NCT07330778招募中1 期
An Open-Label, Single-Dose Study to Assess the Safety, Pharmacodynamics, and Pharmacokinetics of CDX-622 in Adults With Mild to Moderate Asthma
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 12
- 试验地点
- 4
- 主要终点
- To evaluate the safety and tolerability profile of CDX-622 in adults with mild to moderate asthma.
研究概览
简要总结
This is a study to determine the safety, pharmacodynamics (PD), and pharmacokinetics (PK) of CDX-622 in adults with mild to moderate asthma.
详细描述
CDX-622 is a bispecific antibody that binds to stem cell factor (SCF) and thymic stromal lymphopoietin (TSLP). Eligible participants with mild to moderate asthma will receive a single dose of CDX-622 via IV infusion. Additional follow-up visits will be required through EOS (week 12).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females, ≥ 18 years of age
- •Diagnosis of mild to moderate asthma for at least 12 months
- •Pre-bronchodilator forced expiratory volume in 1 second (FEV1) ≥ 70% of predicted normal
- •Airway reversibility ≥ 12% and 200 mL improvement in FEV1
- •Both males and females of child-bearing potential must agree to use contraception during the study and for 150 days after treatment
- •Willing and able to comply with all study requirements and procedures
排除标准
- •Females who are pregnant or nursing
- •Pulmonary disease other than asthma
- •Systemic diseases with elevated eosinophils other than asthma
- •Hospitalization for treatment of asthma in the past 12 months or required oral corticosteroids due to asthma within the past 6 months
- •History of needing ventilator support due to asthma
- •Current nasal polyps
- •Severe or uncontrolled asthma
- •History of smoking or vaping within the past 6 months
- •Tuberculosis, hepatitis B or C virus, or HIV
- •Immunomodulating biologic therapies within the past 3 months for non-extended half-life biologics.
- •Prior receipt of TSLP or KIT inhibitors such as tezepelumab or briquilimab
- •Additional protocol defined inclusion and exclusion criteria could apply.
研究组 & 干预措施
CDX-622
Experimental
Eligible participants will receive a single dose
干预措施: CDX-622 (Drug)
结局指标
主要结局
To evaluate the safety and tolerability profile of CDX-622 in adults with mild to moderate asthma.
时间窗: Day 1 up to Day 85 (12 weeks)
Occurrence and incidence of Treatment-Emergent Adverse Events (TEAE) and serious adverse events during the study.
次要结局
- Change from baseline in absolute eosinophil count (AEC) through week 12.(Day 1 up to Day 85 (12 weeks))
- Change from baseline in fractional exhaled nitric oxide (FeNO) through week 12.(Day 1 up to Day 85 (12 weeks))
- Change from baseline through week 12 in serum biomarkers.(Day 1 up to Day 85 (12 weeks))
- Pharmacokinetic (PK) evaluation from baseline through week 12.(Day 1 up to Day 85 (12 weeks))
研究者
研究点 (4)
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