Multiple Ascending Dose Study to Assess Safety and Pharmacokinetics of Hemay005 In Healthy Subjects

Summary

Hemay005 is a novel phosphodiesterase type 4(PDE4) inhibitor being developed for the treatment of psoriasis. A total of approximately 24 subjects will be randomized into 3 cohorts(15mg, 30mg, 60mg), approximately 8 healthy subjects will be enrolled (6 active and 2 placebo) at each dose cohort. This study includes an 28-day Screening Period, a 1-day single dose and 7-days multiple doses Treatment Period, and an End of Study Visit occurring approximately 11days (±3 days) after study drug administration.

Timeline

Start

2018-07-10

Primary completion

2018-10-20

Completion

2018-12-01

Publications

• Li X, Wu X, Huo A, Zeng G, Jones R, Chen R, Wang H. Safety, Tolerability, and Pharmacokinetics of Mufemilast, a PDE4 Inhibitor, in Healthy Participants: A First-in-Human Phase 1 Study. Clin Pharmacol Drug Dev. 2026 Jan;15(1):e70005. doi: 10.1002/cpdd.70005.

Drugs

Indications