APL-1 SAD/ MAD study in healthy subjects
Research type
Research Study
Full title
An open-label, randomised, placebo-controlled, dose escalation study to investigate the safety, tolerability and pharmacokinetics of single and multiple inhaled doses of APL-1 in healthy subjects
IRAS ID
126569
Contact name
James Ritter
Contact email
Sponsor organisation
Apellis Pharmaceuticals Inc
Eudract number
2012-004838-42
Research summary
This will be the first time APL-1 has been given by inhalation to humans, although this drug is also being investigated as a possible treatment for diseases of the eye, and small doses have been administered into the eyes of patients with eye disease. APL-1 inhibits complement, a body defense mechanism that, if overactive, contributes to the progression of several diseases, including lung disorders such as asthma and bronchitis. A preparation for inhalation is being developed by Apellis Pharmaceuticals (the Sponsor, a biotechnology company based in Kentucky, USA). The present study is to be carried out on behalf of the Sponsor by Quintiles, and its purpose is to examine the safety, tolerability and the way the body handles (absorbs, distributes, breaks down and excretes) various single and multiple inhaled doses of APL-1 in healthy young persons. This information will be used to plan its subsequent investigation in patients with lung disorders.
REC name
London - London Bridge Research Ethics Committee
REC reference
13/LO/0527
Date of REC Opinion
24 Jun 2013
REC opinion
Further Information Favourable Opinion