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

Guangzhou Henovcom Bioscience Co. Ltd.45 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Healthy

Interventions

HNC664 capsules Single doseDRUG

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

HNC664 placebos Single doseDRUG

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

HNC664 capsules FEDDRUG

HNC664 capsules,single doses Single dose, PO,food effect（dosage will be based on data from SAD cohorts and decided by the IDRC）

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Pharmaron

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

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.