NCT04146129已完成1 期
A Randomized, Double-Blind, Placebo-Controlled, Phase 1 Single Ascending Dose Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of CDX-0159 in Healthy Subjects
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
- 32
- 试验地点
- 1
- 主要终点
- Safety as assessed by CTCAE v5.0
研究概览
简要总结
This is a study to determine the safety of CDX-0159 in healthy subjects.
详细描述
CDX-0159 is a humanized monoclonal antibody that binds to a protein called KIT that is expressed on mast cells.
This study will evaluate the safety, pharmacokinetics, and pharmacodynamics of CDX-0159 in healthy subjects.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •An informed consent signed and dated by the subject.
- •Healthy volunteer aged 18-
- •In generally good health and without significant medical conditions based on physical exam, ECG, and laboratory test results.
- •Body mass index (BMI) ≥ 18.5 kg/m2 to ≤ 30 kg/m2
- •No medication other than mild analgesics, vitamins and mineral supplements or, oral contraceptives
- •Both males and females of child bearing potential must agree to use a medically accepted contraceptive regimen during study and up to 150 days afterwards.
- •Not a current smoker (or regular user of any nicotine containing product).
- •Willing to follow all study rules
排除标准
- •Women who are pregnant or nursing
- •History of anaphylaxis, food allergies, or allergies (chronic or seasonal) requiring prescription medication
- •Autoimmune disorders requiring more than topical medication
- •History of asthma requiring the use of inhaled medication within the past 5 years.
- •Vaccination with live vaccines within 4 weeks prior to study drug administration (subjects must agree to avoid vaccination during the study).
- •Positive urine test for alcohol and drugs of abuse.
- •Other Protocol defined inclusion and exclusion criteria could apply.
研究组 & 干预措施
CDX-0159
Experimental
Eligible subjects will receive a single dose of CDX-0159
干预措施: CDX-0159 (Drug)
Normal saline
Placebo Comparator
Subjects assigned to receive placebo will receive a single dose of normal saline
干预措施: Normal saline (Drug)
结局指标
主要结局
Safety as assessed by CTCAE v5.0
时间窗: Day 1 to Day 43.
Safety of single, ascending doses of CDX-0159 as determined by percentage of participants with adverse events as assessed by CTCAE v5.0.
次要结局
未报告次要终点
研究者
研究点 (1)
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