A Phase 1a, Randomized, Double-Blind, Placebo-Controlled, Single Site, Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of CSX-1004 Injection in Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Treatment-emergent adverse events (AEs), serious AEs, and AEs leading to discontinuation
研究概览
简要总结
This is a Phase 1a, randomized, double-blind, single ascending dose study, designed to assess the safety, tolerability, and PK of a single CSX-1004 injection, administered by IV infusion across a range of doses in healthy adult subjects. The study will have 3 phases: Screening, Inpatient Treatment, and Outpatient Follow-up.
The primary objective of the study is to determine the safety and tolerability of CSX-1004 Injection administered by intravenous (IV) infusion across a range of doses in healthy adult subjects.
The secondary objective of the study is to determine the pharmacokinetics (PK) of CSX-1004 Injection administered by IV infusion across a range of doses in healthy adult subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Major Inclusion Criteria:
- •Healthy male or female subjects, aged 18 to 50 years, inclusive,
- •Minimum weight of 50.0 kg and maximum weight of 100.0 kg
- •Body mass index (BMI) within the range of 18.0 to 32.0 kg/m2, inclusive
排除标准
- •Positive UDS for substances of abuse (including alcohol) at Screening or admission to the Treatment Phase
- •Current daily cigarette smoker within 3 months of Screening. Social smoking, as defined by non-daily use of nicotine-containing products, is permitted.
- •History or presence of any clinically significant cardiac, psychiatric, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, renal, or other major disease or illness at Screening, which in the opinion of the Investigator, might jeopardize the safety of the subject or the validity of the study results.
结局指标
主要结局
Treatment-emergent adverse events (AEs), serious AEs, and AEs leading to discontinuation
时间窗: 5 months
Incidence, intensity, and causality of adverse events
Clinical laboratory assessments
时间窗: 5 months
Hematology, biochemistry, and urinalysis
Vital signs
时间窗: 5 months
Blood pressure and pulse rate
12-Lead electrocardiogram
时间窗: 5 months
Variables will include ventricular heart rate and the PR, QRS, QT, QTcB and QTcF intervals
Physical examination
时间窗: 5 months
Complete physical examination, assessing the subject's overall health and physical condition
Infusion site examination
时间窗: 6 days
Infusion site will be visually inspected for evidence of erythema, edema, itching, pain, infection, bleeding, abnormal healing, and any other abnormalities
次要结局
- Tmax(4 months)
- t1/2(4 months)
- Cmax(4 months)
- AUClast(4 months)
- AUCinf(4 months)