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Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)Phase 1/2NCT06175351

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

A Phase 1/2 study testing 9MW1911 in people with Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD), run by Mabwell (Shanghai) Bioscience Co., Ltd. at 22 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 years and older
What is being tested?
9MW1911
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
80 participants
Where
22 sitesChina
Study dates
6 Jul 2023to 30 Sep 2025
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 9Show fewer
  • 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.

Who cannot join

  • Current diagnosis of asthma according to the Global Initiative for Asthma guidelines or other accepted guidelines, or documented history of asthma.
  • Diagnosis of Alpha-1 Antitrypsin Deficiency.
  • 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.
  • 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.
Show all 26Show fewer
  • COVID-19 vaccination injection within 14 days before randomization.
  • Long-term treatment with oxygen (oxygen therapy time >15h/day), or treatment with mechanical ventilation
  • 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.
  • 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.
  • Uncontrolled hypertension (ie, systolic blood pressure>180 mmHg or diastolic blood pressure >110 mmHg with or without use of anti-hypertensive therapy).
  • 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.
  • 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).
  • 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.
  • History of systemic allergic reaction (including systemic allergic reaction to any biological therapy), or history of immediate allergic reaction to any biological therapy.
  • Participation in an interventional clinical studies within 3 months that could affect the result of this study.
  • 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.
  • 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.
  • 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.

Trial locations and contacts

22 sites in 1 country.

22 sites in 1 country

China22 sites

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

    Baotou

  • China-Japan Friendship Hospital

    Beijing

  • Peking University Shougang Hospital

    Beijing

  • The First Hospital of Changsha

    Changsha

  • The second xiangya hospital of central south university

    Changsha

  • Chengdu Fifth People's Hospital

    Chengdu

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

    Chongqing

  • Fu Yang People's Hospital

    Fuyang

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou

  • The Third Affiliated Hospital of Guangzhou Medical University

    Guangzhou

  • The Second Hospital, University of South China

    Hengyang

  • The Third People's Hospital of Huizhou

    Huizhou

  • Jiangmen Central Hospital

    Jiangmen

  • Liaocheng People's Hospital

    Liaocheng

  • The First Affiliated Hospital of Nanchang University

    Nanchang

  • Pingxiang People's Hospital

    Pingxiang

  • The First Affiliated Hospital of Qiqihar Medical University

    Qiqihar

  • Tongji Hospital of Tongji University

    Shanghai

  • Shengjing Hospital of China Medical University

    Shenyang

  • Suzhou Municipal Hospital

    Suzhou

  • The First Hospital of Shanxi Medical University

    Taiyuan

  • Taizhou Hospital of Zhejiang Province

    Taizhou

Other trials in China

About this study

Official title: 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)

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.

Being tested
9MW1911, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 9MW1911Drug

    Participants will receive IV 9MW1911 every 4 weeks.

  • PlaceboDrug

    Participants will receive IV placebo every 4 weeks.

Study groups in NCT06175351
Study groupRoleWhat they receive
Phase Ib 9MW1911Experimental9MW1911 is administered intravenously in a multiple ascending dose pattern in four dose levels. Each level includes 6 patients.
Receives: Drug: 9MW1911
Phase IIa 9MW1911Experimental9MW1911 is administered intravenously (two doses selected on phase Ib). Each dose level includes up to 18 patients.
Receives: Drug: 9MW1911
Phase Ib PlaceboPlacebo comparatorPlacebo is administered intravenously in a multiple ascending dose pattern in four dose levels. Each level includes 2 patients.
Receives: Drug: Placebo
Phase IIa PlaceboPlacebo comparatorPlacebo is administered intravenously (two doses selected on phase Ib). Each dose level includes up to 6 patients.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pharmacokinetic characteristics.

    Peak concentration (Cmax)

    Measured: 36 weeks

  2. Pharmacokinetic characteristics.

    Time to peak concentration (Tmax)

    Measured: 36 weeks

  3. Pharmacokinetic characteristics.

    Area under the drug concentration-time curve from time zero to the last measurable concentration time (AUC0-t)

    Measured: 36 weeks

  4. Pharmacokinetic characteristics.

    Elimination half-life (t1/2)

    Measured: 36 weeks

  5. Pharmacokinetic characteristics.

    Accumulation ratio based on AUC (Rac (AUC))

    Measured: 36 weeks

  6. Pharmacokinetic characteristics.

    Accumulation ratio based on peak concentration (Rac (Cmax))

    Measured: 36 weeks

  7. Safety and tolerability

    The incidence of AEs (adverse events) and SAEs (serious adverse events) from treatment until the last scheduled follow-up visit

    Measured: 36 weeks

Secondary outcomes (8)

  1. Changes from baseline in pre-bronchodilator FEV1 (forced expiratory volume at one second).

    Changes in pre-bronchodilator FEV1 levels at 4, 8, 12, and 24 weeks compared to baseline.

    Measured: Weeks 0, 4, 8, 12, 24

  2. Changes from baseline in post-bronchodilator FEV1.

    Changes in post-bronchodilator FEV1 levels at 4, 8, 12, and 24 weeks compared to baseline.

    Measured: Weeks 0, 4, 8, 12, 24

  3. Changes from baseline in post-brochodilator FEV1(%pred).

    Changes in post-brochodilator FEV1(%pred) levels at 4, 8, 12, and 24 weeks compared to baseline.

    Measured: Weeks 0, 4, 8, 12, 24

  4. Time to first moderate to severe Chronic Obstructive Pulmonary Disease Acute Exacerbation (AECOPD) from baseline to week 24.

    Time to first moderate to severe Chronic Obstructive Pulmonary Disease Acute Exacerbation (AECOPD) from baseline to week 24.

    Measured: Baseline to week 24.

  5. Annualized rate of moderate to severe AECOPD over the 24-week treatment period.

    Measured: 24 weeks

  6. Changes from baseline in mMRC(Modified Medical Research Council) dyspnea scale at 12 and 24 weeks.

    Changes in mMRC dyspnea scale at 12 and 24 weeks compared to baseline.

    Measured: Weeks 0, 12, 24

  7. Changes from baseline in CAT(COPD Assessment Test) score at 12 and 24 weeks.

    Changes in CAT score at 12 and 24 weeks compared to baseline.

    Measured: Weeks 0, 12, 24

  8. Incidence of ADAs Against 9MW1911.

    The incidence of ADAs against 9MW1911 during the study will be summarized.

    Measured: 36 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Dec 2023
  2. Study start6 Jul 2023
  3. Primary completion30 Sep 2025 (estimated)
  4. Study completion30 Sep 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06175351
Sponsor's protocol ID
9MW1911-2022-CP103
Status last verified
May 2025
First submitted
4 Dec 2023
Last updated
20 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing 9MW1911 in people with Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD), run by Mabwell (Shanghai) Bioscience Co., Ltd. at 22 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 20 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pharmacokinetic characteristics. (time frame: 36 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06175351.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2025.

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