NCT03500627已完成1 期
A Phase 1 Open-Label Single-Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of OP-101 (Dendrimer N-Acetyl-Cysteine) After Intravenous Administration in Healthy Volunteers
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
- 8
- 试验地点
- 1
- 主要终点
- Number of Participants with Treatment Emergent Adverse Events Graded as Assessed by CTCAE Version 4.0
研究概览
简要总结
A clinical study to measure the effect of OP-101 after being administered intravenously in healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
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
- •Body Mass Index (BMI) between 18 and 32 kg/m^
- •Is in general good health, based upon the results of a medical history assessment, physical examination, vital signs, laboratory profile, and 12-lead electrocardiogram (ECG), as judged by the investigator.
- •Female subjects may not be pregnant, lactating, or breastfeeding.
- •Subjects must have a negative urine test for drugs of abuse, cotinine, and breath alcohol test at screening and Check-in.
排除标准
- •Evidence of clinically significant hematologic, renal, endocrine, pulmonary, cardiac, gastrointestinal, hepatic, psychiatric, neurologic, immunologic, allergic disease, or any other condition that, in the opinion of the Investigator, might significantly interfere with the absorption, distribution, metabolism, or excretion of study drug, or place the subject at an unacceptable risk as a participant in this study.
- •History of malignancy (other than successfully treated basal cell or squamous cell skin cancer).
- •History or presence of an abnormal ECG that, in the opinion of the Investigator, is clinically significant.
- •Has used any product containing nicotine within 90 days prior to screening or intends to use any product containing nicotine during the course of the study.
- •Has used medications that affect gastrointestinal motility or gastric emptying; such as metoclopramide, proton pump inhibitors, and H2 blockers; within 30 days prior to Day
- •Has used prescription or over-the-counter medication, vitamins/herbal supplements (with the exception of hormonal contraceptives) within 14 days prior to Day 1.
研究组 & 干预措施
Cohort 1
Experimental
20 mg/kg OP-101 administered intravenously for over 1 hour.
干预措施: OP-101 (Drug)
Cohort 2
Experimental
40 mg/kg OP-101 administered intravenously for over 1 hour.
干预措施: OP-101 (Drug)
Cohort 3 (optional)
Experimental
80 mg/kg OP-101 administered intravenously for over 1 hour.
干预措施: OP-101 (Drug)
结局指标
主要结局
Number of Participants with Treatment Emergent Adverse Events Graded as Assessed by CTCAE Version 4.0
时间窗: Screening to Day 15.
Evaluate the safety and tolerability of OP-101 after single IV doses in healthy subjects by monitoring and documenting all adverse events, which include laboratory test variables.
次要结局
- Pharmacokinetic (PK) Profile Analysis(Days 1, 2, 3, 4, 8, and 15.)
研究者
研究点 (1)
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