The study compound is being developed for the treatment of inflammatory diseases and autoimmune diseases. These are diseases in which the immune system works too hard. Normally, an inflammation helps the body protect itself against infections or injuries. But in inflammatory diseases, this response continues for too long, even when there is no real threat anymore. Autoimmune diseases are a type of inflammatory disease. In these diseases, the immune system makes a mistake and attacks the body itself instead of invaders. Examples of inflammatory and autoimmune diseases are rheumatoid arthritis and Crohn’s disease.
In this clinical trial we will investigate how safe the study compound is and how well it is tolerated. We will also investigate how quickly and to what extent the study compound is absorbed, transported, and eliminated from the body. Furthermore, we will investigate whether the study compound has an effect on heart rhythm. We do this by using a heart recording (ECG) to measure how the heart recovers between two heartbeats.
We compare the effects of the study compound with the effects of a placebo and moxifloxacin. A placebo is a compound without any active ingredient. Moxifloxacin is an approved antibiotic and is already available on the market (antibiotics are medicines that kill harmful bacteria in the body or stop their growth).
You will receive the study compound and placebo as capsules and moxifloxacin as tablets by mouth. During 4 separate periods, you will receive the study compound a total of two times, and the placebo and moxifloxacin each once (1 dose per period).
The compound has already been tested in healthy individuals and patients with autoimmune diseases. In these clinical trials, the following side-effects were observed most often: headache, and a higher risk of infections. In infections, viruses, bacteria, fungi, or parasites (so-called ‘pathogens’) enter the body and begin to grow there. If the immune system is weakened, a person can then become ill. You may also experience other, yet unknown, side effects. Prior to the medical screening, you will receive written information about the trial, which also describes the possible side effects. This information will also be discussed with you at the start of the medical screening. You can then ask the screening physician or nurse any questions you may have. Once everything is clear to you, you can decide whether to give written consent to participate in the trial. The medical screening will only take place after you have given written consent to participate in the trial. We want to emphasize that even after giving written consent, participation in any clinical trial is voluntary. You can decide at any time not to participate or to stop the medical screening or the trial. You do not need to provide a reason for why you no longer wish to participate.
