Healthy Volunteers Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled Dose-Escalation Phase I Study in Healthy Chinese Adult Subjects to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Characteristics of Etrasimod Following Oral Single and Multiple Doses Administration
The primary objective of the trial is to assess the safety and tolerability of Etrasimod
after single and multiple oral doses administration in healthy Chinese adult subjects.
The Secondary Objective of the trial is to assess PK characteristics of Etrasimod and its
metabolites(M3 and M6)after single and multiple oral doses administration in healthy Chinese
adult subjects; To assess PD characteristics of Etrasimod after single and multiple oral
doses administration in healthy Chinese adult subjects.
There are 3 dose cohorts (1 mg, 2 mg, and 3 mg) in this study. Each dose cohort is planned to enroll 12 subjects randomized to receive Etrasimod or placebo (9 for Etrasimod, 3 for placebo), for a total of 36 subjects are planned in the study. Etrasimod will be administered at doses of 1 mg, 2 mg, and 3 mg in cohort 1, 2, and 3, respectively. ;
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