NCT01448304已完成1 期
Study of the Tolerability, Safety, Pharmacokinetics and Pharmacodynamics of Alirocumab SAR236553 (REGN727)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Pain using present pain intensity (PPI) verbal questionnaire
研究概览
简要总结
Primary Objective:
Injection Site Tolerability
Secondary Objective:
- To assess the safety profile of alirocumab SAR236553 (REGN727)
- To assess the pharmacokinetic-pharmacodynamic relationship of alirocumab SAR236553 (REGN727)
详细描述
The total duration of study for each subject is up to 15 weeks including a screening period up to 3 weeks.
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
- Double (Participant, Investigator)
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
- 是
入选标准
- •Serum LDL-C levels>100 mg/dL at screening visit.
- •Male or female subject, between 18 and 65 years inclusive.
- •Body weight between 50.0 and 95.0 kg inclusive if male, between 40.0 kg and 85.0 kg inclusive if female, body mass index (BMI) between 18.0 and 30.0 kg/m² inclusive.
- •Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination).
- •Normal vital signs after 10 minutes resting in supine position.
- •Normal standard 12-lead ECG after 10 minutes resting in supine position.
- •Laboratory parameters within the normal range, unless the Investigator considers an abnormality to be clinically irrelevant for healthy subjects.
- •If female, subject must use a double contraception method, except if she is sterilized for more than 3 months or postmenopausal.
排除标准
- •Subjects indicated for the use of statins according to criteria in National Cholesterol Education Program adult treatment panel III Guidelines, as updated in 2004 (see Appendix C).
- •Initiation of a new diet or major change to a previous diet within 4 weeks prior to Screening (Day -21 to -2). Subjects must be willing to maintain a consistent diet for the duration of the study.
- •Use of a medication or nutraceutical in order to alter serum lipids within 4 weeks prior to screening (Day -21 to -2), including but not limited to statins, ezetimibe, fibrates, niacin, or omega-3 fatty acids, bile acid resins.
- •Fasting serum triglycerides >200 mg/dL measured after an 8 to 12 hour fast.
- •History of a hypersensitivity reaction to doxycycline or similar compound.
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
alirocumab SAR236553 (REGN727) - Dose B
Experimental
A single subcutaneous injection of Dose B
干预措施: alirocumab SAR236553 (REGN727) (Drug)
alirocumab SAR236553 (REGN727) - Dose A
Experimental
A single subcutaneous injection of Dose A
干预措施: alirocumab SAR236553 (REGN727) (Drug)
结局指标
主要结局
Pain using present pain intensity (PPI) verbal questionnaire
时间窗: 6 weeks
Edema at injection site by measuring diameter and qualitative assessment
时间窗: 6 weeks
Erythema at injection site by measuring diameter and qualitative assessment
时间窗: 6 weeks
次要结局
- Assessment of PK parameter - maximum concentration (Cmax)(Up to 12 weeks)
- Assessment of PK parameter - area under curve (AUC)(Up to 12 weeks)
- Assessment of PK parameter - time to maximum concentration (tmax)(Up to 12 weeks)
- Number of participants with Adverse Events(Up to 12 weeks)
- Assessment of PK parameter - cluster of differentiation (CD) biomarker (CD29)(Up to 12 weeks)
- Assessment of PK parameter - terminal elimination half-life (t1/2z)(Up to 12 weeks)
- Pharmacodynamics: Change in LDL-C from baseline(Up to 12 weeks)
研究者
研究点 (1)
Loading locations...
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