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

Sponsor
Guangzhou Henovcom Bioscience Co. Ltd. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04504448
Collaborator
(none)
46
Enrollment
1
Location
3
Arms
20.6
Anticipated Duration (Months)
2.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: HNC664 capsules Single dose
  • Drug: HNC664 placebos Single dose
  • Drug: HNC664 capsules FED
 Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
46 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official 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
Actual Study Start Date :
Aug 11, 2020
Actual Primary Completion Date :
Jul 11, 2021
Anticipated Study Completion Date :
Apr 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: HNC664 capsules

HNC664 capsules,single ascending doses Single dose

Drug: HNC664 capsules Single dose
HNC664 capsules,single ascending doses Single dose, PO,starting dose of 40mg escalating up to 500mg
Placebo Comparator: HNC664 placebos

HNC664 placebos,single ascending doses Single dose

Drug: HNC664 placebos Single dose
HNC664 placebos single ascending doses,PO,Single dose, matching placebo
Experimental: HNC664 capsules FED

HNC664 capsules,food effect,Single dose

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

Outcome Measures

Primary Outcome Measures

  1. Number of subjects with adverse events and concomitant medications [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 [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 [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 [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 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Pharmaron Baltimore Maryland United States 21201

Sponsors and Collaborators

  • Guangzhou Henovcom Bioscience Co. Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Guangzhou Henovcom Bioscience Co. Ltd.
ClinicalTrials.gov Identifier:
NCT04504448
Other Study ID Numbers:
  • HNC664-101
First Posted:
Aug 7, 2020
Last Update Posted:
Apr 4, 2022
Last Verified:
Mar 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Apr 4, 2022