NCT03709342已完成2 期
A Pharmacodynamic and Pharmacokinetic Study of CM4620 Injectable Emulsion (CM4620-IE) in Patients With Acute Pancreatitis
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Exploratory: Percentage Change in IL-2 Production Relative to Pre-dose Values
研究概览
简要总结
This open-label study will evaluate the pharmacodynamic and pharmacokinetic profile of CM4620-IE in patients with acute pancreatitis. The first five (5) patients will receive ≤ 2.08 mg/kg of CM4620-IE by continuous IV infusion on Day 1. If necessary, up to an additional 4 patients may be treated at a different dose of CM4620-IE as determined by the obtained PK and PD data. The infusion of CM4620-IE will start within 12 hours from the time the patient or LAR provides informed consent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of acute pancreatitis established by the presence of abdominal pain consistent with acute pancreatitis, and 1 of the following 2 criteria:
- •Serum lipase and/or serum amylase > 3 times the upper limit of normal (ULN);
- •Characteristic findings of acute pancreatitis on abdominal imaging;
- •Adults ≥ 18 years of age;
- •A female patient of child-bearing potential who is sexually active with a male partner must be willing to practice acceptable methods of birth control for 365 days after the last dose of CM4620-IE;
- •A male patient who is sexually active with a female partner of childbearing potential must be willing to practice acceptable methods of birth control for 365 days after the last dose of CM4620-IE and must not donate sperm for 365 days;
- •Willing and able to, or have a legal authorized representative (LAR) who is willing and able to, provide informed consent to participate, and cooperate with all aspects of the protocol.
排除标准
- •Any concurrent clinical condition that a study physician believes could potentially pose an unacceptable health risk to the patient while involved in the study or may limit expected survival to < 6 months;
- •Suspected presence of cholangitis in the judgment of the treating investigator;
- •Any malignancy being treated with chemotherapy or immunotherapy;
- •Any autoimmune disease being treated with immunosuppressive medication or immunotherapy (Section 5.3 for list of prohibited medications);
- •History of:
- •Chronic pancreatitis, pancreatic necrosectomy, or pancreatic enzyme replacement therapy;
- •Biopsy proven cirrhosis, portal hypertension, hepatic failure/hepatic encephalopathy;
- •Known hepatitis B or C, or HIV;
- •History of organ or hematologic transplant;
- •Myocardial infarction, revascularization, cardiovascular accident (CVA) in the 30 days prior to Day 1;
- •Current renal replacement therapy;
- •Current known abuse of cocaine or methamphetamine;
- •Known to be pregnant or are nursing;
- •Participated in another study of an investigational drug or therapeutic medical device in the 30 days prior to Day 1;
- •History of allergy to eggs or known hypersensitivity to any components of CM4620-IE;
- •Prior treatment with CM4620-IE.
研究组 & 干预措施
All Patients
Experimental
干预措施: CM4620-IE (Drug)
结局指标
主要结局
Exploratory: Percentage Change in IL-2 Production Relative to Pre-dose Values
时间窗: Predose to 30 minutes post dose
Outcome assessed the percent change in IL-2 production after the administration of a single dose of CM4620-IE as compared to baseline production, for all patients enrolled. This measurement was to explore if there was a change in IL-2 levels with acute pancreatitis after the administration of a single dose of CM4620-IE.
次要结局
- Pharmacokinetics (Plasma Concentration of CM4620): Day 30(Day 30)
- The Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability](From baseline through 30 days)
- Pharmacokinetics (Plasma Concentration of CM4620): Day 2, 20-hr Post End-of-infusion(Day 2)
- Pharmacokinetics (CMax of CM4620): Day 1, 30 Minutes Post End-of-infusion(Days 1, 2, 5, 10 and 30 or at discharge if earlier than day 30)
- Baseline Levels of IL-6(Baseline)
- Pharmacokinetics (Plasma Concentration of CM4620): Day 10 or Discharge(Day 10, or day of discharge)
- Day 1: 30 Minutes Post-infusion IL-6 Levels(Day 1)
- Day 2: 20-hr Post Infusion IL-6 Levels(Day 2)
- Post-infusion IL-6 Levels at Discharge(Assessed at Discharge, between 2 and 9 days.)
研究者
研究点 (1)
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