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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hemay005 | Experimental | 6 subjects in each cohort(15mg, 30mg, 60mg) will receive Hemay005 |
|
| Placebo | Placebo Comparator | 2 subjects in each cohort(15mg, 30mg, 60mg) will receive placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hemay005 | Drug | Subjects will be randomized into 3 dose groups orally twice daily. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse events and serious adverse events. | Day1 up to Day20±3 |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Maximum observed plasma concentration | pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48 hours post-dose on day 1 and day11 |
| area under the curve from time zero to the last quantifiable concentration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hongyun Wang, Doctor | Contact | 010-69156576 | wanghy@pumch.cn |
| Name | Affiliation | Role |
|---|---|---|
| Hongyun Wang, Doctor | Peking Union Medical College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Recruiting | Beijing | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41545329 | Derived | 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. |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C000628605 | Hemay005 |
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| Placebo |
| Drug |
Subjects will be randomized into 3 dose groups orally twice daily. |
|
Area under the plasma concentration-time curve from time zero to the last quantifiable concentration
| pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48 hours post-dose on day 1 and day11 |
| area under the curve from time zero extrapolated to infinity | Area under the plasma concentration-time curve from time zero extrapolated to infinity | pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48 hours post-dose on day 1 and day11 |
| t1/2 | Terminal elimination half-life | pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48 hours post-dose on day 1 and day11 |
| clearance CL/F | Apparent total plasma clearance | pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48 hours post-dose on day 1 and day11 |
| Vz/F | Apparent total volume of distribution | pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48 hours post-dose on day 1 and day11 |