Safety and Pharmacokinetics of Hemay005 In Healthy Male Subjects
Status:
Completed
Trial end date:
2018-06-01
Target enrollment:
Participant gender:
Summary
Hemay005 is a novel phosphodiesterase type 4(PDE4) inhibitor being developed for the
treatment of psoriasis. This study is the first administration of Hemay005 in humans to
establish the initial safety, tolerability, and pharmacokinetic profile following single
doses of Hemay005. A total of approximately 44 subjects will be randomized into 6
cohorts(10mg, 20mg, 40mg, 80mg, 120mg, 180mg), approximately 8 healthy subjects will be
enrolled (6 active and 2 placebo) at each dose cohort by sentinel method(1 active and 1
placebo,5 active and 1 placebo), with the exception of 10mg (4 active) cohort. This study
includes an 28-day Screening Period, a 1-day Treatment Period, and an End of Study Visit
occurring approximately 11days (±3 days) after study drug administration.