Phase 1 Study of INCA033989 Safety and Pharmacokinetics Given by Injection or IV Infusion in Healthy Adults Aged 18 to 55

What this Trial Is About

Researchers are studying the drug INCA033989 to understand how it behaves in the body, its safety, and how well healthy adults tolerate it when given by injection under the skin or into a vein. This Phase 1 trial involves healthy adult participants aged 18 to 55 years with no significant medical history. The study aims to compare the drugs levels in the body when given by different methods and monitor any side effects that may arise. Participants will receive a single dose of INCA033989 either as a subcutaneous injection or an intravenous infusion. Some groups may receive INCA033989 combined with a bioavailability enhancer to assess its effects. The trial includes several cohorts, each receiving the treatment according to a defined protocol. The drug administration will take place once, and the study will follow participants for up to 12 weeks to evaluate pharmacokinetics and safety. During the study, participants will undergo evaluations including clinical exams, laboratory tests, vital signs, and ECGs to monitor their health and response to the drug. Researchers will measure key pharmacokinetic parameters such as peak concentration and overall drug exposure after dosing. Safety will be assessed by recording any treatment-emergent adverse events. Participants must comply with study procedures and restrictions, including avoiding pregnancy and certain medications. The total participation time can last up to 12 weeks.

A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of INCA033989 Following Subcutaneous or Intravenous Administration in Healthy Adult Participants