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This study was a randomized, double-blind, single-dose and multi-dose, placebo-controlled phase â… clinical trial. Six dose groups were planned for the SAD part of the study and four dose groups were planned for the MAD part. A total of 88 healthy subjects were included.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SAD dose 1 | Experimental |
| |
| SAD dose 2 | Experimental |
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| SAD dose 3 | Experimental |
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| SAD dose 4 | Experimental |
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| SAD dose 5 | Experimental |
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| SAD dose 6 | Experimental |
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| MAD dose 1 | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-6934 injection | Drug | SHR-6934 injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of subjects with adverse events (AEs) | Baseline up to 113 days after the last dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration-time curve from time zero to the time of last quantifiable analyte concentration (AUC0-t) for SHR-6934 | Baseline up to 113 days after the last dosing | |
| Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC0-∞) for SHR-6934 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital, Chinese Academy of Medical Sciences | Beijing | Beijing Municipality | 100730 | China |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| MAD dose 2 | Experimental |
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| MAD dose 3 | Experimental |
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| MAD dose 4 | Experimental |
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| SHR-6934 placebo | Drug | SHR-6934 placebo |
|
| Baseline up to 113 days after the last dosing |
| Maximum plasma concentration (Cmax) for SHR-6934 | Baseline up to 113 days after the last dosing |
| Time to reach maximum plasma concentration (Tmax) for SHR-6934 | Baseline up to 113 days after the last dosing |
| Terminal half-life (t1/2) for SHR-6934 | Baseline up to 113 days after the last dosing |
| Apparent clearance (CL/F) of SHR-6934 for administration subcutaneously | Baseline up to 113 days after the last dosing |
| Apparent volume of distribution (V/F) of SHR-6934 for administration subcutaneously | Baseline up to 113 days after the last dosing |
| Proportion of anti-drug antibodies (ADA) positive subjects | Baseline up to 113 days after the last dosing |
| Baseline and placebo-adjusted QTcF after SHR-6934 | Baseline up to 15 days after dosing |