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

Phase 1

Completed

• Conditions: Influenza
• Interventions: Drug: HNC042 for Injection; Drug: Placebo Comparator

• Registration Number: NCT04603989
• Lead Sponsor: Guangzhou Henovcom Bioscience Co. Ltd.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-08
• Study Start: 2020-08-01
• Study First Submitted: 2020-10-13
• Study First Submitted QC: 2020-10-26
• Study First Posted: 2020-10-27
• Primary Completion: 2020-11-13
• Study Completion: 2020-11-13
• Last Update Submitted: 2023-02-21
• Last Update Posted: 2023-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HNC042	HNC042 for Injection	HNC4042 for injection,freeze-dried powder,multiple ascending doses, Intravenous route
Placebo	Placebo Comparator	Placebo, multiple ascending doses, Intravenous route

Primary Outcome Measures

Name	Time	Method
Number of subjects with adverse reactions at injection site	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	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	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	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	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	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	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 Outcome Measures

Name	Time	Method
Pharmacokinetics of HNC042 in plasma: Tmax	Between Day 1 to 7 days	To characterize the pharmacokinetic parameters：Tmax of HNC042 after the the first day administer .
Pharmacokinetics of HNC042 in plasma:MRT	Between Day 1 to 7 days	To characterize the pharmacokinetic parameters： MRT of HNC042 after the the first day administer .
Pharmacokinetics of HNC042 in plasma: AUC0-∞	Between Day 1 to 7 days	To characterize the pharmacokinetic parameters： AUC0-∞ of HNC042 after the the first day administer .
Pharmacokinetics of HNC042 in plasma:CL	Between Day 1 to 7 days	To characterize the pharmacokinetic parameters：CL of HNC042 after the the first day administer .
Pharmacokinetics of HNC042 in plasma: AUC0-last	Between Day 1 to 7 days	To characterize the pharmacokinetic parameters：AUC0-last of HNC042 after the the first day administer .
Pharmacokinetics of HNC042 in plasma: Cmax	Between Day 1 to 7 days	To characterize the pharmacokinetic parameters：Cmax of HNC042 after the the first day administer .
Pharmacokinetics of HNC042 in plasma:t1/2	Between Day 1 to 7 days	To characterize the pharmacokinetic parameters： t1/2 of HNC042 after the the first day administer .
Pharmacokinetics of HNC042 in plasma:Vd	Between Day 1 to 7 days	To characterize the pharmacokinetic parameters：Vd of HNC042 after the the first day administer .

Trial Locations

Locations (1)

Jiang Yuting; 🇨🇳 Guangzhou, Guangdong, China