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

Guangzhou Henovcom Bioscience

Status and phase: Completed; Phase 1

Conditions: Influenza

Treatments: Drug: HNC042 for Injection; Drug: Placebo Comparator

Study type: Interventional

Funder types: Industry

Identifiers

NCT04603989

ZBD1042-CSP01 (Other Grant/Funding Number)

HNC042-102

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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36 participants in 2 patient groups, including a placebo group

HNC042

Experimental group

Description:

HNC4042 for injection,freeze-dried powder,multiple ascending doses, Intravenous route

Treatment:

Drug: HNC042 for Injection

Placebo

Placebo Comparator group

Description:

Placebo, multiple ascending doses, Intravenous route

Treatment:

Drug: Placebo Comparator