atopic dermatitis is a skin condition also known as eczema which is an inflammation of the skin which results in dry, itchy, red, swollen and cracked skin which can cover some of or all of the body.
The main purpose of this study is to look at the safety and tolerability of the ointment in both healthy volunteers and patients, to look at how much of the study drug (ZPL-5212372) goes through the skin into the blood stream and also whether the ointment improves atopic dermatitis in patients.
The ointment is investigational which means that the ointment is still under test and has not been approved for marketing by the Medicines and Healthcare Products Regulatory Agency (MHRA), or other European Regulatory Agencies.
This is the first time the drug is being given as an ointment to humans but the drug in it has previously been tested in humans as an inhaled powder as a potential treatment for asthma. Before any dosing in humans this drug has been tested in animals as an inhaled dry powder, an ointment onto the skin and as an injection under the skin. The concentration of drug in the ointment selected for this study is 3 times lower than the concentration tested in animals on the skin which showed no effects.
All information about you will be kept anonymous. Information may be used in reports of the study or for scientific presentations but will not identify you in any way. Ziarco may also use the information from this study for future medical research, but again, it will not identify you personally.REC name
South Central - Berkshire Research Ethics Committee
REC reference
16/SC/0195
Date of REC Opinion
3 May 2016
REC opinion
Favourable Opinion