A Randomized, Double-Blind, Placebo-Controlled, Three-Part, Phase 1a Dose Escalation Clinical Trial to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of CDX-622 in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- Safety as assessed by Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Trials. Infusion reactions will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
研究概览
简要总结
This is a study to determine the safety of CDX-622 in healthy participants.
详细描述
CDX-622 is a bispecific antibody that binds to stem cell factor (SCF) and thymic stromal lymphopoietin (TSLP).
This study will evaluate the safety, pharmacokinetics, and Pharmacodynamics of IV single ascending doses (Part 1), IV multiple ascending doses (Part 2), and subcutaneous (SC) single ascending doses (Part 3) of CDX-622 in healthy participants.
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 participant.
- •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 kg/m2 to ≤ 32 kg/m
- •No course of medication, whether prescribed or over the counter, in the 4 weeks before study drug administration.
- •Both males and females of childbearing 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.
- •History of asthma requiring the use of inhaled medication within the past 5 years.
- •Vaccination within 4 weeks prior to study drug administration (subjects must agree to avoid vaccination during the study).
- •Blood donation (excluding plasma donation) of approximately 500 mL within 56 days prior to Screening.
- •Positive urine test for alcohol and drugs of abuse.
- •Additional protocol defined inclusion and exclusion criteria could apply.
研究组 & 干预措施
Normal Saline
Eligible participants will receive doses of Normal Saline by IV or SC
干预措施: Normal Saline (Drug)
CDX-622
Eligible participants will receive doses of CDX-622 by IV or SC
干预措施: CDX-622 (Drug)
结局指标
主要结局
Safety as assessed by Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Trials. Infusion reactions will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
时间窗: Day 1 up to Day 127
To evaluate the safety profile as determined by the incidence of adverse events in single or multiple ascending doses of CDX-622 or placebo comparator in healthy participants.
次要结局
- CDX-622 serum evaluations over time(Day 1 up to Day 127)
- CDX-622 biomarker evaluations over time(Day 1 up to Day 127)
- Measurement of anti-drug antibody development over time(Day 1 up to Day 127)