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Hemay005 is a novel phosphodiesterase type 4(PDE4) inhibitor being developed for the treatment of psoriasis. This study is the first administration of Hemay005 in humans to establish the initial safety, tolerability, and pharmacokinetic profile following single doses of Hemay005. A total of approximately 44 subjects will be randomized into 6 cohorts(10mg, 20mg, 40mg, 80mg, 120mg, 180mg), approximately 8 healthy subjects will be enrolled (6 active and 2 placebo) at each dose cohort by sentinel method(1 active and 1 placebo,5 active and 1 placebo), with the exception of 10mg (4 active) cohort. This study includes an 28-day Screening Period, a 1-day 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 | Four subjects in cohort 1 and six subjects in each cohort (2 to 6) will receive Hemay005. |
|
| Placebo | Placebo Comparator | Two subjects in each cohort (cohorts 2 to 6) will receive placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hemay005 | Drug | Subjects will be randomized into 6 cohorts(10mg, 20mg, 40mg, 80mg, 120mg, 180mg) orally single dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse events and serious adverse events | Day 1 up to Day 11±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 |
| Tmax | Time of maximum concentration |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Beijin | 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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| Placebos | Drug | Subjects will be randomized into 5 cohorts(20mg, 40mg, 80mg, 120mg, 180mg) orally single dose |
|
| pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48 hours post-dose |
| AUCt | 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 |
| AUC∞ | 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 |
| t1/2 | Terminal elimination half-life | pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48 hours post-dose |
| CL/F | Apparent total plasma clearance | pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48 hours post-dose |
| 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 |
| Cumulative urinary excretion | pre-dose, 0-4 hours,4-8 hours,8-12 hours,12-24 hours,24-36 hours,36-48 hours post-dose |
| Accumulative urine excretion rate | pre-dose, 0-4 hours,4-8 hours,8-12 hours,12-24 hours,24-36 hours,36-48 hours post-dose |
| Renal clearance | pre-dose, 0-4 hours,4-8 hours,8-12 hours,12-24 hours,24-36 hours,36-48 hours post-dose |