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

Guangzhou Henovcom Bioscience Co. Ltd.36 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Influenza

Interventions

HNC042 for InjectionDRUG

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

Placebo ComparatorDRUG

Placebo , Intravenous route , multiple ascending doses

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Jiang Yuting

Guangzhou, Guangdong, China

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: Between screening and 15 days after the last dose

Data from ClinicalTrials.gov

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