Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The aim of this study is to evaluate the safety, tolerability and pharmacokinetics of SHR0410 in hemodialysis patients with moderate to severe pruritus
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR0410 low dosage | Experimental |
| |
| SHR0410 medium dosage | Experimental |
| |
| SHR0410 high dosage | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR0410 | Drug | administered intravenously |
|
| Measure | Description | Time Frame |
|---|---|---|
| The incidence and severity of any adverse events that occurred between the first administration and the 48-hour period following the last administration | To evaluate the safety and tolerability of repeated doses of SHR0410 | up to 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Area under drug-time curve | To evaluate pharmacokinetic (PK) of repeated doses of SHR0410 | up to 7 days |
| peak time | To evaluate pharmacokinetic (PK) of repeated doses of SHR0410 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jianjun Zou | Contact | 02168868570 | 02168868570 | zoujianjun@hrglobe.cn |
| Li Yue | Contact | yueli@hrglobe.cn |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The first affiliated hospital of sun yat-sen university | Recruiting | Guangzhou | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D011537 | Pruritus |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | administered intravenously |
|
| up to 7 days |
| peak concentration | To evaluate pharmacokinetic (PK) of repeated doses of SHR0410 | up to 7 days |
| half-life | To evaluate pharmacokinetic (PK) of repeated doses of SHR0410 | up to 7 days |
| apparent clearance rate | To evaluate pharmacokinetic (PK) of repeated doses of SHR0410 | up to 7 days |
| apparent distribution volume | To evaluate pharmacokinetic (PK) of repeated doses of SHR0410 | up to 7 days |
| The ratio of AUC0-t after the first and last administration. | To evaluate pharmacokinetic (PK) of repeated doses of SHR0410 | up to 7 days |
| D013568 | Pathological Conditions, Signs and Symptoms |