Safety, blood levels and effects of Coversin, v1
Research type
Research Study
Full title
A multiple ascending dose trial of Coversin in healthy normal volunteers (15-030)
IRAS ID
196889
Contact name
Adeep Puri
Contact email
Sponsor organisation
Akari Therapeutics Plc
Eudract number
2015-005075-24
Duration of Study in the UK
0 years, 10 months, 0 days
Research summary
Coversin (the study medicine) is an experimental new medicine for treating a disease called paroxysmal nocturnal haemoglobinuria (PNH). PNH is a rare blood disorder in which red blood cells are weakened, and the body’s immune system attacks and destroys them. People with PNH don’t have enough red blood cells, so they become dizzy, and often have breakdown products of blood in their urine. It can also lead to other problems, such as blood clots and problems with the kidneys, bone marrow (which makes blood cells) and lungs, and is usually fatal. \n \nWe hope that the study medicine will work by blocking the part of the immune system (called the complement pathway) that attacks PNH red blood cells. It might also be used in the future to treat other diseases involving the immune system.\n\nIn this study, we aim to find out the side effects and blood levels of the study medicine, whether it blocks the complement pathway, and what dose will be effective in patients. We’ll give up to 30 healthy people, aged 18–60 years, daily doses of the study medicine for 5 days, by injection under the skin. We’ll start with a small dose, and increase the dose as the study progresses. Because the study medicine might block part of the immune system, participants will be vaccinated against meningococcal infection before they start the study, and they’ll take antibiotics while they’re taking the study medicine, and for 22 days afterwards. \n\nParticipants will take up to 8 and a half weeks to finish the study. They’ll make up to 9 outpatient visits, and stay on the ward for 7 nights.\n\nA pharmaceutical company (Akari Therapeutics Plc) is funding the study.\n\nThe study will take place at 1 centre in London.
REC name
London - Harrow Research Ethics Committee
REC reference
16/LO/0050
Date of REC Opinion
22 Jan 2016
REC opinion
Favourable Opinion