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

Influenza Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04603989
• Other study ID #: HNC042-102
• Secondary ID: ZBD1042-CSP01
• Status: Completed
• Phase: Phase 1
• Start date: August 1, 2020
• Est. completion date: November 13, 2020

Study information

• Verified date: August 2020
• Source: Guangzhou Henovcom Bioscience Co. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: November 13, 2020
• Est. primary completion date: November 13, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Influenza

Intervention

Drug:
• HNC042 for Injection
HNC042,freeze-dried powder,multiple ascending doses, Intravenous route Multiple doses, daily for 7 days, doses: 300mg to 1200mg
• Placebo Comparator
Placebo , Intravenous route , multiple ascending doses

Locations

Country	Name	City	State
China	Jiang Yuting	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Guangzhou Henovcom Bioscience Co. Ltd.	Heilongjiang Zhenbaodao Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	Pharmacokinetics of HNC042 in plasma: AUC0-8	To characterize the pharmacokinetic parameters: AUC0-8 of HNC042 after the the first day administer .	Between Day 1 to 7 days
Secondary	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
Secondary	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
Secondary	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
Secondary	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