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NCT Number: NCT04603989

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

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.

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Key information

Conditions

Influenza Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Jiang Yuting

Guangzhou, Guangdong, 510000, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HNC042 for Injection

Drug

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

placebo comparator

Drug

Placebo , Intravenous route , multiple ascending doses

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  1. Pharmacokinetics of HNC042 in plasma: Cmax

    Time frame: Between Day 1 to 7 days

    To characterize the pharmacokinetic parameters：Cmax of HNC042 after the the first day administer .

  2. Pharmacokinetics of HNC042 in plasma: Tmax

    Time frame: Between Day 1 to 7 days

    To characterize the pharmacokinetic parameters：Tmax of HNC042 after the the first day administer .

  3. Pharmacokinetics of HNC042 in plasma: AUC0-last

    Time frame: Between Day 1 to 7 days

    To characterize the pharmacokinetic parameters：AUC0-last of HNC042 after the the first day administer .

  4. Pharmacokinetics of HNC042 in plasma: AUC0-∞

    Time frame: Between Day 1 to 7 days

    To characterize the pharmacokinetic parameters： AUC0-∞ of HNC042 after the the first day administer .

  5. Pharmacokinetics of HNC042 in plasma:t1/2

    Time frame: Between Day 1 to 7 days

    To characterize the pharmacokinetic parameters： t1/2 of HNC042 after the the first day administer .

  6. Pharmacokinetics of HNC042 in plasma:MRT

    Time frame: Between Day 1 to 7 days

    To characterize the pharmacokinetic parameters： MRT of HNC042 after the the first day administer .

  7. Pharmacokinetics of HNC042 in plasma:CL

    Time frame: Between Day 1 to 7 days

    To characterize the pharmacokinetic parameters：CL of HNC042 after the the first day administer .

  8. Pharmacokinetics of HNC042 in plasma:Vd

    Time frame: Between Day 1 to 7 days

    To characterize the pharmacokinetic parameters：Vd of HNC042 after the the first day administer .

Sponsors and collaborators

Lead sponsor

Guangzhou Henovcom Bioscience Co. Ltd.

Industry

Collaborators

  • Heilongjiang Zhenbaodao Pharmaceutical Co., Ltd.

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Oct 27, 2020
Registry last updated
Feb 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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