A Multicenter, Randomized, Double-blind, Placebo-controlled Phase Ib Study to Determine the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Recombinant Anti-IL-5 Humanized Monoclonal Antibody Therapy in Adult Subjects With Severe Eosinophilic Asthma
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Adverse events(AEs)
研究概览
简要总结
This study will assess the safety, tolerability, pharmacokinetics and preliminary efficacy of 610 as an adjunctive therapy in adult subjects with severe eosinophilic asthma.
详细描述
This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of 610 in adults with severe eosinophilic asthma. Plan to recruit 24 subjects, and the subjects divided into 3 groups: 610 30mg group，100mg group, 610 300mg group，8 subjects in each dose group, of which 6 received the trial drug and 2 received placebo. The study is divided into screening period of 2 weeks, treatment period of 32 weeks and follow-up period of 12 weeks.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Diagnosed with asthma for ≥12 months
- •Within 3 months before screening, treatment with medium to high dose inhaled corticosteroid（ICS，inhaled fluticasone at a dosage of at least 500 μg, or equivalent, daily.）and at least one other additional controller medication, such as long-acting β₂ receptor agonist (LABA), leukotriene receptor antagonist (LTRA), theophylline, long-acting Anticholinergic drugs (LAMA), etc. Those medicine must be stable for ≥ 28 days prior to screening and baseline and must continue without dosage changes throughout the study
- •In the past 12 months prior to screening， at least one time asthma exacerbations history
- •Pre-bronchodilator FEV1 <80% predicted value
- •Asthma-related blood eosinophils ≥ 150 cells/μL within 3 months before administration
排除标准
- •With clinically important lung diseases other than asthma that may affect safety or efficacy and evaluated by investigator. This includes lung infection, chronic obstructive pulmonary disease, bronchiectasis, hypersensitivity pneumonitis, pulmonary fibrosis, Allergic bronchopulmonary aspergillosis, etc.
- •With other conditions that could lead to elevated eosinophils such as hypereosinophilic syndromes, eosinophilic granulomatosis with polyangiitis (EGPA), or eosinophilic esophagitis
- •In past 12 months prior to screening，patients has done bronchial thermoplasty or radiotherapy or plan to do it during of the trial
- •with severe cardiac disease or uncontrolled or severe cardiac arrhythmia
- •poorly controlled systemic disease
- •Active infection 7 day before screening
- •Parasitic infection within 6 months before screening
- •At screening, HBsAg or HCV Ab or HIV Ab or TP Ab positive; HBsAg or HCV Ab positive need to be further tested of HBV DNA titer detection or HCV RNA detection (More than normal value range needs to be excluded)
- •Subjects who have received any monoclonal antibody treatment of anti IL-4Ror anti-IL-5/5R
- •Vaccination history with live vaccines (including live attenuated vaccines) within 4 weeks before screening, or plan to receive during of the trial
- •Participated in any interventional clinical trial and received intervention within 3 months before screening
研究组 & 干预措施
610 300mg group
610 300mg administered subcutaneously every 4 weeks
干预措施: 610 300mg group (Drug)
610 30mg group
610 30 mg administered subcutaneously every 4 weeks
干预措施: 610 30mg group (Drug)
610 100mg group
610 100 mg administered subcutaneously every 4 weeks
干预措施: 610 100mg group (Drug)
Placebo 30mg group
placebo subcutaneous (SC) Q4W，8 times
干预措施: Placebo 30mg group (Other)
Placebo 100mg group
placebo subcutaneous (SC) Q4W，8 times
干预措施: Placebo 100mg group (Other)
Placebo 300mg group
placebo subcutaneous (SC) Q4W，8 times
干预措施: Placebo 300mg group (Other)
结局指标
主要结局
Adverse events(AEs)
时间窗: From Day 0 to Day 308
The incidence and severity of AEs, including SAEs, as well as clinical symptoms, and any abnormalities of vital signs, physical examinations#electrocardiogram#laboratory tests and, etc.
次要结局
- Pharmacokinetics-Tmax(From Day 0 to Day 308)
- Anti-drug-antibody(From Day 0 to Day 308)
- Percentage change from baseline in pre-bronchodilator forced expiratory volume in one second (FEV1)(From Day 0 to Day 308)
- Time to first asthma exacerbation event(From Day 0 to Day 308)
- Pharmacokinetics-AUC0-last(From Day 0 to Day 308)
- Pharmacokinetics-AUC0-inf(From Day 0 to Day 308)
- Number of asthma exacerbation(From Day 0 to Day 308)
- Pharmacokinetics-Cmax(From Day 0 to Day 308)
- Pharmacokinetics-CL/F(From Day 0 to Day 308)
- Pharmacokinetics-t1/2(From Day 0 to Day 308)
- Pharmacodynamics-Eosinophils(From Day 0 to Day 308)
- Changes from baseline in pre-bronchodilator forced expiratory volume in one second (FEV1)(From Day 0 to Day 308)
- Number of asthma exacerbations requiring hospitalization (including intubation and ICU admission) or emergency room visits (not conversion to hospitalization)(From Day 0 to Day 308)
- Number of asthma exacerbations requiring hospitalization (including intubation and ICU admission)(From Day 0 to Day 308)
- Change from baseline in Asthma Control Questionnaire score(From Day 0 to Day 308)
- Change From Baseline in the St. George's Respiratory Questionnaire Total Score(From Day 0 to Day 308)
- Pharmacokinetics-Vz/F(From Day 0 to Day 308)