A Phase I, Randomized, Double-blind, Placebo-controlled Study of Intravenous SHR0410 to Evaluate Safety and Pharmacokinetics in Hemodialysis Participants.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Incidence of Adverse events in terms of changes in Hematology
研究概览
简要总结
This is a multi-site study to evaluate the safety and pharmacokinetics of repeated doses of IV SHR0410 in participants who are undergoing hemodialysis.
详细描述
This is a multi-site study to evaluate the safety and pharmacokinetics of repeated doses of IV SHR0410 in participants who are undergoing hemodialysis. Twenty-four eligible participants will be enrolled into 3 dose cohorts. SHR0410 will be administered after dialysis session. Safety assessments, PK assessments and efficacy evaluations will be performed.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to understand the study procedures, the risks involved and obtain written informed consent before any study related activity.
- •Male or female between the ages of 18 and 75 years, inclusive.
- •Male subjects with a partner of childbearing potential must be willing to use a condom when sexually active, throughout the study period and for 28 days following last study drug dosing. Female subjects must be post-menopausal for at least 1 year, permanently sterilized (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy) or, if of childbearing potential, must be willing to use a highly effective method of contraception throughout the study period and for 28 days following last study drug dosing.
- •Negative drug screen (including alcohol, amphetamines, cocaine, marijuana, opiates, phencyclidine, barbiturates, benzodiazepines, methadone, methamphetamines, tramadol, and tricyclic antidepressants) at screening and on admission to study site.
排除标准
- •Anticipated to receive a kidney transplant during the study.
- •Known history of allergic reaction to opiates such as hives (Note: side effects related to the use of opioids such as constipation or nausea would not exclude the participants from the study).
- •Within 12 months prior to screening, known or suspected history of drug abuse or dependence according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).
研究组 & 干预措施
SHR0410 group
SHR0410 will be dosed
干预措施: SHR0410 (Drug)
Placebo
Placebo will be dosed
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of Adverse events in terms of changes in Hematology
时间窗: 14 days
Hemoglobin Hematocrit Erythrocytes count Mean cell volume, Mean cell hemoglobin concentration, Leukocytes count, Neutrophils count, Lymphocytes count, Monocytes count, Eosinophils count, Basophils count, Platelets count
Incidence of Adverse events in terms of changes in Urinalysis
时间窗: 14 days
Urobilinogen Dipstick urinalysis, including: pH, Specific gravity, Protein, Blood, Leukocytes, Glucose, Ketones, Bilirubin, Nitrites
Incidence of Adverse events in terms of changes in Biochemistry
时间窗: 14 days
Including Serum creatinine, Urea, Alanine aminotransferase, Aspartate aminotransferase, Gamma glutamyl transferase, Total bilirubin, Total protein, Albumin, Alkaline phosphatase, Serum uric acid, Glucose, Triglycerides, Total cholesterol, High-density lipoprotein cholesterol, Low-density lipoprotein cholesterol
Incidence of Adverse events in terms of changes in 12-lead ECGs
时间窗: 14 days
The 12-lead ECGs must be recorded after the subjects have rested in the supine position for 5 minutes to ensure a stable baseline
次要结局
- Area under the plasma concentration versus time curve (AUC)(Up to 24 hours post dose)
- Time to the peak plasma concentration (Tmax)(Up to 24 hours post dose)
- Peak Plasma Concentration (Cmax)(Up to 24 hours post dose)
- Half-time (T1/2)(Up to 24 hours post dose)