Multiple Ascending Dose Study to Assess Safety and Pharmacokinetics of Hemay005 In Healthy Subjects
NCT04837235 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12
Last updated 2024-03-06
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.
Conditions
Interventions
- DRUG
-
Hemay005
oral
Sponsors & Collaborators
-
Tianjin Hemay Pharmaceutical Co., Ltd
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2021-04-29
- Primary Completion
- 2021-08-01
- Completion
- 2021-08-25
Countries
- China
Study Locations
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