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

NCT04603989 | Completed Phase 1 FDA Drug

• 2 other identifiers: HNC042-102ZBD1042-CSP01
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Influenza

Keywords

Neuraminidase inhibitor

Outcome Measures

Primary Outcomes (7)

• 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

  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

  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

  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

  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

  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

  Between screening and 15 days after the last dose

• Number of subjects with clinical symptoms

  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

  Between screening and 15 days after the last dose

Secondary Outcomes (8)

• Pharmacokinetics of HNC042 in plasma: Cmax

  Between Day 1 to 7 days

• Pharmacokinetics of HNC042 in plasma: Tmax

  Between Day 1 to 7 days

• Pharmacokinetics of HNC042 in plasma: AUC0-last

  Between Day 1 to 7 days

• Pharmacokinetics of HNC042 in plasma: AUC0-∞

  Between Day 1 to 7 days

• Pharmacokinetics of HNC042 in plasma:t1/2

  Between Day 1 to 7 days

Study Arms (2)

HNC042

EXPERIMENTAL

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

Drug: HNC042 for Injection

Placebo

PLACEBO COMPARATOR

Placebo, multiple ascending doses, Intravenous route

Drug: Placebo Comparator

Interventions

HNC042 for Injection DRUG

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

HNC042

Placebo Comparator DRUG

Placebo , Intravenous route , multiple ascending doses

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Any condition that might interfere with the procedures or tests in this study
• Drug or alcohol abuse
• Smoking

Sponsors & Collaborators

• Guangzhou Henovcom Bioscience Co. Ltd.: lead
• Heilongjiang Zhenbaodao Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Jiang Yuting

Guangzhou, Guangdong, 510000, China

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

Injections

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Lu Xiang, MD

  Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2020
• First Posted: October 27, 2020
• Study Start: August 1, 2020
• Primary Completion: November 13, 2020
• Study Completion: November 13, 2020
• Last Updated: February 23, 2023

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)