NCT03006237已完成1 期
A Phase 1 Open Label Single Center Safety, Tolerability and Pharmacokinetic Study of IS-001 Injection in Patients Undergoing Robotic Hysterectomy Using the da Vinci® Si/Xi Surgical System With Firefly® Fluorescent Imaging
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Monitor Safety Parameters (vital signs, ECG, serum chemistry and hematology, urinalysis and adverse events)
研究概览
简要总结
A Phase 1 Open Label Single Center Safety, Tolerability and Pharmacokinetic Study of IS-001
详细描述
A Phase 1 Open Label Single Center Safety, Tolerability and Pharmacokinetic Study of IS-001 Injection in Patients Undergoing Robotic Hysterectomy Using the da Vinci® Si/Xi Surgical System with Firefly® Fluorescent Imaging
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Subject is between the ages of 18 and
- •Subject is scheduled to undergo robotic hysterectomy using a da Vinci® Si/Xi surgical system with Firefly® fluorescent imaging.
- •Subject is willing and able to provide informed consent.
- •Subject is considered capable of complying with study procedures.
- •Subject has no medical history of liver or kidney disease.
- •Subject has no evidence of NYHA Class II-IV cardiac disease.
- •Subject has recent (< 3 months) clinical hematology (CBC) values within the acceptable values reference range.
- •Subject has recent (< 3 months) clinical serum chemistry (CMP) values within the acceptable values reference range.
排除标准
- •Subject is pregnant or nursing.
- •Subject has a history of alcoholism.
- •Subject has a history of drug abuse.
- •Subject has known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
- •Subject has known human immunodeficiency virus (HIV) infection.
- •Subject has been diagnosed with or treated for cancer in the last 2 years.
- •Subject has a total body weight < 32 kg.
- •Subject has after 5 minutes of supine rest a diastolic blood pressure ≥100 mmHg and/or a systolic blood pressure ≥160 mmHg.
- •Subject has after 5 minutes of supine rest a resting heart rate ≤35 or ≥115 bpm.
- •Subject has any other condition or personal circumstance that, in the judgment of the investigator, might interfere with the collection of complete good quality data or represents an unacceptable safety liability.
研究组 & 干预措施
IV IS-001 drug
Experimental
IV IS-001 given during hysterectomy performed with da Vinci® Si/Xi Surgical System
干预措施: IS-001 (Drug)
IV IS-001 drug
Experimental
IV IS-001 given during hysterectomy performed with da Vinci® Si/Xi Surgical System
干预措施: da Vinci® Si/Xi Surgical System (Device)
结局指标
主要结局
Monitor Safety Parameters (vital signs, ECG, serum chemistry and hematology, urinalysis and adverse events)
时间窗: 14 days
Vital signs, 12-lead ECG, serum chemistry (CMP) and hematology (CBC), urinalysis and incidence of treatment-emergent adverse events
次要结局
- Evaluation of pharmacokinetic parameter of IS-001: Tmax(6 hours)
- Evaluation of pharmacokinetic parameter of IS-001: t1/2(6 hours)
- Evaluation of pharmacokinetic parameter of IS-001: Cmax(6 hours)
- Evaluation of pharmacokinetic parameter of IS-001: AUC(6 hours)
研究者
研究点 (1)
Loading locations...
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