Safety Study of ISIS 325568 in Healthy Volunteers
A Phase I, Double-Blind, Placebo-Controlled, Dose- Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of ISIS 325568 Administered to Healthy Volunteers
研究概览
详细说明
研究类型
注册 (预期的)
阶段
- 阶段1
联系人和位置
学习地点
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-
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Leiden、荷兰
- Centre For Human Drug Research
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Age 18 to 65 years
- Males or females. Females must be non-pregnant and non-lactating, and either surgically sterile (hysterectomy, oophorectomy, or tubal ligation) or post-menopausal. Males must be surgically sterile, abstinent or if engaged in sexual relations of child-bearing potential, subject or partner must be using an acceptable contraceptive method during the trial and for 9 weeks after the last dose of study drug.
- Give written informed consent to participate in study and availability for all study requirements
- Fasting plasma glucose ≤ the upper limit of the laboratory's reference range (ULN)
- HbA1C ≤ ULN
- BMI < 30 kg/m2
Exclusion Criteria:
- Clinically significant abnormalities in medical history or physical examination
- Abnormalities on laboratory examination (ALT > ULN, AST > ULN, bilirubin > ULN, creatinine > ULN, urine protein positive by urine dipstick, platelets < lower limit of normal and any other clinically significant laboratory findings)
- History of clinically significant abnormalities in coagulation parameters
- Positive test result for HIV, hepatitis B virus, and/or hepatitis C virus
- Active infection requiring antiviral or antimicrobial therapy
- Subjects on chronic or acute prescription medication may be permitted after discussion with the Isis Medical Monitor.
- Malignancy (with the exception of basal or squamous cell carcinoma of the skin if adequately treated and no recurrence for > 1 year)
- Any other concurrent condition which, in the opinion of the Investigator, would preclude participation in this study or interfere with compliance
- History of alcohol or drug abuse
- Undergoing or have undergone treatment with another investigational drug, biologic agent or device within 90 days prior to Screening.
- Blood donation within three months of screening
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：A
50 mg ISIS 325568 vs Placebo, s.c.
injection
|
4 arms of single dose s.c. injections: A 50 mg B 100 mg C 200 mg D 400 mg 4 arms of multi-dose: 3 i.v. infusions over 1 week followed by 5 weekly s.c. injections AA 50 mg BB 100 mg CC 200 mg DD 400 mg or EE 50 mg Placebo: 0.9% Sodium Chloride |
|
实验性的：B
100 mg ISIS 325568 vs Placebo , s.c.
injection
|
4 arms of single dose s.c. injections: A 50 mg B 100 mg C 200 mg D 400 mg 4 arms of multi-dose: 3 i.v. infusions over 1 week followed by 5 weekly s.c. injections AA 50 mg BB 100 mg CC 200 mg DD 400 mg or EE 50 mg Placebo: 0.9% Sodium Chloride |
|
实验性的：C
200 mg ISIS 325568 vs Placebo , s.c.
injection
|
4 arms of single dose s.c. injections: A 50 mg B 100 mg C 200 mg D 400 mg 4 arms of multi-dose: 3 i.v. infusions over 1 week followed by 5 weekly s.c. injections AA 50 mg BB 100 mg CC 200 mg DD 400 mg or EE 50 mg Placebo: 0.9% Sodium Chloride |
|
实验性的：D
400 mg ISIS 325568 vs Placebo, s.c.
injection
|
4 arms of single dose s.c. injections: A 50 mg B 100 mg C 200 mg D 400 mg 4 arms of multi-dose: 3 i.v. infusions over 1 week followed by 5 weekly s.c. injections AA 50 mg BB 100 mg CC 200 mg DD 400 mg or EE 50 mg Placebo: 0.9% Sodium Chloride |
|
实验性的：AA
50 mg ISIS 325568, 3x over 1 week i.v.
infusion, weekly s.c.
injection for 5 weeks vs Placebo
|
4 arms of single dose s.c. injections: A 50 mg B 100 mg C 200 mg D 400 mg 4 arms of multi-dose: 3 i.v. infusions over 1 week followed by 5 weekly s.c. injections AA 50 mg BB 100 mg CC 200 mg DD 400 mg or EE 50 mg Placebo: 0.9% Sodium Chloride |
|
实验性的：BB
100 mg ISIS 325568, 3x over 1 week i.v.
infusion, weekly s.c.
injection for 5 weeks vs Placebo
|
4 arms of single dose s.c. injections: A 50 mg B 100 mg C 200 mg D 400 mg 4 arms of multi-dose: 3 i.v. infusions over 1 week followed by 5 weekly s.c. injections AA 50 mg BB 100 mg CC 200 mg DD 400 mg or EE 50 mg Placebo: 0.9% Sodium Chloride |
|
实验性的：CC
200 mg ISIS 325568, 3x over 1 week i.v.
infusion, weekly s.c.
injection for 5 weeks vs Placebo
|
4 arms of single dose s.c. injections: A 50 mg B 100 mg C 200 mg D 400 mg 4 arms of multi-dose: 3 i.v. infusions over 1 week followed by 5 weekly s.c. injections AA 50 mg BB 100 mg CC 200 mg DD 400 mg or EE 50 mg Placebo: 0.9% Sodium Chloride |
|
实验性的：DD
400 mg ISIS 325568, 3x over 1 week i.v.
infusion, weekly s.c.
injection for 5 weeks vs Placebo
|
4 arms of single dose s.c. injections: A 50 mg B 100 mg C 200 mg D 400 mg 4 arms of multi-dose: 3 i.v. infusions over 1 week followed by 5 weekly s.c. injections AA 50 mg BB 100 mg CC 200 mg DD 400 mg or EE 50 mg Placebo: 0.9% Sodium Chloride |
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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safety and tolerability
大体时间：30 days for single dose, 16 weeks for multi-dose
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30 days for single dose, 16 weeks for multi-dose
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
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Pharmacokinetic profile all doses and Pharmacodynamics for multi-dose groups.
大体时间：4 days for single dose, 16 weeks for multi-dose
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4 days for single dose, 16 weeks for multi-dose
|
合作者和调查者
调查人员
- 首席研究员：J. Burggraaf, MD PhD、Centre For Human Drug Research
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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