Skip to main content
OpenTrials
Completed

NCT Number: NCT03740555

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Paolo B. DePetrillo

Baltimore, Maryland, 21201, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HNC042 single dose

Drug

HNC042,freeze-dried powder,single ascending doses Single dose, Intravenous route,starting dose of 100mg escalating up to 1200mg

Placebo single dose

Drug

Placebo single ascending doses , Intravenous route Single dose, matching placebo

HNC042 multiple ascending doses

Drug

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

Placebo multiple ascending doses

Drug

Placebo, multiple ascending doses, Intravenous route, Multiple doses, daily for 7 days, matching placebo

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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 outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Guangzhou Henovcom Bioscience Co. Ltd.

Industry

Registry information

Official study title

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.

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 14, 2018
Registry last updated
Sep 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.