drugset / Trial / NCT04837235

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

NCT04837235

Phase 1 Completed 12 enrolled Tianjin Hemay Pharmaceutical Co., Ltd
Non-randomizedSequentialOpen-labelTreatment

Summary

Hemay005 is a novel phosphodiesterase type 4(PDE4) inhibitor being developed for the treatment of psoriasis. There were 3 dose cohorts (75mg, 90mg, 105mg) with 12 healthy subjects in each cohorts (6 males and 6 females). This study includes an 11-day Screening Period, a 1-day single dose and 7-days multiple doses Treatment Period.

Timeline

Start
2021-04-29
Primary completion
2021-08-01
Completion
2021-08-25

Drugs

EvaluationDrugModalityDoseRoute
Subject MUFEMILAST Small molecule 75 mg Oral
Subject MUFEMILAST Small molecule 90 mg Oral
Subject MUFEMILAST Small molecule 105 mg Oral

Indications