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

Overview

The purpose of this First-in-Human study is to evaluate the safety , tolerability and pharmacokinetics after single ascending of HNC042 given to healthy subjects, compared to placebo. Also, the safety , tolerability and pharmacokinetics of multiple ascending of HNC042 given to healthy subjects daily for 7 days compared to placebo , will be evaluated.

Full Title of Study: “A Randomized, Double-blind, Placebo-controlled, Sequential Parallel Group, Single and Multiple Ascending Doses (SAD/MAD) Study Following Intravenous Administration in Healthy Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetics of HNC042.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: July 19, 2019

Interventions

  • Drug: HNC042 single dose
    • HNC042,freeze-dried powder,single ascending doses Single dose, Intravenous route,starting dose of 100mg escalating up to 1200mg
  • Drug: Placebo single dose
    • Placebo single ascending doses , Intravenous route Single dose, matching placebo
  • Drug: HNC042 multiple ascending doses
    • HNC042,freeze-dried powder,multiple ascending doses, Intravenous route Multiple doses, daily for 7 days, anticipated doses: 300mg to 1200mg
  • Drug: Placebo multiple ascending doses
    • Placebo, multiple ascending doses, Intravenous route, Multiple doses, daily for 7 days, matching placebo

Arms, Groups and Cohorts

  • Experimental: HNC042 single dose
    • HNC042,freeze-dried powder,single ascending doses Single dose,
  • Placebo Comparator: Placebo single dose
    • Placebo single ascending doses , Intravenous route Single dose
  • Experimental: HNC042 multiple ascending doses
    • HNC042,freeze-dried powder,multiple ascending doses, Intravenous route
  • Placebo Comparator: Placebo, multiple ascending doses
    • Placebo, multiple ascending doses, Intravenous route,

Clinical Trial Outcome Measures

Primary Measures

  • Number of subjects with adverse events
    • Time Frame: Between screening and 7 days after the last dose
    • To evaluate the safety and tolerability of HNC042 in comparison with placebo after a single and multiple intravenous dose in healthy subjects in terms of adverse events
  • Number of subjects with abnormal laboratory
    • Time Frame: Between screening and 7days after the last dose
    • To evaluate the safety and tolerability of HNC042 in comparison with placebo after single and multiple intravenous dose in healthy subjects in terms of abnormal laboratory
  • Number of subjects with abnormal electrocardiogram
    • Time Frame: Between screening and 7 days after the last dose
    • To evaluate the safety and tolerability of HNC042 in comparison with placebo after a single and multiple intravenous dose in healthy subjects in terms of abnormal electrocardiogram
  • Number of subjects with abnormal physical examination
    • Time Frame: Between screening and 7 days after the last dose
    • To evaluate the safety and tolerability of HNC042 in comparison with placebo after a single and multiple intravenous dose in healthy subjects in terms of abnormal physical examination
  • Number of subjects with abnormal vital signs
    • Time Frame: Between screening and 7 days after the last dose
    • To evaluate the safety and tolerability of HNC042 in comparison with placebo after a single and multiple intravenous dose in healthy subjects in terms of abnormal vital signs

Secondary Measures

  • The amount of HNC042 in plasma
    • Time Frame: Between Day 1 predose and 24 hours after the (last) dose
    • To characterize the amount of HNC042 in plasma over time – pharmacokinetics (PK) – after a single and multiple intravenous dose in healthy subjects
  • The amount of HNC042 in urine
    • Time Frame: Between Day 1 predose and 24 hours after the (last) dose
    • To characterize the amount of HNC042 in urine over time – pharmacokinetics (PK) – after a single and multiple intravenous dose in healthy subjects

Participating in This Clinical Trial

Inclusion Criteria

  • Healthy volunteer, age 18-56 years
  • BMI between 18-34 kg/m2,and body weight not less than 50.0kg.

Exclusion Criteria

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Guangzhou Henovcom Bioscience Co. Ltd.
  • Provider of Information About this Clinical Study
    • Sponsor

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