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Completed

NCT Number: NCT04504448

A Study of HNC664 in Healthy Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetics

The purpose of this First-in-Human study is to evaluate the safety , tolerability，PK and PD after single ascending of HNC664 given to healthy subjects, compared to placebo. Also, food effect will be evaluated.

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Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pharmaron

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 18-65 years
  • BMI between 18-32 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

HNC664 capsules Single dose

Drug

HNC664 capsules,single ascending doses Single dose, PO,starting dose of 40mg escalating up to 500mg

Other names: HNC664 capsules

HNC664 placebos Single dose

Drug

HNC664 placebos single ascending doses,PO,Single dose, matching placebo

Other names: HNC664 placebos

HNC664 capsules FED

Drug

HNC664 capsules,single doses Single dose, PO,food effect（dosage will be based on data from SAD cohorts and decided by the IDRC）

Other names: HNC664 capsules

Primary outcomes

  1. Number of subjects with adverse events and concomitant medications

    Time frame: Between screening and 7-9 days after the last dose

    To evaluate the safety and tolerability of HNC664 in comparison with placebo after a single oral dose in healthy subjects in terms of AEs and CMs.

  2. Number of subjects with vital sign measurements

    Time frame: Between screening and 7-9 days after the last dose

    To evaluate the safety and tolerability of HNC664 in comparison with placebo after a single oral dose in healthy subjects in terms of abnormal vital signs

  3. Number of subjects with clinical laboratory test results

    Time frame: Between screening and 7-9 days after the last dose

    To evaluate the safety and tolerability of HNC664 in comparison with placebo after a single oral dose in healthy subjects in terms of abnormal clinical laboratory test results

  4. Number of subjects with 12-lead ECGs

    Time frame: Between screening and 7-9 days after the last dose

    To evaluate the safety and tolerability of HNC664 in comparison with placebo after a single oral dose in healthy subjects in terms of abnormal 12-lead ECGs

  5. Number of subjects with physical examinations

    Time frame: Between screening and 7-9 days after the last dose

    To evaluate the safety and tolerability of HNC664 in comparison with placebo after a single oral dose in healthy subjects in terms of abnormal physical examinations

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 Ascending Doses (SAD) Study Following Oral Administration in Healthy Subjects to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effect of HNC664

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 7, 2020
Registry last updated
Aug 26, 2022

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.

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