Effects of hrAnx-A1 in healthy men, v1
Research type
Research Study
Full title
A clinical pharmacology study of human recombinant Annexin-A1 (hrAnx-A1) in healthy subjects (15-023).
IRAS ID
206454
Contact name
Malcolm Boyce
Contact email
Sponsor organisation
TRIO Medicines Ltd
Eudract number
2000-123456-78
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Annexin A-1 (Anx-A1) is a naturally occurring substance, present in the blood and many other parts of the body. Anx-A1 is involved in controlling inflammation – the body’s protective response to injury or infection.
We’ve made Anx-A1 in the laboratory (hrAnx-A1). It’s identical to naturally occurring human Anx A1. We want to test it in healthy volunteers, to find out its side effects, blood levels and effects on other substances linked to inflammation. The results might help us make new anti-inflammatory medicines.
We’ll give healthy men, aged 18–55, injections of hrAnx-A1 into a vein in the arm or under the skin of the abdomen.
The study is in 2 parts:
* Part A – up to 27 men will receive up to 4 single doses of hrAnx-A1. It’s never been given to humans before, so we’ll start with a small dose, and increase the dose as the study progresses. Participants will take up to 15 weeks to finish the study. They’ll make 2 outpatient visits, and have up to 4 stays on the ward of 2–3 nights each.
* Part B – we plan to give 9 men 5 daily doses of hrAnx-A1, but we’ll choose the dose and the gaps between doses, based on the results from Part A. Participants will take up to 6 weeks to finish the study. They’ll make 2 outpatient visits, and stay on the ward for 7 nights.
A pharmaceutical company (Trio Medicines) is funding the study.
The study will take place at 1 centre in London.
REC name
London - Harrow Research Ethics Committee
REC reference
16/LO/1122
Date of REC Opinion
22 Aug 2016
REC opinion
Further Information Favourable Opinion