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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: HNC664 capsules Single dose; Drug: HNC664 placebos Single dose; Drug: HNC664 capsules FED

• Registration Number: NCT04504448
• Lead Sponsor: Guangzhou Henovcom Bioscience Co. Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-05
• Study First Submitted QC: 2020-08-06
• Study First Posted: 2020-08-07
• Study Start: 2020-08-11
• Primary Completion: 2021-07-13
• Study Completion: 2021-07-13
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-24
• Last Update Posted: 2022-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HNC664 capsules	HNC664 capsules Single dose	HNC664 capsules,single ascending doses Single dose
HNC664 placebos	HNC664 placebos Single dose	HNC664 placebos,single ascending doses Single dose
HNC664 capsules FED	HNC664 capsules FED	HNC664 capsules,food effect,Single dose

Primary Outcome Measures

Name	Time	Method
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
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
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
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
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.

Trial Locations

Locations (1)

Pharmaron; 🇺🇸 Baltimore, Maryland, United States