A Phase 1 Single Dose Study to Assess the Pharmacokinetics and Safety of the Biosimilar Ustekinumab Healthy Volunteers

Ustekinumab is an established medication used to treat conditions like psoriasis, Crohn's disease, and ulcerative colitis. This Phase 1 clinical study is testing a potential biosimilar version of ustekinumab — a medication called Neulara that is designed to work in the same way but may be manufactured differently. Biosimilars are important because they can make effective medications more affordable and accessible. The study will compare how Neulara behaves in the body compared to the original ustekinumab — specifically, how it is absorbed, distributed, and eliminated (pharmacokinetics). A single dose will be given by injection to healthy volunteers, who will then have blood samples taken at regular intervals to track drug levels. Safety and tolerability will also be carefully monitored throughout. You may be eligible if you are a healthy adult aged 18 to 55, have a BMI between 17 and 32, weigh between 50 and 100 kg, and have no significant medical conditions or chronic illnesses. People with previous exposure to ustekinumab, a history of cancer, serious allergies, recent infections, or a positive test for HIV, hepatitis B, or C are not eligible. This is a healthy volunteer study offering compensation for time and travel.