Safety, Tolerability, Pharmacokinetics (including Food Effect) of Single Ascending Doses of SAR441121 in healthy male subjects.

This is a Phase 1 clinical trial testing a new experimental drug called SAR441121, which is being developed as a potential treatment for malaria. The study is being conducted in healthy male volunteers to establish for the first time how the human body absorbs, distributes, and eliminates this drug, and to confirm it is safe at different dose levels. The study will also look at whether eating before taking the drug affects how the body processes it. Participants will receive single increasing doses of SAR441121 in a controlled clinical setting, with careful monitoring of vital signs, ECG, and blood tests throughout. The information gathered will help determine safe dose ranges for future trials in malaria patients. This study is open to healthy men aged 18–49 with a normal body weight and no significant health conditions. Women are not eligible for this particular study. People with a history of substance abuse, cardiovascular disease, psychiatric illness, or who are currently taking medications are generally not eligible.