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

NCT04504448 | Completed Phase 1 FDA Drug

• 1 other identifier: HNC664-101
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (3)

HNC664 capsules

EXPERIMENTAL

HNC664 capsules,single ascending doses Single dose

Drug: HNC664 capsules Single dose

HNC664 placebos

PLACEBO COMPARATOR

HNC664 placebos,single ascending doses Single dose

Drug: HNC664 placebos Single dose

HNC664 capsules FED

EXPERIMENTAL

HNC664 capsules,food effect,Single dose

Drug: HNC664 capsules FED

Interventions

HNC664 capsules Single dose DRUG

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

Also known as: HNC664 capsules

HNC664 capsules

HNC664 placebos Single dose DRUG

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

Also known as: HNC664 placebos

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）

Also known as: HNC664 capsules

HNC664 capsules FED

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy volunteer, age 18-65 years
• BMI between 18-32 kg/m2,and body weight not less than 50.0kg.

You may not qualify if:

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

Sponsors & Collaborators

• Guangzhou Henovcom Bioscience Co. Ltd.: lead

Study Sites (1)

Pharmaron

Baltimore, Maryland, 21201, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2020
• First Posted: August 7, 2020
• Study Start: August 11, 2020
• Primary Completion: July 13, 2021
• Study Completion: July 13, 2021
• Last Updated: August 26, 2022

Record last verified: 2022-08

Locations

US (1)