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This study was a single center, parallel, randomized, double blind, placebo-controlled phase Ib clinical trial to to evaluate the safety and tolerability and pharmacokinetics of SPH3127 tablet in healthy subjects by increasing multiple dosing
Three panels(100mg, 200mg, 400mg), each consisting of eight participants (The number of individual subjects in each group was not less than 1/3 of the total number).Participants begin to receive the first dose of SPH3127 100mg. Then Participants begin to receive the second dose of SPH3127 200mg,after the researchers confirmed that the 100mg dose group was safe and well tolerated.Then the third dose of SPH3127 400mg must wait for the result of the second dose's safety and tolerability. If the subjects during escalating dose to the biggest tolerate dose group were not well tolerated, the study must adjust the maximum dose group and fall to a low dose group to conduct another test.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SPH3127 100mg | Experimental | A single dose of SPH3127 50 mg*2 qd *7 days |
|
| Placebo to SPH3127 100mg | Placebo Comparator | A single dose of placebo matching to SPH3127 50mg*2 qd *7 days |
|
| SPH3127 200mg | Experimental | A single dose of SPH3127 100 mg*2 qd *7 days |
|
| Placebo to SPH3127 200mg | Placebo Comparator | A single dose of placebo matching to SPH3127 100mg*2 qd *7 days |
|
| SPH3127 400mg | Experimental | A single dose of SPH3127 100 mg*4 qd *7 days |
|
| Placebo to SPH3127 400mg | Placebo Comparator | A single dose of placebo matching to SPH3127 100mg*4 qd *7 days |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPH3127 50mg | Drug | SPH3127 50mg |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events (AEs) | to assess incidence and intensity of Adverse Events according to Common Toxicity Criteria (CTC version 4.03) associated with increasing doses of SPH3127 | Baseline to 13-16 days post last dose |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma area under curve (AUC)(0-∞) of SPH3127 | to evaluate Plasma AUC(0-∞) of SPH3127 | 10 minutes predose, 0.17hour, 0.33hour, 0.5hour, 0.75hour, 1hour, 1.25hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour postdose at Day 1 and 7; 10 minutes predose at Day 2; 10 minutes predose, 1hour postdose at Day 5 or 6 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The capital medical university affiliated Beijing anzhen hospital | Beijing | Beijing Municipality | 100029 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33653620 | Derived | Jing S, Xu R, Yang K, Liu W, Zhang L, Ke Y, Xia G, Lin Y. Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SPH3127: A Phase I, Randomized, Double-Blind, Placebo-Controlled Trial. Clin Ther. 2021 Apr;43(4):735.e1-735.e14. doi: 10.1016/j.clinthera.2021.01.025. Epub 2021 Feb 27. |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C000709209 | SPH3127 |
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| SPH3127 100mg | Drug | SPH3127 100mg |
|
|
| Placebo matching to SPH3127 50mg | Drug | Placebo matching to SPH3127 50mg |
|
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| Placebo matching to SPH3127 100mg | Drug | Placebo matching to SPH3127 100mg |
|
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| Change from baseline in laboratory hematology values |
to evaluate the Change from baseline in laboratory hematology values |
| Baseline to 13-16 days post last dose |
| Change from baseline in laboratory chemistry values | to evaluate the Change from baseline in laboratory chemistry values | Baseline to 13-16 days post last dose |
| Change from baseline in laboratory urinalysis values | to evaluate the Change from baseline in laboratory urinalysis values | Baseline to 13-16 days post last dose |
| Change from baseline in ECG | to evaluate the Change from baseline in ECG | Baseline to 13-16 days post last dose |
| Maximum Plasma Concentration (Cmax) of SPH3127 | to evaluate Plasma Cmax of SPH3127 | 10 minutes predose, 0.17hour, 0.33hour, 0.5hour, 0.75hour, 1hour, 1.25hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour postdose at Day 1 and 7;10 minutes predose at Day 2; 10 minutes predose, 1hour postdose at Day 5 or 6 |
| Plasma Maximum time to peak (Tmax) of SPH3127 | to evaluate Plasma Tmax of SPH3127 | 10 minutes predose, 0.17hour, 0.33hour, 0.5hour, 0.75hour, 1hour, 1.25hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour postdose at Day 1 and 7;10 minutes predose at Day 2; 10 minutes predose, 1hour postdose at Day 5 or 6 |
| Apparent terminal half-life of SPH3127 | to evaluate terminal half-life of SPH3127 | 10 minutes predose, 0.17hour, 0.33hour, 0.5hour, 0.75hour, 1hour, 1.25hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour postdose at Day 1 and 7;10 minutes predose at Day 2; 10 minutes predose, 1hour postdose at Day 5 or 6 |