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The purpose of this phase I study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HRS-8797 in healthy participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| single ascending dose (SAD) cohorts | Experimental | Subjects will be assigned to one of 5-6 planned dose cohorts and receive single dose of HRS-8797 or placebo |
|
| multiple ascending dose (MAD) cohorts | Experimental | Subjects will be assigned to one of 3 planned dose cohorts and receive multiple doses of HRS-8797 or placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-8797 | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety: incidence of adverse event (AE), serious adverse event (SAE) | Day1-Day15 (SAD)ï¼›Day1-Day15 (FE)ï¼›Day1-Day21 (MAD) |
| Measure | Description | Time Frame |
|---|---|---|
| PK parameter of HRS-8797 : Area under the concentration time curve (AUC) | Days 1-19 | |
| PK parameter of HRS-8797: Maximum Plasma Concentration (Cmax) | Days 1-19 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Beibei Xu | Contact | +86 0518-82342973 | beibei.xu.bx53@hengrui.com | |
| Hongda Lin | Contact | +86 0518-82342973 | hongda.lin@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Hospital of Jilin University | Changchun | Jilin | 130000 | China |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| Placebo | Drug | Specified dose on specified days |
|
| PK parameter of HRS-8797 : Time to maximum plasma concentration (Tmax) |
| Days 1-19 |
| PK parameter of HRS-8797 : Apparent clearance (CL/F) | Days 1-19 |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |