NCT04317209Unknown1 期
A Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study on Safety, Tolerability and Pharmacokinetics of SHR0410 in Hemodialysis Subjects With Moderate to Severe Pruritus
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- The incidence and severity of any adverse events that occurred between the first administration and the 48-hour period following the last administration
研究概览
简要总结
The aim of this study is to evaluate the safety, tolerability and pharmacokinetics of SHR0410 in hemodialysis patients with moderate to severe pruritus
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females aged 18-65 (inclusive);
- •Weight (> 50 kg);
- •Patients with end-stage renal disease receiving hemodialysis (including hemodialysis and hemofiltration) three times a week for at least 3 months.
- •VAS≥4 at screening
排除标准
- •New York cardiac function classification (NYHA) ≥ level III in the current or previous 6 months;
- •Pruritus caused by other than end-stage renal disease or its complications..
- •History of malignancy
- •Any physical or mental illness or condition, as determined by the study investigator, that may increase the risk of participating the trial, affect the subject's compliance with the protocol, or affect the subject's completion of the trial
- •Positive urine drug screening; Or a history of drug abuse;
- •Urine test positive for nicotine;
- •Alcohol breath test positive;
- •Alanine aminotransferase (ALT), aspartate aminotransferase (AST) or transglutaminase (GGT) was 1.5 times higher than the upper limit of normal value (ULN), or total bilirubin was 1.5 times higher than the upper limit of normal value (ULN);
- •Screening for hepatitis c antibody (HCVAb), syphilis antibody or human immunodeficiency virus (HIV) antibody positive; Or hepatitis B is active;
- •Abnormal electrocardiogram considered inappropriate to participate in this study by the investigator
- •positive for human chorionic gonadotropin (hCG) blood test
- •A history of allergies to opioids
- •Has used opioids within one week prior to the current visit, or cannot avoid to use opioids other than the study drug during the study period;
- •Change the treatment regimen for pruritus within 14 days, or cannot avoid to change the treatment regimen for pruritus during the study period
- •Received Ultraviolet phototherapy within 14 days before screening visit; Or cannot avoid to receive ultraviolet light therapy during the study.
- •Change the treatment regimen of gabapentin, pregabalin, or duloxetine within 14 days before screening visit; Or the treatment regimen of gabapentin, pregabalin, or duloxetine cannot be avoided to be changed during the study period.
- •Change the treatment regimen of medications within 14 days that may affect the judgment of antipruritic effect; Or the treatment regimen cannot be avoided to be changed during the study
- •Using topical antipruritic drugs, such as creams and patches with moisturizing or antipruritic effects at present.
- •Kidney transplantation is expected during the study period;
- •Subjects who had Participated in this trial (defined by signing the informed consent);
- •Subjects who had Participated in clinical trials of any other drugs within the previous 3 months; Or plan to participate in other drug trials during the trial period;
- •Subjects who had Participated in the clinical trial of any medical device within the previous 3 months; Or participate in other medical device tests during the trial period.
研究组 & 干预措施
SHR0410 low dosage
Experimental
干预措施: SHR0410 (Drug)
SHR0410 medium dosage
Experimental
干预措施: SHR0410 (Drug)
SHR0410 high dosage
Experimental
干预措施: SHR0410 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
The incidence and severity of any adverse events that occurred between the first administration and the 48-hour period following the last administration
时间窗: up to 7 days
To evaluate the safety and tolerability of repeated doses of SHR0410
次要结局
- Area under drug-time curve(up to 7 days)
- peak concentration(up to 7 days)
- peak time(up to 7 days)
- half-life(up to 7 days)
- apparent clearance rate(up to 7 days)
- apparent distribution volume(up to 7 days)
- The ratio of AUC0-t after the first and last administration.(up to 7 days)
研究者
研究点 (1)
Loading locations...
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