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
Overview
- Phase
- Phase 1
- Intervention
- HNC042 for Injection
- Conditions
- Influenza
- Sponsor
- Guangzhou Henovcom Bioscience Co. Ltd.
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Number of subjects with adverse reactions at injection site
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
HNC042
HNC4042 for injection,freeze-dried powder,multiple ascending doses, Intravenous route
Intervention: HNC042 for Injection
Placebo
Placebo, multiple ascending doses, Intravenous route
Intervention: Placebo Comparator
Outcomes
Primary Outcomes
Number of subjects with adverse reactions at injection site
Time Frame: Between screening and 15 days after the last dose
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
Number of subjects with adverse events
Time Frame: Between screening and 15 days after the last dose
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
Number of subjects with abnormal laboratory
Time Frame: Between screening and 15 days after the last dose
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
Number of subjects with abnormal electrocardiogram
Time Frame: Between screening and 15 days after the last dose
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
Number of subjects with abnormal physical examination
Time Frame: Between screening and 15 days after the last dose
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
Number of subjects with abnormal vital signs
Time Frame: Between screening and 15 days after the last dose
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
Number of subjects with clinical symptoms
Time Frame: Between screening and 15 days after the last dose
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
Secondary Outcomes
- Pharmacokinetics of HNC042 in plasma: Tmax(Between Day 1 to 7 days)
- Pharmacokinetics of HNC042 in plasma:MRT(Between Day 1 to 7 days)
- Pharmacokinetics of HNC042 in plasma: AUC0-∞(Between Day 1 to 7 days)
- Pharmacokinetics of HNC042 in plasma:CL(Between Day 1 to 7 days)
- Pharmacokinetics of HNC042 in plasma: AUC0-last(Between Day 1 to 7 days)
- Pharmacokinetics of HNC042 in plasma: Cmax(Between Day 1 to 7 days)
- Pharmacokinetics of HNC042 in plasma:t1/2(Between Day 1 to 7 days)
- Pharmacokinetics of HNC042 in plasma:Vd(Between Day 1 to 7 days)