NCT02999711已完成1 期
A Randomised, Double-blind, Placebo-controlled, Multiple Ascending Dose Study of the Safety, Tolerability, Pharmacokinetic and Pharmacodynamics Effects of Subcutaneously Administered REGN3500 in Adult Patients With Moderate Asthma
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
- 23
- 试验地点
- 1
- 主要终点
- Severity of TEAEs after repeat subcutaneous administration
研究概览
简要总结
Purpose of this study is to assess the safety and tolerability of multiple ascending subcutaneous doses of REGN3500 to moderate asthmatics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body mass index (BMI) of 18 to 32 kg/m2
- •A diagnosis of moderate asthma (according to GINA 2015) for a period of at least 2 years prior to screening.
- •Patient must use a stable medium daily dose level of inhaled corticosteroids (ICS) as defined by GINA guidelines, ie, total daily dose of ICS >400 μg and ≤800 μg/day of budesonide or equivalent for at least 1 month prior to screening and during the study
- •A pre-bronchodilator forced expiratory volume in the first sec (FEV1) ≥60% and ≤90% of the predicted normal values at screening and pre-dose at screening
- •A documented positive response to the reversibility test at the screening, defined as improvement in FEV1 ≥12% and ≥200 mL over baseline after 400 μg salbutamol Pmdi
- •Willing and able to comply with clinic visits and study-related procedures
- •Provide signed informed consent.
排除标准
- •Clinically significant abnormal CBC, clinical chemistry, and urine analysis at screening.
- •Treatment with an investigational drug within 8 weeks or within 5 half-lives (if known), whichever is longer, prior to screening.
- •History of life-threatening asthma
- •Occurrence of asthma exacerbations or respiratory tract infections within 4 weeks prior to screening.
- •Diagnosis of any other airway/pulmonary disease such as Chronic Obstructive Pulmonary Disease (COPD) as defined by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines (GOLD 2016); or other lung diseases (eg, emphysema, idiopathic pulmonary fibrosis, Churg-Strauss syndrome, allergic bronchopulmonary aspergillosis cystic fibrosis, bronchiectasis or alpha-1 antitrypsin deficiency or restrictive lung disease).
- •Chronic or acute infection requiring treatment with systemic antibiotics, antivirals, or antifungals within 1 month prior to screening.
- •Use of oral antibiotics/anti-infectives within 2 weeks prior to screening.
- •Known sensitivity to doxycycline or tetracyclines, or to any of the components of the investigational product formulation.
- •Recent (within the previous 2 months) bacterial, protozoal, viral, or parasite infection.
- •History of tuberculosis or systemic fungal diseases
- •Patients treated with a monoclonal antibody based therapy (such as an anti-IgE, anti-IL-5), a biologic therapy or immunotherapy (subcutaneous immunotherapy [SCIT], sublingual immunotherapy [SLIT], or oral immunotherapy [OIT]) in the previous 12 weeks prior to screening and during the study
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply
研究组 & 干预措施
Cohort 1
Experimental
REGN3500 low dose or placebo
干预措施: REGN3500 (Drug)
Cohort 1
Experimental
REGN3500 low dose or placebo
干预措施: Placebo (Drug)
Cohort 2
Experimental
REGN3500 medium dose or placebo
干预措施: REGN3500 (Drug)
Cohort 2
Experimental
REGN3500 medium dose or placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Severity of TEAEs after repeat subcutaneous administration
时间窗: Up to 36 weeks
Incidence of treatment emergent adverse events (TEAEs) after repeat subcutaneous administration
时间窗: Up to 36 weeks
次要结局
- Percent change in total from baseline forced expiratory volume (FEV) at day 29(Baseline to week 4)
- Change from baseline in biomarkers at day 29(Baseline to week 4)
- Immunogenicity of REGN3500 assessed by measurement of anti-drug antibodies(Up to 36 weeks)
- Percent change from baseline in biomarkers at day 29(Baseline to week 4)
- The concentration-time profile of REGN3500 after repeat subcutaneous administration(Up to 36 weeks)
- Absolute change from baseline fractional exhaled nitric oxide (FeNO) at day 29(Baseline to week 4)
- Percent change of the average of the prior 7 days of FEV1 at day 29 compared to average daily FEV1 during the last 14 days of screening(From -14 days screening to week 4)
- Percent change from baseline FeNO at day 29(Baseline to week 4)
研究者
研究点 (1)
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