Pharmacokinetics of ATI-50001 in Healthy Subjects (QCL117889)
Research type
Research Study
Full title
A Phase 1, Single-Part, Open-Label, Sequential, Five Period Crossover Study Designed to Evaluate the Pharmacokinetic Profile of ATI-50001 Following Single Dose Administration of Oral Formulations in Comparison to a Reference Immediate Release ATI-50001 Formulation in Healthy Subjects
IRAS ID
218124
Contact name
Sue Moran
Contact email
Sponsor organisation
Aclaris Therapeutics International Limited
Eudract number
2016-004528-51
Duration of Study in the UK
0 years, 1 months, 30 days
Research summary
The Sponsor is developing the study drug, ATI-50001, for the potential treatment of Alopecia areata (AA).\n \nAlopecia is a general term for hair loss. AA is a common cause of non-scarring (does not cause scarring to the scalp) hair loss that typically occurs in childhood or early adulthood. It usually causes round patches of baldness on the scalp, although hair elsewhere such as the beard, eyebrows, eyelashes, body and limbs can be affected. In some people larger areas are affected and occasionally it can affect the whole scalp (alopecia totalis, AT) or even the entire body and scalp (alopecia universalis, AU).\n\nAA is an autoimmune condition. Your body’s immune system protects you from disease and infection, but if you have an autoimmune condition or disease, your immune system attacks healthy cells in your body by mistake.\n \nCurrently there is no proved treatment for AA. Common unproven treatments for less severe (patchy) forms of AA include steroid creams or injection. A recent breakthrough in the understanding of what causes AA has led to the development of ATI-50001 which, from data already collected, is strongly suggested to be an effective treatment of AT and AU.\n\nThis study will consist of 5 study periods involving up to 16 healthy male and female volunteers not of child-bearing potential (post-menopausal or sterile). Volunteers will receive 5 doses of up to 500 mg of ATI-50001 on 5 separate occasions.
REC name
Wales REC 1
REC reference
17/WA/0016
Date of REC Opinion
23 Feb 2017
REC opinion
Further Information Favourable Opinion