Study to Evaluate the Pharmacokinetic Characteristics, Safety, Tolerability, and Preliminary Efficacy of 9MW1911 in Patients With Chronic Obstructive Pulmonary Disease (COPD).

Korábbi kezelés

• Moderate to severe COPD exacerbation, within 4 weeks prior to randomization.
• History of lung pneumonectomy, or lung volume reduction within 12 months prior to screening.
• COVID-19 vaccination injection within 14 days before randomization.
• Long-term treatment with oxygen (oxygen therapy time >15h/day), or treatment with mechanical ventilation
• Myocardial infarction, unstable angina, or stroke occurring within 12 months prior to screening;
• Heart failure (NYHA Class III or IV) within 6 months prior to screening.
• Treatment with other biological agents (including anti-IL4, IL-5, IL-13 monoclonal antibodies) or immunosuppressive therapy within 2 months prior to screening.
• Alcohol or drug abuse within 1 year prior to screening.
• Confirmed COVID-19 infection at screening. Known history of COVID-19 infection within 4 weeks prior to screening. History of requiring mechanical ventilation or extracorporeal membrane oxygenation (ECMO) secondary to COVID-19 within 3 months prior to screening. Participants who have had a COVID-19 infection prior screening have not yet sufficiently recovered to participate in the procedures of a clinical trial.

Más betegség

• Current diagnosis of asthma according to the Global Initiative for Asthma guidelines or other accepted guidelines, or documented history of asthma.
• Clinically significant respiratory disease other than COPD that significantly affect the study.
• Evidence of active injection with Mycobacterium tuberculosis or nontuberculous mycobacteria, latent, or inadequately treated infection with Mycobacterium tuberculosis.
• Uncontrolled hypertension (ie, systolic blood pressure>180 mmHg or diastolic blood pressure >110 mmHg with or without use of anti-hypertensive therapy).
• Malignancy, current or within the past 5 years. Suspected malignancy or undefined neoplasms.
• Positive test for Hepatitis B surface antigen (HbsAg), Hepatitis C virus antibody (HCVAb), Syphilis Treponema pallidum antibody (Syphilis TP), or Human Immunodeficiency Virus (HIV Ag/Ab).
• History of systemic allergic reaction (including systemic allergic reaction to any biological therapy), or history of immediate allergic reaction to any biological therapy.

Laborértékek

• Alanine aminotransferase (ALT) >= 2 times the upper limit of normal (ULN); Aspartate aminotransferase (AST) >= 2 times ULN; Total bilirubin >= 1.5 times ULN.
• Estimated glomerular filtration rate (eGFR) <60 mL/min/1.73m2.
• Pregnant or lactating women. Women of child-bearing potential (WOCBP) with a positive blood serum pregnancy test at screening. Planning a pregnancy during the intervention period and for at least 20 weeks after the last dose of study intervention. Subjects of child-bearing potential (including female subjects, male subjects and their female partners of child-bearing potential) unable to use reliable contraception during the intervention period and for at least 20 weeks after the last dose of study intervention.

Egyéb

• Diagnosis of Alpha-1 Antitrypsin Deficiency.
• Clinically significant sleep apnea requiring continuous positive airway pressure (CPAP) or non-invasive positive pressure ventilation (NIPPV).
• Participating in, or scheduled for a pulmonary rehabilitation program within 4 weeks of screening.
• Clinically significant abnormal electrocardiogram (ECG) at randomization that may affect the conduct of the study.
• Participation in an interventional clinical studies within 3 months that could affect the result of this study.
• Life expectancy of no more than 12 months.
• Subjects who is inappropriate to participate in the trial due to any reasons as determined by the investigator.

• Male or female patients must be >=40 years of age and capable of giving signed informed consent.
• Body Mass Index (BMI) of 16 kg/m² to 32 kg/m².
• Documented physician diagnosis of COPD for at least 1 year.
• Smoking history with a minimum of 10 pack-year.
• Post-bronchodilator of FEV1>=30 and <80% of predicted normal value at screening.
• Modified Medical Research Council (dyspnea scale) (mMRC) score>=2.
• COPD assessment score (CAT) score >=10, with each of the phlegm and cough items with a score >=2.
• Documented stable, standard-of-care COPD maintenance therapy for at least 8 weeks prior to screening, with no anticipated changes during the screening period and throughout the study.
• Documented history of >= 2 moderate or >=1 severe COPD exacerbations within 12 months prior to screening.