Investigating the anti-inflammatory effects of Annexin A1 in humans vA
Research type
Research Study
Full title
An exploratory study investigating the effect and the mechanism of action of human recombinant Annexin A1 (hrAnx-A1) in a human model of sepsis (17-016)
IRAS ID
240416
Contact name
Frans van den Berg
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-A1 (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. Too much inflammation can lead to illnesses, such as hay fever, asthma and rheumatoid arthritis.
We’ve made human recombinant (hr) Anx-A1 in the laboratory. It’s identical to naturally occurring human Anx-A1. We want to test it in healthy men to find out its effects on inflammation. We’ll also assess its side effects and blood levels. The results might help us make new anti-inflammatory medicines.
We’ll enrol 18 healthy men, aged 18–40 years. So we can investigate the effects of hrAnx-A1 on inflammation, first we’ll give participants a small dose of a substance called lipopolysaccharide (LPS), by injection into a vein in the arm. Injecting a small dose of LPS mimics the early stages of an infection, and triggers the body’s inflammatory response. Participants will then receive a single dose of hrAnx-A1 by injection into a vein in the arm.
Participants will take about 2 weeks to finish the study. They’ll make 2 outpatient visits, and stay on the ward for 2 nights.
A pharmaceutical company (Trio Medicines Ltd) is funding the study.
The study will take place at 1 centre in London.
REC name
London - Brent Research Ethics Committee
REC reference
18/LO/0083
Date of REC Opinion
9 Mar 2018
REC opinion
Further Information Favourable Opinion