A Study of HNC042 in Healthy Chinese Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetics

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Double-blind, Placebo-controlled, Sequential Parallel Group, Multiple Ascending Doses Study Following Intravenous Administration in Healthy Chinese Volunteers to Evaluate the Safety, Tolerability, and Pharmacokinetics of HNC042

Conditions
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Influenza

Intervention / Treatment
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* Drug: HNC042 for Injection
* Drug: Placebo Comparator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: volunteers can communicate well with the investigator, understand and comply with the relevant requirements of the study, understand and sign the informed consent Healthy adult male or female volunteers, age 18-65 years， BMI between 19-26 kg/m2,and male body weight not less than 50.0kg,female body weight not less than 45.0kg . volunteers with normal renal function Exclusion Criteria: Any condition that might interfere with the procedures or tests in this study Drug or alcohol abuse Smoking

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HNC042<br>HNC4042 for injection,freeze-dried powder,multiple ascending doses, Intravenous route | Drug: HNC042 for Injection<br>* HNC042,freeze-dried powder,multiple ascending doses, Intravenous route Multiple doses, daily for 7 days, doses: 300mg to 1200mg<br>|
| Placebo Comparator: Placebo<br>Placebo, multiple ascending doses, Intravenous route | Drug: Placebo Comparator<br>* Placebo , Intravenous route , multiple ascending doses<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neuraminidase inhibitor