NCT02341508已完成1 期
A Phase 1a, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Lpathomab Administered Intravenously to Healthy Volunteers
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Lpath, Inc.
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Proportion of patients with local or systemic Adverse Events
研究概览
简要总结
The primary purpose of this study is to evaluate the safety and tolerability of Lpathomab in healthy volunteers. Additional endpoints include characterization of the pharmacokinetic (PK), pharmacodynamic (PD), and immunogenicity profiles of a single IV dose of Lpathomab in healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female subject ≥ 18 years old between 50 and 145 kg
- •Laboratory values and ECG during Screening period within normal range or evaluated as not clinically significant (NCS)
- •Female subjects must be not of child-bearing potential or using double-barrier method of contraception
- •Male subjects must use double-barrier contraception during the study period
- •Subject is able to read, understand, and sign the informed consent form (ICF) and HIPAA release
排除标准
- •Subjects with diabetes mellitus (glycated hemoglobin [HbA1c]≥6.5%) or pre-diabetes mellitus (HbA1c between 5.7 and 6.4%).
- •Male subjects with corrected Q-T interval (QTc)> 450 msec or a QRS interval>120 msec and female subjects with QTc> 470 or a QRS interval>120 msec.
- •Subject's blood pressure (BP) during screening period exceeds 140/90 mm Hg
- •Subject is positive for HIV, hep B and/or hep C at screening
- •Subject has significant psychiatric co-morbidity including but not limited to major depression-severe, bipolar disorder or schizophrenia spectrum disorder, history of suicide attempt, or active suicidal ideation in 6 months prior to screen.
- •Subject has any significant or advanced systemic illness, unstable or severe medical condition(s) or end stage disease that could put them at risk during the study, interfere with outcome measures, or affect compliance with the protocol procedures and requirements.
- •Subject has history of cancer stability/remission for less than 5 years, with the exception of non-metastatic basal and/or squamous cell carcinomas of the skin and cervical cancer in situ.
结局指标
主要结局
Proportion of patients with local or systemic Adverse Events
时间窗: 85 days
次要结局
未报告次要终点
研究者
研究点 (2)
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