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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04504448

Enrollment

Registered

2020-08-07

Start date

2020-08-11

Completion date

2021-07-13

Last updated

2022-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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.

Interventions

DRUGHNC664 capsules Single dose

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

DRUGHNC664 placebos Single dose

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

DRUGHNC664 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）

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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.
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 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 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026