NCT05983289已完成1 期
A Single Center, Randomized, Double-blind, Placebo-controlled Study To Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Single Escalating Doses Of HSK7653 In Healthy Subjects
Haisco Pharmaceutical Group Co., Ltd.1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2018年5月8日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
研究概览
简要总结
To evaluate the safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of single dose of HSK7653 tablets in healthy adult subjects, and to identify the metabolites of HSK7653 in healthy adult subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥18 and Age ≤60 years
- •BMI ≥18 and BMI ≤ 25 kg/m2 (Body Mass Index)
- •Able to understand the procedures of the study, provide written informed consent, and be willing to comply with the protocol of the study
排除标准
- •Any finding of the medical examination (physical examination, laboratory examination, 12-ECG, abdominal B-ultrasonography, etc) deviating from normal and of clinical relevance during screening
- •Evidence or history of clinically significant renal, gastrointestinal (including pancreatitis), hepatic disease at the time of screening
- •Has a positive result on screening for serum hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCVAb), Treponema pallidum antibody (TP-Ab) or human immunodeficiency virus (HIV)
- •Treatment with an investigational drug within 3 months
- •Fertile male subjects who are unwilling or unable to use a highly effective method of contraception for the duration of the study and for at least 6 months after the last dose
研究组 & 干预措施
HSK7653
Experimental
Single dose, oral
干预措施: HSK7653 (Drug)
Placebo
Placebo Comparator
Single dose, oral
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
时间窗: First dose of study drug up to 29 days after last dose of study drug
Assessment by adverse event monitoring, 12 lead ECGs, vital signs and laboratory measurements.
次要结局
- Area Under the Curve From Time Zero to Last Quantifiable Concentration(Pre dose and at 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 72, 168 (day 8), 336 (day 15), 504(day 22), 672 (day 29) hours following single dose administration;)
- Maximum Observed Plasma Concentration (Cmax)(Pre dose and at 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 72, 168 (day 8), 336 (day 15), 504(day 22), 672 (day 29) hours following single dose administration;)
- Time to Reach Maximum Observed Plasma Concentration (Tmax)(Pre dose and at 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 72, 168 (day 8), 336 (day 15), 504(day 22), 672 (day 29) hours following single dose administration;)
- Plasma Decay Half-Life (t1/2)(Pre dose and at 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 72, 168 (day 8), 336 (day 15), 504(day 22), 672 (day 29) hours following single dose administration;)
- Inhibition Rate of Dipeptidyl Peptidase 4 (DPP4) Activities following single dose administration(Pre dose and at 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 72, 168 (day 8), 336 (day 15), 504(day 22), 672 (day 29) hours following single dose administration;)
研究者
研究点 (1)
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