Healthy Male Volunteers
Study Name: HEALTHY MALE VOLUNTEERS
Clinics: Manchester EPU
Therapy Area: Healthy Volunteers
Gender and Age: Males aged 18 - 55
MAC is currently conducting a new clinical research study for male healthy volunteers.
The purpose of this short study is to test a new drug that is being developed for the treatment of diseases where there is inflammation. This is not the first time this drug has been given to man.
In order to test whether the study drug is effective, this study will use a technique of inducing a blister to see whether treatment with the study drug reduces markers of inflammation in the blister fluid. Two different techniques to make a blister have been proposed for this study; these methods include the application of a small amount of a substance used to treat warts and a method that uses suction applied to your skin. Only one of the methods proposed will be selected for use in this study and will be decided prior to the study start. Following creation of a blister, the blister fluid is then collected and analysed for markers of inflammation. It is not expected that either method will be painful, although mild discomfort and itching is possible.
In this study, there will be 2 treatment periods; you will be administered 6 daily doses of study drug in one treatment period and 6 daily doses of placebo in another treatment period.
The study will last approximately 11 weeks and will involve:
Screening visit, 10 non-residential visits (1 day each) 2 x 1-night residential stay and a follow up visit.
We will notify your GP of your participation and of any information relevant to your healthcare.
Reimbursement: £1530 plus reasonable travel expenses will also be reimbursed.
*Key Inclusion Criteria:
Males aged 18 – 55 years (inclusive)
BMI of 18 – 32 kg/m2 (inclusive) and minimum weight 50kg
Must be in good health as determined by medical and psychiatric history, medical examination, ECG and blood tests
*Key Exclusion Criteria:
Currently using any prescription or non-prescription medications (including supplements)
History of smoking within 3 months of screening visit (e-cigarettes also excluded)
Skin trauma, active skin disorders, scarring or tattoos on the forearms
Eligible patients will receive a comprehensive health screen and study participation will be in agreement with the subject’s GP.