NCT06175351Active, not recruitingPhase 1/2
Study to Evaluate the Pharmacokinetic Characteristics, Safety, Tolerability, and Preliminary Efficacy of 9MW1911 in Patients With Chronic Obstructive Pulmonary Disease (COPD).
A Randomized, Double-Blind, Placebo-Controlled Phase Ib/IIa Clinical Study to Evaluate the Pharmacokinetic Characteristics, Safety, Tolerability, and Preliminary Efficacy of 9MW1911 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Source: ClinicalTrials.gov · Last updated 20 May 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 4 Dec 2023
- Start date
- 6 Jul 2023
- Primary completion date
- 30 Sept 2025
- Lead sponsor
- Mabwell (Shanghai) Bioscience Co., Ltd.
- Diseases
- COPD
- NCT number
- NCT06175351
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 80
- From 6 Jul 2023 to the primary completion date, 30 Sept 2025
- 22 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Lab values
- 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.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 40 years to - · Sex: All · Does not accept healthy volunteers
Sites (22)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Baogang Hospital (No 3 Hospital Affiliated to Medical College of Inner Mongolia) Coordinator of this site? Confirm its status | Baotou | China | Unknown status |
| China-Japan Friendship Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Peking University Shougang Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| The First Hospital of Changsha Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| The Second Xiangya Hospital of Central South University Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| Chengdu Fifth People's Hospital Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| Chongqing Red Cross Hospital (People's Hospital of Jiangbei District) Coordinator of this site? Confirm its status | Chongqing | China | Unknown status |
| Fu Yang People's Hospital Coordinator of this site? Confirm its status | Fuyang | China | Unknown status |
| The Third Affiliated Hospital of Guangzhou Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| The First Affiliated Hospital of Guangzhou Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| The Second Hospital University of South China Coordinator of this site? Confirm its status | Hengyang | China | Unknown status |
| The Third People's Hospital of Huizhou Coordinator of this site? Confirm its status | Huizhou | China | Unknown status |
| Jiangmen Central Hospital Coordinator of this site? Confirm its status | Jiangmen | China | Unknown status |
| Liaocheng People's Hospital Coordinator of this site? Confirm its status | Liaocheng | China | Unknown status |
| The First Affiliated Hospital of NanChang University Coordinator of this site? Confirm its status | Nanchang | China | Unknown status |
| Pingxiang People's Hospital Coordinator of this site? Confirm its status | Pingxiang | China | Unknown status |
| The First Affiliated Hospital of Qiqihar Medical University Coordinator of this site? Confirm its status | Qiqihar | China | Unknown status |
| Tongji Hospital of Tongji University Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Shengjing Hospital Of China Medical University Coordinator of this site? Confirm its status | Shenyang | China | Unknown status |
| Suzhou Municipal Hospital Coordinator of this site? Confirm its status | Suzhou | China | Unknown status |
| The First Hospital of Shanxi Medical University Coordinator of this site? Confirm its status | Taiyuan | China | Unknown status |
| Taizhou Hospital of Zhejiang Province Coordinator of this site? Confirm its status | Taizhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.