Study to Evaluate the Pharmacokinetic Characteristics, Safety, Tolerability, and Preliminary Efficacy of 9MW1911 in Patients With Chronic Obstructive Pulmonary Disease (COPD).
Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Investigational drug(s) / intervention(s)
9MW1911Placebo
9MW1911: Participants will receive IV 9MW1911 every 4 weeks.
Placebo: Participants will receive IV placebo every 4 weeks.
Study summary
The study will evaluate the pharmacokinetic characteristics, safety, tolerability, and preliminary efficacy of 9MW1911 in combination with standard of care COPD maintenance therapy in patients with moderate to severe COPD.
Eligibility
Sex
ALL
Min age
40 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Male or female patients must be \>=40 years of age and capable of giving signed informed consent.
2. Body Mass Index (BMI) of 16 kg/m² to 32 kg/m².
3. Documented physician diagnosis of COPD for at least 1 year.
4. Smoking history with a minimum of 10 pack-year.
5. Post-bronchodilator of FEV1\>=30 and \<80% of predicted normal value at screening.
6. Modified Medical Research Council (dyspnea scale) (mMRC) score\>=2.
7. COPD assessment score (CAT) score \>=10, with each of the phlegm and cough items with a score \>=2.
8. 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.
9. Documented history of \>= 2 moderate or \>=1 severe COPD exacerbations within 12 months prior to screening.
Exclusion Criteria:
1. Current diagnosis of asthma according to the Global Initiative for Asthma guidelines or other accepted guidelines, or documented history of asthma.
2. Diagnosis of Alpha-1 Antitrypsin Deficiency.
3. Moderate to severe COPD exacerbation, within 4 weeks prior to randomization.
4. History of lung pneumonectomy, or lung volume reduction within 12 months prior to screening.
5. Clinically significant respiratory disease other than COPD that significantly affect the study.
6. Evidence of active injection with Mycobacterium tuberculosis or nontuberculous mycobacteria, latent, or inadequately treated infection with Mycobacterium tuberculosis.
7. COVID-19 vaccination injection within 14 days before randomization.
8. Long-term treatment with oxygen (oxygen therapy time \>15h/day), or treatment with mechanical ventilation
9. Clinically significant sleep apnea requiring continuous positive airway pressure (CPAP) or non-invasive positive pressure ventilation (NIPPV).
10. Participating in, or scheduled for a pulmonary rehabilitation program within 4 weeks of screening.
11. Clinically significant abnormal electrocardiogram (ECG) at randomization that may affect the conduct of the study.
12. Myocardial infarction, unstable angina, or stroke occurring within 12 months prior to screening;
13. Heart failure (NYHA Class III or IV) within 6 months prior to screening.
14. Uncontrolled hypertension (ie, systolic blood pressure\>180 mmHg or diastolic blood pressure \>110 mmHg with or without use of anti-hypertensive therapy).
15. Treatment with other biological agents (including anti-IL4, IL-5, IL-13 monoclonal antibodies) or immunosuppressive therapy within 2 months prior to screening.
16. Alcohol or drug abuse within 1 year prior to screening.
17. Malignancy, current or within the past 5 years. Suspected malignancy or undefined neoplasms.
18. 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).
19. Alanine aminotransferase (ALT) \>= 2 times the upper limit of normal (ULN); Aspartate aminotransferase (AST) \>= 2 times ULN; Total bilirubin \>= 1.5 times ULN.
20. Estimated glomerular filtration rate (eGFR) \<60 mL/min/1.73m2.
21. History of systemic allergic reaction (including systemic allergic reaction to any biological therapy), or history of immediate allergic reaction to any biological therapy.
22. Participation in an interventional clinical studies within 3 months that could affect the result of this study.
23. 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.
24. 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.
25. Life expectancy of no more than 12 months.
26. Subjects who is inappropriate to participate in the trial due to any reasons as determined by the investigator.
Pharmacokinetic characteristics. — 36 weeks Time to peak concentration (Tmax)
Pharmacokinetic characteristics. — 36 weeks Area under the drug concentration-time curve from time zero to the last measurable concentration time (AUC0-t)
Pharmacokinetic characteristics. — 36 weeks Accumulation ratio based on AUC (Rac (AUC))
Pharmacokinetic characteristics. — 36 weeks Accumulation ratio based on peak concentration (Rac (Cmax))
Safety and tolerability — 36 weeks The incidence of AEs (adverse events) and SAEs (serious adverse events) from treatment until the last scheduled follow-up visit
Trial sites (22)
Facility
City
Region
Status
Baogang Hospital (No 3 Hospital Affiliated to Medical College of Inner Mongolia)
Baotou
China
China-Japan Friendship Hospital
Beijing
China
Peking University Shougang Hospital
Beijing
China
The First Hospital of Changsha
Changsha
China
The second xiangya hospital of central south university
Changsha
China
Chengdu Fifth People's Hospital
Chengdu
China
Chongqing Red Cross Hospital (People's Hospital of Jiangbei District)
Chongqing
China
Fu Yang People's Hospital
Fuyang
China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou
China
The Third Affiliated Hospital of Guangzhou Medical University
Guangzhou
China
The Second Hospital, University of South China
Hengyang
China
The Third People's Hospital of Huizhou
Huizhou
China
Jiangmen Central Hospital
Jiangmen
China
Liaocheng People's Hospital
Liaocheng
China
The First Affiliated Hospital of Nanchang University
Nanchang
China
Pingxiang People's Hospital
Pingxiang
China
The First Affiliated Hospital of Qiqihar Medical University
Qiqihar
China
Tongji Hospital of Tongji University
Shanghai
China
Shengjing Hospital of China Medical University
Shenyang
China
Suzhou Municipal Hospital
Suzhou
China
The First Hospital of Shanxi Medical University
Taiyuan
China
Taizhou Hospital of Zhejiang Province
Taizhou
China
More Mabwell (Shanghai) Bioscience Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.