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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04504448
• Other study ID #: HNC664-101
• Status: Completed
• Phase: Phase 1
• Start date: August 11, 2020
• Est. completion date: July 13, 2021

Study information

• Verified date: August 2022
• Source: Guangzhou Henovcom Bioscience Co. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: July 13, 2021
• Est. primary completion date: July 13, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• HNC664 capsules Single dose
HNC664 capsules,single ascending doses Single dose, PO,starting dose of 40mg escalating up to 500mg
• HNC664 placebos Single dose
HNC664 placebos single ascending doses,PO,Single dose, matching placebo
• 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)

Locations

Country	Name	City	State
United States	Pharmaron	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou Henovcom Bioscience Co. Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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