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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 75mg group | Experimental | 15mg/tablet. Five tablets (75mg) each time. Participants will receive a single dose of Hemay005 tablet in Day 1 followed by twice a day of Hemay005 tablet in Day 3~Day8 and single dose in Day9. |
|
| 90mg group | Experimental | 15mg/tablet. Six tablets (90mg) each time. Participants will receive a single dose of Hemay005 tablet in Day 1 followed by twice a day of Hemay005 tablet in Day 3~Day8 and single dose in Day9. |
|
| 105mg group | Experimental | 15mg/tablet. Seven tablets (105mg) each time. Participants will receive a single dose of Hemay005 tablet in Day 1 followed by twice a day of Hemay005 tablet in Day 3~Day8 and single dose in Day9. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hemay005 | Drug | oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse events (AEs), related AEs and serious AEs (SAEs) | All subjects who receive the drug will be analyzed for safety, and the safety evaluation will refer to CTCAE 5.0 standard. | From Day 1 to Day 11 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen Memorial Hospital of Sun Yat-sen University | Guangzhou | China |
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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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