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

Last updated: December 14, 2023
Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd.
Overall Status: Active - Recruiting

Phase

1/2

Condition

N/A

Treatment

Placebo

9MW1911

Clinical Study ID

NCT06175351
9MW1911-2022-CP103
  • Ages > 40
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  1. Male or female patients must be >=40 years of age and capable of giving signedinformed 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 ascore >=2.
  8. Documented stable, standard-of-care COPD maintenance therapy for at least 8 weeksprior to screening, with no anticipated changes during the screening period andthroughout the study.
  9. Documented history of >= 2 moderate or >=1 severe COPD exacerbations within 12 monthsprior to screening.

Exclusion

Exclusion Criteria:

  1. Current diagnosis of asthma according to the Global Initiative for Asthma guidelinesor 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 toscreening.
  5. Clinically significant respiratory disease other than COPD that significantly affectthe study.
  6. Evidence of active injection with Mycobacterium tuberculosis or nontuberculousmycobacteria, latent, or inadequately treated infection with Mycobacteriumtuberculosis.
  7. COVID-19 vaccination injection within 14 days before randomization.
  8. Long-term treatment with oxygen (oxygen therapy time >15h/day), or treatment withmechanical 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 weeksof screening.
  11. Clinically significant abnormal electrocardiogram (ECG) at randomization that mayaffect the conduct of the study.
  12. Myocardial infarction, unstable angina, or stroke occurring within 12 months prior toscreening;
  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 bloodpressure >110 mmHg with or without use of anti-hypertensive therapy).
  15. Treatment with other biological agents (including anti-IL4, IL-5, IL-13 monoclonalantibodies) 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 undefinedneoplasms.
  18. Positive test for Hepatitis B surface antigen (HbsAg), Hepatitis C virus antibody (HCVAb), Syphilis Treponema pallidum antibody (Syphilis TP), or Human ImmunodeficiencyVirus (HIV Ag/Ab).
  19. Alanine aminotransferase (ALT) >= 2 times the upper limit of normal (ULN); Aspartateaminotransferase (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 anybiological therapy), or history of immediate allergic reaction to any biologicaltherapy.
  22. Participation in an interventional clinical studies within 3 months that could affectthe result of this study.
  23. Pregnant or lactating women. Women of child-bearing potential (WOCBP) with a positiveblood serum pregnancy test at screening. Planning a pregnancy during the interventionperiod and for at least 20 weeks after the last dose of study intervention. Subjectsof child-bearing potential (including female subjects, male subjects and their femalepartners of child-bearing potential) unable to use reliable contraception during theintervention period and for at least 20 weeks after the last dose of studyintervention.
  24. Confirmed COVID-19 infection at screening. Known history of COVID-19 infection within 4 weeks prior to screening. History of requiring mechanical ventilation orextracorporeal membrane oxygenation (ECMO) secondary to COVID-19 within 3 months priorto screening. Participants who have had a COVID-19 infection prior screening have notyet 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 asdetermined by the investigator.

Study Design

Total Participants: 80
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 1/2
Study Start date:
July 06, 2023
Estimated Completion Date:
September 30, 2025

Connect with a study center

  • Baogang Hospital (No 3 Hospital Affiliated to Medical College of Inner Mongolia)

    Baotou,
    China

    Active - Recruiting

  • China-Japan Friendship Hospital

    Beijing,
    China

    Active - Recruiting

  • Peking University Shougang Hospital

    Beijing,
    China

    Active - Recruiting

  • The First Hospital of Changsha

    Changsha,
    China

    Active - Recruiting

  • The second xiangya hospital of central south university

    Changsha,
    China

    Active - Recruiting

  • Chengdu Fifth People's Hospital

    Chengdu,
    China

    Active - Recruiting

  • Chongqing Red Cross Hospital (People's Hospital of Jiangbei District)

    Chongqing,
    China

    Active - Recruiting

  • Fu Yang People's Hospital

    Fuyang,
    China

    Active - Recruiting

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou,
    China

    Active - Recruiting

  • The Third Affiliated Hospital of Guangzhou Medical University

    Guangzhou,
    China

    Active - Recruiting

  • The Second Hospital, University of South China

    Hengyang,
    China

    Active - Recruiting

  • The Third People's Hospital of Huizhou

    Huizhou,
    China

    Active - Recruiting

  • Jiangmen Central Hospital

    Jiangmen,
    China

    Active - Recruiting

  • Liaocheng People's Hospital

    Liaocheng,
    China

    Active - Recruiting

  • The First Affiliated Hospital of Nanchang University

    Nanchang,
    China

    Active - Recruiting

  • Pingxiang People's Hospital

    Pingxiang,
    China

    Active - Recruiting

  • The First Affiliated Hospital of Qiqihar Medical University

    Qiqihar,
    China

    Active - Recruiting

  • Tongji Hospital of Tongji University

    Shanghai,
    China

    Active - Recruiting

  • Shengjing Hospital of China Medical University

    Shenyang,
    China

    Active - Recruiting

  • Suzhou Municipal Hospital

    Suzhou,
    China

    Active - Recruiting

  • The First Hospital of Shanxi Medical University

    Taiyuan,
    China

    Active - Recruiting

  • Taizhou Hospital of Zhejiang Province

    Taizhou,
    China

    Active - Recruiting

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