Phase 1 Study to Test Safety, Tolerability, and Effects of Oral FB418 in Healthy Adults and Elderly

What this Trial Is About

Researchers are evaluating the safety, tolerability, and how the body processes pharmacokinetics and pharmacodynamics a drug called FB418 in healthy adults and elderly individuals. This Phase 1 trial involves healthy people aged 19 and older, including a specific group of elderly participants, to understand how different doses affect safety and drug behavior in the body. The study has two parts Part A tests single increasing oral doses of FB418 in both healthy adults and elderly subjects, including examining how a high-fat meal affects the drugs absorption. Part B involves giving multiple increasing oral doses to healthy adults to further assess safety and drug behavior. Both parts include a placebo group for comparison, and dosing schedules are carefully controlled and monitored. Participants will undergo screening to confirm health status and eligibility, followed by dosing and monitoring periods lasting from a few days up to two weeks after the last dose. Researchers will measure adverse events and detailed drug levels in the body up to 72 hours after dosing. Safety assessments include physical exams, blood tests, ECGs, and neurological evaluations. The studys total duration per participant varies according to dosing and follow-up requirements.

A Phase 1, SAD and MAD Study to Evaluate the Safety and Tolerability of FB418