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

NCT04504448 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2022-08-26

No results posted yet for this study

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

Interventions

DRUG

HNC664 capsules Single dose

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

DRUG

HNC664 placebos Single dose

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

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）

Sponsors & Collaborators

  • Guangzhou Henovcom Bioscience Co. Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-08-11
Primary Completion
2021-07-13
Completion
2021-07-13
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04504448 on ClinicalTrials.gov