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This is a Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Single and Multiple AscendingDose Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ICP-488 in Healthy Subjects and Patients With Psoriasis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ICP-488 | Experimental | Single ascending doses of ICP-488 tablet; Multiple ascending doses of ICP-488 tablet; Part3 Patients with Psoriasis:ICP-488 tablet. |
|
| Placebo | Placebo Comparator | Single ascending doses of placebo; Multiple ascending doses of placebo; Part3 Patients with Psoriasis of placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ICP-488 | Drug | ICP-488 will be administered as tablet |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of adverse events during treatment, and withdrawal from treatment due to adverse events | Single ascending dose: 1day;Multiple ascending dose: 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Single ascending dose: 1day;Multiple ascending dose: 28 days | |
| Psoriasis Area and Severity Index (PASI) | Day1,Day7,Day14,Day21,Day28,Day35,Day42,Day56 | |
| Body Surface Area (BSA) |
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Inclusion Criteria:
1)Psoriasis Area and Severity Index (PASI) ≥ 12; 2)Physician Global Assessment (PGA) ≥ 3; 3)Body surface area (BSA) affected by psoriasis ≥ 10%.
8. The subject is a candidate to receive systemic therapy and/or phototherapy.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lisa Zhao | Contact | +86 18233150939 | Lisa.zhao@innocarepharma.com |
| Name | Affiliation | Role |
|---|---|---|
| Qianjin Lu | Hospital for Skin Diseases, Chinese Academy of medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Hospital of Anhui Meidcal University | Not yet recruiting | Hefei | Anhui | 230601 | 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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| Drug |
Matching placebo will be administered as tablet |
|
| Day1,Day7,Day14,Day21,Day28,Day35,Day42,Day56 |
| Static Physician's Global Assessment (sPGA) | Day1,Day7,Day14,Day21,Day28,Day35,Day42,Day56 |
| Peak Pruritus Numerical Rating Scale (PP-NRS) | Day1-Day14, Day21, Day28, Day35, Day42, Day56 |
| Dermatology quality of life index (DLQI) | Day1,Day7,Day14,Day21,Day28,Day35,Day42,Day56 |
| The First Hospital of Hebei Medical University | Not yet recruiting | Shijiazhuang | Hebei | 050000 | China |
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| Nanyang First People's Hospital | Not yet recruiting | Nanyang | Henan | 473004 | China |
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| Shiyan Renmin Hospital | Recruiting | Shiyan | Hubei | 442000 | China |
|
| Hospital for Skin Diseases, Institute of Dermatology, Chinese Academy of medical Sciences, Peking Union Medical College | Recruiting | Nanjing | Jiangsu | 210000 | China |
|
| Yanbian University Hospital | Not yet recruiting | Yanji | Jilin | 133000 | China |
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| Hangzhou First People's Hospital | Not yet recruiting | Hangzhou | Zheajing | 310006 | China |
|