A Randomised, Double-blind, Single-centre, Placebo-controlled, Dose Escalation, Multiple s.c. DoseStudy to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HS-20004 in Healthy Chinese Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 主要终点
- Number of treatment emergent adverse events (TEAEs)
研究概览
简要总结
This trial is conducted in China. The aim of this trial is to assess the safety and tolerability for Multiple s.c injection of HS-20004 in healthy Chinese subjects
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Body Mass Index (BMI) between 19 and 28 kg/m^2, inclusive, and a total body weight of at least 50 kg;
排除标准
- •Clinically relevant abnormalities of physical examination, laboratory values, vital signs or ECG findings at the screening, as judged by the Investigator;
- •Have any other medical abnormality (such as cardiovascular, hepatic, renal, gastrointestinal, immunologic, hematological, hormonal, metabolic, neoplasmatic or mental disease), which in the opinion of the investigator, might affect the absorption, distribution, metabolism, and excretion of the study drug, or prevent the patient from following and completing the protocol;
- •Family history of diabetes, thyroid cancer, submandibular gland cancer, or history of pancreatitis, cholelithiasis, drug allergy, serious unconscious hypoglycemia or positive of anxious chronic viral hepatitis B, HIV antibody;
- •History of drug or alcohol abuse within 6 months before randomization;
- •Use of GLP-1 analogues, DPP-IV enzyme inhibitors, as well as other hypoglycemic drugs within 3 months before randomization;
- •Use of any prescription drugs and Chinese herbal medicines within 4 weeks before randomization;
- •Use of non prescription drugs and food supplements (vitamins, etc.) within 2 weeks before randomization;
- •Participated any drug clinical trials within 3 months, or participated 3 or more than 3 drug clinical trials within 1 year, or had blood donation/loss >400mL within 3 months before randomization;
- •Female subject of childbearing potential who does not use an acceptable method of birth control, is pregnant or planning a pregnancy, or breastfeeding, or male subject who does not use an acceptable method of birth control, within six months before randomization;
- •Subject who cannot refrain from smoking, eating and/or drinking containing xanthine/caffeine, or strenuous exercise, or others that affect drug absorption, distribution, metabolism and excretion within 2 days before the study drug administration; Subject who is unsuitable for inclusion in the study in the opinion of the investigator;
研究组 & 干预措施
Experimental 1
Once daily subcutaneous dose for 7 Days of HS-20004 0.02 mg or Matched Placebo.
干预措施: HS-20004 (Drug)
Experimental 2
Once daily subcutaneous dose for 7 Days of HS-20004 0.04 mg or Matched Placebo.
干预措施: Placebo (Drug)
Experimental 1
Once daily subcutaneous dose for 7 Days of HS-20004 0.02 mg or Matched Placebo.
干预措施: Placebo (Drug)
Experimental 2
Once daily subcutaneous dose for 7 Days of HS-20004 0.04 mg or Matched Placebo.
干预措施: HS-20004 (Drug)
Experimental 3
Once daily subcutaneous dose for 7 Days of HS-20004 0.06 mg or Matched Placebo.
干预措施: HS-20004 (Drug)
Experimental 3
Once daily subcutaneous dose for 7 Days of HS-20004 0.06 mg or Matched Placebo.
干预措施: Placebo (Drug)
Experimental 4
Once daily subcutaneous dose for 7 Days of HS-20004 0.08 mg or Matched Placebo.
干预措施: HS-20004 (Drug)
Experimental 4
Once daily subcutaneous dose for 7 Days of HS-20004 0.08 mg or Matched Placebo.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of treatment emergent adverse events (TEAEs)
时间窗: Day 0 and up to 3 days after last treatment (Day 10)
次要结局
- Area under the plasma HS-20004 concentration curve after the last s.c injection(Time 0 to 72 hours after the last dose)
- Peak plasma concentration (Cmax) after the last dose(Time 0 to 72 hours after the last treatment)
- Terminal elimination half-life (t½) for HS-20004 after the last dose(Time 0 to 72 hours after the last treatment)
- Change in 24-hour profiles of plasma glucose and serum insulin from baseline(From time 0 to 24 hours after the first and last treatment)