Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Higher Doses of OMS906
Research type
Research Study
Full title
A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Higher Doses of OMS906 by Single Dose Intravenous Administration in Healthy Subjects
IRAS ID
1008854
Contact name
Samantha Magazu
Contact email
Sponsor organisation
Omeros Corporation
ISRCTN Number
ISRCTN16253842
Research summary
Paroxysmal nocturnal haemoglobinuria (PNH) is a rare blood condition where blood cells are attacked and destroyed by the immune system. This can lead to variety of symptoms including blood clots, serious infections and bone marrow failure.\nThe human immune system is the body’s defence mechanism against infections and diseases. The complement system is part of the immune system that uses a group of specialised proteins to fight infection. There are multiple pathways the complement system uses to protect the body, one of which is called the alternative pathway (AP). The AP is activated by viruses, fungi, bacteria and parasites, and forms an important part of the body’s defence mechanism by tagging invading organisms for destruction. However, sometimes this process becomes poorly regulated and the immune system mistakenly attacks and damages parts of its own body, which is known as an autoimmune disease. Autoimmune diseases can trigger the spread of inflammation and tissue destruction within the body. The AP has been implicated in a broad range of autoimmune responses that can lead to kidney failure, heart failure and other serious health problems, resulting in illnesses like PNH. In PNH, uncontrolled activity of the AP results in the destruction of red blood cells causing anaemia.\nTo date there are only a few options to treat PNH. Therefore, we wish to investigate further if OMS906 may help in treating PNH.\nDuring the study, volunteers will be administered a single dose of OMS906 in a supervised clinical setting. \nWe plan to enrol up to 16 healthy volunteers into this study, who will divided into 2 cohorts (8 participants per cohort). During this study they will be infused with a single dose of OMS906 or placebo.
REC name
Wales REC 1
REC reference
23/WA/0330
Date of REC Opinion
11 Jan 2024
REC opinion
Further Information Favourable Opinion