A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study of RZ-629 to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Healthy Subjects
A total of 50 healthy subjects will be allocated to 5 groups in the SAD study. Each group includes 10 subjects (8 subjects will receive RZ-629 and 2 receive placebo). All subjects will check-in on the day before the administration (Day -1) and on Day 1. Each subject in fasted state will be randomly assigned to receive a single oral dose of RZ-629 or placebo. Subjects will remain in the clinical research unit (CRU) through the completion of the safety/tolerability evaluation. The safety review committee (SRC) will review all safety data and blinded summary of available PK data through the safety follow-up and decide to proceed to the next dose level.