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The study is being conducted to evaluate the safety and pharmacokinetics of SHR0410 in patients with hemodialysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR0410 | Experimental | Experimental: SHR0410 dose escalation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR0410 | Drug | SHR0410 monotherapy,given intravenously |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]) | Pre-dose to Day13 |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of PK parameter-Area under drug-time curve (AUC0-t) | Pre-dose to Day 6 | |
| Assessment of PK parameter-Area under drug-time curve (AUC0-∝) | Pre-dose to Day 6 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jianjun Zou | Jiangsu HengRui Medicine Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongda Hospital Affiliated to Southeast University | Nanjing | Jiangsu | 210009 | China |
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| ID | Term |
|---|---|
| D011537 | Pruritus |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
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SHR0410 monotherapy
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| Assessment of PK parameter-peak time (Tmax) |
| Pre-dose to Day 6 |
| Assessment of PK parameter-peak concentration (Cmax) | Pre-dose to Day 6 |
| Assessment of PK parameter-half-life (t1/2) | Pre-dose to Day 6 |
| Assessment of PK parameter-pparent clearance rate (CL) | Pre-dose to Day 6 |
| Assessment of PK parameter-apparent distribution volume (Vz) | Pre-dose to Day 6 |
| Pharmacokinetic-The ratio of AUC0-t after the first and last administration. | Pre-dose to Day 6 |
| The renal clearance rate of SHR0410 in urine after each administration. | Pre-dose to Day 6 |
| The cumulative excretion rate of SHR0410 in urine after each administration. | Pre-dose to Day 6 |
| D013568 | Pathological Conditions, Signs and Symptoms |