NCT04504448

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Guangzhou Henovcom Bioscience Co. Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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）

Timeline

• Start date: 2020-08-11
• Primary completion: 2021-07-13
• Completion: 2021-07-13
• First posted: 2020-08-07
• Last updated: 2022-08-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study