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

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

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.

Study Overview

• Status: Completed
• Conditions: Influenza
• Intervention / Treatment: Drug: HNC042 for Injection; Drug: Placebo Comparator

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Jiang Yuting

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HNC042; HNC4042 for injection,freeze-dried powder,multiple ascending doses, Intravenous route	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; Placebo, multiple ascending doses, Intravenous route	Drug: Placebo Comparator; Placebo , Intravenous route , multiple ascending doses

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Guangzhou Henovcom Bioscience Co. Ltd.
• Collaborators: Heilongjiang Zhenbaodao Pharmaceutical Co., Ltd.
• Investigators: Principal Investigator: Lu Xiang, MD, Sir Run Run Hospital, Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2020
• Primary Completion (Actual): November 13, 2020
• Study Completion (Actual): November 13, 2020

Study Registration Dates

• First Submitted: October 13, 2020
• First Submitted That Met QC Criteria: October 26, 2020
• First Posted (Actual): October 27, 2020

Study Record Updates

• Last Update Posted (Estimate): February 23, 2023
• Last Update Submitted That Met QC Criteria: February 21, 2023
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Neuraminidase inhibitor
• Other Study ID Numbers: HNC042-102; ZBD1042-CSP01 (Other Grant/Funding Number: Heilongjiang Zhenbaodao Pharmaceutical Co., Ltd)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No