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The study is being conducted to evaluate the tolerability, pharmacokinetics and pharmacodynamics of SHR6508 for Chinese patients with secondary hyperparathyroidism of chronic kidney disease treated by maintenance hemodialysis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group A | Experimental | Experimental: SHR6508 Placebo Comparator: normal saline |
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| group B | Experimental | Experimental: SHR6508 Placebo Comparator: normal saline |
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| group C | Experimental | Experimental: SHR6508 Placebo Comparator: normal saline |
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| group D | Experimental | Experimental: SHR6508 Placebo Comparator: normal saline |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR6508;Placebo | Drug | Group A:SHR6508 low dose |
| |
| SHR6508;Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Tmax, Time of maximum observed concentration. | 0 hour to 43 hours after first dose administration | |
| Cmax, Maximum observed concentration. | 0 hour to 43 hours after first dose administration | |
| AUC0-t, Area under the concentration-time curve from time zero to the last measurable concentration. | 0 hour to 43 hours after first dose administration | |
| AUC0-∞, Area under the curve from time 0 extrapolated to infinite time | 0 hour to 43 hours after first dose administration | |
| t1/2z, Terminal elimination half-life | 0 hour to 43 hours after first dose administration | |
| CLz, Total Body Clearance | 0 hour to 43 hours after first dose administration | |
| Vz, Volume of distribution based on the terminal phase | 0 hour to 43 hours after first dose administration | |
| MRT0-t, Mean residence time from time zero to the last measurable concentration. | 0 hour to 43 hours after first dose administration | |
| MRT0-∞, Mean residence time from time 0 extrapolated to infinite time | 0 hour to 43 hours after first dose administration | |
| Cmax,ss : Maximum observed concentration at steady-state. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in serum iPTH, cCa, P, FGF23 and BSAP | iPTH, FGF23 and BSAP were tested at a central laboratory. | 0 hour to 43 hours after first dose administration |
| Change From Baseline to End of Study in serum iPTH, cCa, P, FGF23 and BSAP |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong Provincial People's Hospital | Guangzhou | Guangdong | China |
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| ID | Term |
|---|---|
| D006962 | Hyperparathyroidism, Secondary |
| ID | Term |
|---|---|
| D006961 | Hyperparathyroidism |
| D010279 | Parathyroid Diseases |
| D004700 | Endocrine System Diseases |
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SHR6508 compared with placebo
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| Drug |
Group B:SHR6508 medium dose |
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| SHR6508;Placebo | Drug | Group C:SHR6508 high dose |
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| SHR6508;Placebo | Drug | Group D:SHR6508 high dose(single dose) |
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| Day1-Day29(if reach steady-state) |
| Cmin,ss : Minimum observed concentration at steady-state | Day1-Day29(if reach steady-state) |
| Cav : Average concentration | Day1-Day29(if reach steady-state) |
| AUC0-t,ss, Area under the concentration-time curve from time zero to the last measurable concentration at steady-state. | Day1-Day29(if reach steady-state) |
| AUC0-∞,ss, Area under the concentration-time curve from time 0 extrapolated to infinite time at steady-state. | Day1-Day29(if reach steady-state) |
| Tmax,ss, Time of maximum observed concentration at steady-state. | Day1-Day29(if reach steady-state) |
| t1/2z,ss, Terminal elimination half-life at steady-state | Day1-Day29(if reach steady-state) |
| CLss, Total Body Clearance at steady-state. | Day1-Day29(if reach steady-state) |
| Vss, Volume of distribution based on the terminal phase at steady-state. | Day1-Day29(if reach steady-state) |
| MRT0-∞, Mean residence time from time 0 extrapolated to infinite time. | Day1-Day29(if reach steady-state) |
| DF: Degree of Fluctuation | Day1-Day29(if reach steady-state) |
| Accumulation Ratio | Day1-Day29(if reach steady-state) |
iPTH, FGF23 and BSAP were tested at a central laboratory.
| Day1 to Day29 |
| Proportion of Participants to End of Study whose iPTH decreased by≥30% from baseline | iPTH was tested at a central laboratory. | Day1 to Day29 |
| Proportion of Participants to End of Study whose iPTH decreased to 300 pg/mL from baseline | iPTH was tested at a central laboratory | Day1 to Day29 |
| Participants With Treatment-Emergent Adverse Events (TEAEs) | Terms were coded with Medical Dictionary for Regulatory Activities (MedDRA) | Day1 to End of Study, End of Study is about Day55 |