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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: HNC664 capsules Single dose; Drug: HNC664 placebos Single dose; Drug: HNC664 capsules FED

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Pharmaron

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / 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; Other Names: HNC664 capsules
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; Other Names: HNC664 placebos
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）; Other Names: HNC664 capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of subjects with adverse events and concomitant medications	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.	Between screening and 7-9 days after the last dose
Number of subjects with vital sign measurements	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	Between screening and 7-9 days after the last dose
Number of subjects with clinical laboratory test results	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	Between screening and 7-9 days after the last dose
Number of subjects with 12-lead ECGs	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	Between screening and 7-9 days after the last dose
Number of subjects with physical examinations	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	Between screening and 7-9 days after the last dose

Collaborators and Investigators

• Sponsor: Guangzhou Henovcom Bioscience Co. Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 11, 2020
• Primary Completion (ACTUAL): July 13, 2021
• Study Completion (ACTUAL): July 13, 2021

Study Registration Dates

• First Submitted: August 5, 2020
• First Submitted That Met QC Criteria: August 6, 2020
• First Posted (ACTUAL): August 7, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 26, 2022
• Last Update Submitted That Met QC Criteria: August 24, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: HNC664-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No