Phase Ib/II Clinical Trial of Safety, Pharmacokinetics and Preliminary Efficacy of MG-K10 Humanized Monoclonal Antibody Injection in Adult Asthmatic Subjects
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Absolute Change from baseline in pre-bronchodilator FEV1
研究概览
简要总结
This study is a phase Ib/II clinical trial conducted in Chinese adult asthmatic subjects to evaluate the preliminary efficacy and safety of MG-K10 humanized monoclonal antibody injection in the treatment of asthma.
详细描述
The study was conducted in two phases: the Phase Ib study focused on the safety and tolerability of MG-K10 in adult asthma subjects. Phase II study focused on the preliminary efficacy in adults with moderate to severe asthma.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Asthma diagnosed according to the 2021 version of the GINA guidelines for at least 1 year;
- •1 second forced expiratory volume (FEV1) before randomization before bronchodilator use The measured value is ≤80% of the normal predicted value;
- •Must have experienced at least one severe acute asthma attack within 12 months outbreak event.
- •Positive bronchodilator test
- •Subjects and partners agree to take effective contraceptive measures from signing the Informed Consent Form (ICF) to 6 months after the end of treatment
排除标准
- •Clinical diagnosis of chronic obstructive pulmonary disease (COPD) or other lung diseases that may impair lung function
- •Subjects with malignant tumor within 5 years
- •Received biologics with the same therapeutic purpose within 6 months prior to screening,
- •Women who are breastfeeding or pregnant, or who plan to become pregnant or breastfeeding during the study period;
研究组 & 干预措施
MG-K10 Q2W
Received MG-K10 300 mg subcutaneous injection every 2 weeks
干预措施: MG-K10 (Drug)
MG-K10 Q4W
Received MG-K10 300 mg subcutaneous injection every 4 weeks
干预措施: MG-K10 (Drug)
MG-K10 Q4W
Received MG-K10 300 mg subcutaneous injection every 4 weeks
干预措施: Placebo (Drug)
Placebo
The placebo group will receive 2 ml of placebo subcutaneously administered every 2 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Absolute Change from baseline in pre-bronchodilator FEV1
时间窗: 12 week
Absolute change from baseline in pre-bronchodilator FEV1 in each study group at 12 week of MG-K10 treatment compared with placebo
次要结局
- Absolute Change from baseline in pre-bronchodilator FEV1(4,8,16,20,24,28,32 week)
- the Annualized rate of severe asthma acute event(24 weeks and 25 to 32 weeks)
- peak morning and evening expiratory flow (PEF)(4,8,12,16,20,24,28,32 week)
- Annualized rate of the event of loss of asthma control (LOAC)(24 weeks and 25 to 32 weeks)
- Time of the first severe asthma acute event(32 weeks)
- Percent change from baseline in pre-bronchodilator FEV1(4,8,16,20,24,28,32 week)
- Time of first loss of asthma control (LOAC)(32weeks)
- asthma Control Questionnaire 5 (ACQ-5 score 0-30) changes in score(4, 8, 12, 16, 20, 24, 28, and 32 weeks)
- thymus activation regulated chemokine (TARC)(32 weeks)
- Pharmacokinetic concentration(32 weeks)
- serum immunoglobulin E (IgE)(32 weeks)
- Morning/evening asthma symptom score(24 and 32 week)
- Daily use of first aid medicine spray(24 and 32 week)
- Incidence of Adverse events (AEs)(32 weeks)
- Fractional exhaled nitric oxide (FeNO)(32 weeks)
- Anti-drug antibodies (ADAs) and neutralizing antibodies (Nabs)(32 weeks)