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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04603989

Enrollment

Registered

2020-10-27

Start date

2020-08-01

Completion date

2020-11-13

Last updated

2023-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza

Keywords

Neuraminidase inhibitor

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.

Interventions

DRUGHNC042 for Injection

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

DRUGPlacebo Comparator

Placebo , Intravenous route , multiple ascending doses

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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 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 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 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

Measure	Time frame	Description
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:Vd	Between Day 1 to 7 days	To characterize the pharmacokinetic parameters：Vd of HNC042 after the the first day administer .
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: 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: 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: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: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:CL	Between Day 1 to 7 days	To characterize the pharmacokinetic parameters：CL of HNC042 after the the first day administer .

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026