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

Guangzhou Henovcom Bioscience

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: HNC664 placebos Single dose; Drug: HNC664 capsules FED; Drug: HNC664 capsules Single dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT04504448

HNC664-101

Details and patient eligibility

About

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.

Enrollment: 45 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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45 participants in 3 patient groups, including a placebo group

HNC664 capsules

Experimental group

Description:

HNC664 capsules,single ascending doses Single dose

Treatment:

Drug: HNC664 capsules Single dose

HNC664 placebos

Placebo Comparator group

Description:

HNC664 placebos,single ascending doses Single dose

Treatment:

Drug: HNC664 placebos Single dose

HNC664 capsules FED

Experimental group

Description:

HNC664 capsules,food effect,Single dose

Treatment:

Drug: HNC664 capsules FED