This phase 1 first-in-human study was designed to assess the safety, tolerability, and pharmacokinetics of single and multiple doses of EI1071 when administered to healthy adult volunteers. This was a randomized, double-blind, placebo-controlled, ascending dose, multi-cohort trial. The study was conducted in two phases: a single ascending dose (SAD) phase, followed by a multiple ascending dose (MAD) phase. Approximately 58 healthy volunteers enrolled in SAD and MAD cohorts (34 in SAD; 24 in MAD). In SAD, participants in Cohorts 1 to 5 received one dose of EI-1071 or placebo. In MAD, participants in Cohorts 1 and 2 received multiple doses of EI-1071 or placebo for 14 consecutive days. Safety, tolerability, and PK profile of EI-1071 were assessed.
This was a first-in-human study to determine the safety, tolerability, and pharmacokinetics of EI1071 after single and multiple doses in healthy volunteers.