Soon a clinical trial will start at ICON with a new compound that may potentially be used for the treatment of autoimmune and inflammatory diseases. The study compound is an antibody that works by binding to a specific antibody type in the blood. Antibodies are proteins which are a part of the immune system. They can detect foreign and harmful substances such as bacteria which can then be cleaned up by other immune cells. In the case of an autoimmune disease, antibodies cannot tell the difference anymore between cells of the body and foreign cells or substances. Antibodies also play a large role in inflammatory diseases.
In this study we will investigate how safe the new compound is and how well it is tolerated when it is used by healthy subjects.
We also investigate how quickly and how well the study compound is absorbed, and what the effects are of the study compound on the body. In addition we look at the effects of the study compound on the immune system.
We compare the effects of the study compound with the effects of a placebo. A placebo is a compound without any active ingredient. The placebo in this study is saline (salt water). Please note that when the term ‘study compound’ is used in this document, we mean study compound, placebo, or both.
The study compound has not been administered to humans before. It has been extensively tested in the laboratory and on animals. The study compound will be tested at various doses.
This trial is not intended to improve your health but is necessary for the further development of this compound. The trial will only take place after it has been approved by the Independent Ethics Committee (METC) or the Central Committee on Research Involving Human Subjects (CCMO).