A Randomized, Double-blind, Placebo-controlled Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Study of Administrating Single Ascending Dose of HMS5552 in Healthy Adult Volunteers

Hua Medicine Limited1 个研究点分布在 1 个国家目标入组 60 人开始时间: 2013年9月最近更新: 2017年11月20日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方
入组人数: 60
试验地点: 1
主要终点: Safety and tolerability of HMS5552 will be assessed by adverse event monitoring, physical examinations, 12 lead ECGs, vital sign, and safety laboratory measurements.

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The objectives of this study is to determine the safety profiles, tolerability, pharmacokinetics and pharmacodynamics of HMS5552 following single ascending doses in healthy adult subjects.

详细描述

This will be a randomized, double-blind and placebo-controlled safety study with single oral doses of HMS5552 given to healthy volunteers.

The primary objective is to characterize the safety profiles of HMS5552 following single ascending doses (SAD) in healthy adult subjects.

The secondary objectives include:

To assess the pharmacokinetic profiles of HMS5552 after single dosing
To assess the preliminary pharmacodynamic profiles of HMS5552

Each study subject will receive a single oral dose of HMS5552. During each dosing, eight subjects will be allocated to receive HMS5552 and two subjects will be allocated to receive placebo treatment.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Double (Participant, Investigator)

入排标准

年龄范围: 18 Years 至 45 Years（Adult）
性别: All
接受健康志愿者: 是

入选标准

•Female and male volunteers, 18 to 45 years of age
•BMI: 18 to 24 kg/m2
•Fasting plasma glucose: 3.9 to 6.1 mmol/L
•Glucose level at 2 hours following oral glucose tolerance test <7.8 mmol/L
•HbA1c: 4 to 6.5%
•Normal supine blood pressure and normal ECG recordings

排除标准

•Female with child-bearing potential
•Evidence of clinically-significant renal, cardiac, bronchopulmonary, vascular, gastrointestinal, allergic, neurologic, metabolic (diabetes, thyroid disorders, adrenal disease), immunodeficiency disorders, cancer, hepatitis or cirrhosis.
•Intake of grapefruit or anything that may affect liver enzyme function within 1 month prior to the dosing day
•Clinically-relevant deviation from normal in the physical examination
•Subjects with a medical disorder, condition or history of such that would impair the subject's ability to participate or complete this study in the opinion of the investigator