Clinical trial NCT04603989: A Study of HNC042 in Healthy Chinese Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetics
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Influenza
Keywords: Neuraminidase inhibitor
Lead sponsor: Guangzhou Henovcom Bioscience Co. Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Heilongjiang Zhenbaodao Pharmaceutical Co., Ltd.
First posted: 2020-10-27
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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
* Smoking

Primary outcomes:
measure: Number of subjects with abnormal vital signs
timeFrame: Between screening and 15 days after the last dose
measure: Number of subjects with abnormal laboratory
timeFrame: Between screening and 15 days after the last dose
measure: Number of subjects with abnormal electrocardiogram
timeFrame: Between screening and 15 days after the last dose
measure: Number of subjects with abnormal physical examination
timeFrame: Between screening and 15 days after the last dose
measure: Number of subjects with adverse reactions at injection site
timeFrame: Between screening and 15 days after the last dose
measure: Number of subjects with adverse events
timeFrame: Between screening and 15 days after the last dose
measure: Number of subjects with clinical symptoms
timeFrame: Between screening and 15 days after the last dose
Secondary outcomes:
measure: Pharmacokinetics of HNC042 in plasma: Cmax
timeFrame: Between Day 1 to 7 days
measure: Pharmacokinetics of HNC042 in plasma: Tmax
timeFrame: Between Day 1 to 7 days
measure: Pharmacokinetics of HNC042 in plasma: AUC0-last
timeFrame: Between Day 1 to 7 days
measure: Pharmacokinetics of HNC042 in plasma: AUC0-∞
timeFrame: Between Day 1 to 7 days
measure: Pharmacokinetics of HNC042 in plasma:t1/2
timeFrame: Between Day 1 to 7 days
measure: Pharmacokinetics of HNC042 in plasma:MRT
timeFrame: Between Day 1 to 7 days
measure: Pharmacokinetics of HNC042 in plasma:CL
timeFrame: Between Day 1 to 7 days
measure: Pharmacokinetics of HNC042 in plasma:Vd
timeFrame: Between Day 1 to 7 days
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Jiang Yuting
state: Guangdong
Study officials:
affiliation: Nanjing Medical University
name: Lu Xiang, MD
role: PRINCIPAL_INVESTIGATOR
References: