Phase 1 study to assess safety, tolerability and drug levels of MOR106
Research type
Research Study
Full title
A parallel-design Phase 1 study to assess safety, tolerability and pharmacokinetics/exposure following different single dose levels of MOR106 (administered subcutaneously or intravenously) in healthy male subjects (randomized, open-label), and in subjects with moderate to severe atopic dermatitis (randomized, placebo-controlled, double-blind, repeated subcutaneous dosing over 12 weeks).
IRAS ID
246857
Contact name
Niyati Prasad
Contact email
Sponsor organisation
Galapagos NV
Eudract number
2018-000357-44
Duration of Study in the UK
1 years, 0 months, 16 days
Research summary
The study drug called MOR106 is an investigational medication that is being developed for the treatment of Atopic Dermatitis (AD). AD is a chronic condition that causes skin to become itchy, red, dry and cracked. At present, there is no cure for this condition.
The purpose of the study is to look at the safety, tolerability and pharmacokinetics (levels of study drug in the blood and the time it takes for your body to break it down) of MOR106 when given as a subcutaneous injection (injected under the skin) in healthy male participants and males and females with AD. In Part 1 of the study, the levels of MOR106 in the blood when administered subcutaneously will be compared with administration as an intavenous infusion (via a drip into a vein). In Part 2, the effects of MOR106 on Atopic Dermatitis will be assessed.
This study is split into two parts:
o Part 1 will test single doses of MOR106, administered subcutaneously or intravenously in healthy male participants.
o Part 2 will test multiple doses of MOR106, administered subcutaneously in male and female participants with moderate to severe Atopic Dermatitis.Subjects will participate in one part of the study only.
MOR106 is not a licensed medication, i.e. it cannot be prescribed by a GP or doctor, but it has been given to humans before.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
18/SC/0246
Date of REC Opinion
22 Jun 2018
REC opinion
Further Information Favourable Opinion