This is a Phase 1, single-center, randomized, single-blind, placebo-controlled single ascending doses/multiple ascending oral doses (SAD/MAD) study in healthy adult volunteers (HV). The Sponsor plans to enroll up to 60 healthy adult male and female volunteers in total irrespective of their race and ethnicity. The enrollment period is 6 months. But this period may be extended to complete the target enrollment. The study will follow a 4 + 4 design.~The SAD section will consist of six cohorts of four participants (3 treatment + 1 placebo) in each cohort (Total 24 HV). Additional cohorts may be added. The subjects in the SAD section are given a single oral dose and followed up for 14 days.~The MAD portion of the study will comprise of three cohorts of four participants (3 treatment + 1 placebo) in each cohort (Total 12 HV). The participants are dosed daily for 14 days. Additional cohorts may be added. Each MAD cohort will be initiated only after a SAD cohort at a dose level higher than the planned MAD cohort has been cleared. The subjects in the MAD section are given the drug orally once daily for 14 days and followed up for 3 months.
A Phase I First-in-Human, Randomized, Single-Blind, Placebo-Controlled Study in Healthy Adult Volunteers to Evaluate Safety, Tolerability, and Pharmacokinetics after Single and Multiple Oral Doses of LPX-TI641.