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| ID | Type | Description | Link |
|---|---|---|---|
| CTR20202022 | Other Identifier | National Medical Products Administration |
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to assess the safety,Tolerability, and pharmacokinetic of KPCXM18 for injection in healthy subjects
To explore the safety, tolerance and pharmacokinetic of KPCXM18 for injection in healthy subjects by intravenous administration of different doses in single and multiple administration safety, tolerance and pharmacokinetic tests, and to obtain the safe dose range of the test drugs, thus providing dose design basis for phase II clinical trials.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KPCXM18 for injection | Experimental | KPCXM18 ,freeze-dried powder,single and multiple ascending doses, Intravenous route |
|
| Placebo | Placebo Comparator | Placebo, freeze-dried powder,single and multiple ascending doses, Intravenous route |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KPCXM18 | Drug | KPCXM18,blind,freeze-dried powder,ascending doses,Intravenous route |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with abnormal vital signs | To evaluate the safety KPCXM 18 for Injection with placebo after multiple intravenous dose in healthy Chinese subjects in terms of abnormal vital signs | through study completion, an average of 2 week |
| Number of subjects with abnormal laboratory | To evaluate the safety KPCXM 18 for Injection with placebo after multiple intravenous dose in healthy Chinese subjects in terms of abnormal laboratory | through study completion, an average of 2 week |
| Number of subjects with abnormal physical examination | To evaluate the safety KPCXM 18 for Injection with placebo after multiple intravenous dose in healthy Chinese subjects in terms of abnormal physical examination | through study completion, an average of 2 week |
| Number of subjects with abnormal electrocardiogram | To evaluate the safety KPCXM 18 for Injection with placebo after multiple intravenous dose in healthy Chinese subjects in terms of abnormal electrocardiogram | through study completion, an average of 2 week |
| Number of subjects with adverse events | To evaluate the safety KPCXM 18 for Injection with placebo after multiple intravenous dose in healthy Chinese subjects in terms of abnormal adverse events | through study completion, an average of 2 week |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of KPCXM18 in plasma: Cmax | To characterize the pharmacokinetic parameters:Cmax of KPCXM18 after the first day administer | Time Frame: Between Day 1 to 7 days |
| Pharmacokinetics of KPCXM18 in plasma: Tmax |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| duo gao, ph.D | Contact | 0871-68319868 | 3502 | duo.gao@kpc.com.cn |
| Name | Affiliation | Role |
|---|---|---|
| yuhong huang, Prof. | Second Affiliated Hospital of Tianjin University of TCM | Principal Investigator |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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Randomized, blind, dose-incrementing, placebo controlled
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blind
| Placebo | Drug | Placebo,blind,freeze-dried powder,ascending doses,Intravenous route |
|
To characterize the pharmacokinetic parameters:Tmax of KPCXM18 after the first day administer
| Time Frame: Between Day 1 to 7 days |
| Pharmacokinetics of KPCXM18 in plasma: AUC0-∞ | To characterize the pharmacokinetic parameters: AUC0-∞ of KPCXM18 after the first day administer | Time Frame: Between Day 1 to 7 days |
| Pharmacokinetics of KPCXM18 in plasma:t1/2 | To characterize the pharmacokinetic parameters: t1/2 of KPCXM18 after the | Time Frame: Between Day 1 to 7 days |
| Pharmacokinetics of KPCXM18 in plasma: Cmax,ss | To characterize the pharmacokinetic parameters:Cmax,ss of KPCXM18 after the 14th day administer | Time Frame: Between Day 1 to 14 days |
| Pharmacokinetics of KPCXM18 in plasma: AUC0-∞,ss | To characterize the pharmacokinetic parameters:AUC0-∞,ss of KPCXM18 after the 14th day administer | Time Frame: Between Day 1 to 14 days |
| Pharmacokinetics of KPCXM18 in plasma: Tmax,ss | To characterize the pharmacokinetic parameters:Tmax,ss of KPCXM18 after the 14th day administer | Time Frame: Between Day 1 to 14 days |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |