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| ID | Type | Description | Link |
|---|---|---|---|
| ZBD1042-CSP01 | Other Grant/Funding Number | Heilongjiang Zhenbaodao Pharmaceutical Co., Ltd |
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| Name | Class |
|---|---|
| Heilongjiang Zhenbaodao Pharmaceutical Co., Ltd. | INDUSTRY |
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The purpose of this study is to evaluate the safety , tolerability and pharmacokinetics after multiple ascending of HNC042 given to healthy Chinese volunteers, compared to placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HNC042 | Experimental | HNC4042 for injection,freeze-dried powder,multiple ascending doses, Intravenous route |
|
| Placebo | Placebo Comparator | Placebo, multiple ascending doses, Intravenous route |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HNC042 for Injection | Drug | HNC042,freeze-dried powder,multiple ascending doses, Intravenous route Multiple doses, daily for 7 days, doses: 300mg to 1200mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with abnormal vital signs | To evaluate the safety and tolerability of HNC042 in comparison with placebo after multiple intravenous dose in healthy Chinese subjects in terms of abnormal vital signs | Between screening and 15 days after the last dose |
| Number of subjects with abnormal laboratory | To evaluate the safety and tolerability of HNC042 in comparison with placebo after multiple intravenous dose in healthy Chinese subjects in terms of abnormal laboratory | Between screening and 15 days after the last dose |
| Number of subjects with abnormal electrocardiogram | To evaluate the safety and tolerability of HNC042 in comparison with placebo after multiple intravenous dose in healthy Cjinese subjects in terms of abnormal electrocardiogram | Between screening and 15 days after the last dose |
| Number of subjects with abnormal physical examination | To evaluate the safety and tolerability of HNC042 in comparison with placebo after multiple intravenous dose in healthy Cjinese subjects in terms of abnormal physical examination | Between screening and 15 days after the last dose |
| Number of subjects with adverse reactions at injection site | To evaluate the safety and tolerability of HNC042 in comparison with placebo after multiple intravenous dose in healthy Cjinese subjects in terms of adverse reactions at injection site | Between screening and 15 days after the last dose |
| Number of subjects with adverse events | To evaluate the safety and tolerability of HNC042 in comparison with placebo after multiple intravenous dose in healthy Cjinese subjects in terms of adverse events |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of HNC042 in plasma: Cmax | To characterize the pharmacokinetic parameters：Cmax of HNC042 after the the first day administer . | Between Day 1 to 7 days |
| Pharmacokinetics of HNC042 in plasma: Tmax |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lu Xiang, MD | Nanjing Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jiang Yuting | Guangzhou | Guangdong | 510000 | China |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| Placebo Comparator | Drug | Placebo , Intravenous route , multiple ascending doses |
|
| Between screening and 15 days after the last dose |
| Number of subjects with clinical symptoms | To evaluate the safety and tolerability of HNC042 in comparison with placebo after multiple intravenous dose in healthy Cjinese subjects in terms of clinical symptoms | Between screening and 15 days after the last dose |
To characterize the pharmacokinetic parameters：Tmax of HNC042 after the the first day administer .
| Between Day 1 to 7 days |
| Pharmacokinetics of HNC042 in plasma: AUC0-last | To characterize the pharmacokinetic parameters：AUC0-last of HNC042 after the the first day administer . | Between Day 1 to 7 days |
| Pharmacokinetics of HNC042 in plasma: AUC0-∞ | To characterize the pharmacokinetic parameters： AUC0-∞ of HNC042 after the the first day administer . | Between Day 1 to 7 days |
| Pharmacokinetics of HNC042 in plasma:t1/2 | To characterize the pharmacokinetic parameters： t1/2 of HNC042 after the the first day administer . | Between Day 1 to 7 days |
| Pharmacokinetics of HNC042 in plasma:MRT | To characterize the pharmacokinetic parameters： MRT of HNC042 after the the first day administer . | Between Day 1 to 7 days |
| Pharmacokinetics of HNC042 in plasma:CL | To characterize the pharmacokinetic parameters：CL of HNC042 after the the first day administer . | Between Day 1 to 7 days |
| Pharmacokinetics of HNC042 in plasma:Vd | To characterize the pharmacokinetic parameters：Vd of HNC042 after the the first day administer . | Between Day 1 to 7 days |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |