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

NCT06175351 | Active Not Recruiting Phase 1

• 1 other identifier: 9MW1911-2022-CP103
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 22

Brief 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.

Conditions

Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

Outcome Measures

Primary Outcomes (7)

• Pharmacokinetic characteristics.

  Peak concentration (Cmax)

  36 weeks

• Pharmacokinetic characteristics.

  Time to peak concentration (Tmax)

  36 weeks

• Pharmacokinetic characteristics.

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

  36 weeks

• Pharmacokinetic characteristics.

  Elimination half-life (t1/2)

  36 weeks

• Pharmacokinetic characteristics.

  Accumulation ratio based on AUC (Rac (AUC))

  36 weeks

• Pharmacokinetic characteristics.

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

  36 weeks

• Safety and tolerability

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

  36 weeks

Secondary Outcomes (8)

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

  Weeks 0, 4, 8, 12, 24

• Changes from baseline in post-bronchodilator FEV1.

  Weeks 0, 4, 8, 12, 24

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

  Weeks 0, 4, 8, 12, 24

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

  Baseline to week 24.

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

  24 weeks

Study Arms (4)

Phase Ib 9MW1911

EXPERIMENTAL

9MW1911 is administered intravenously in a multiple ascending dose pattern in four dose levels. Each level includes 6 patients.

Drug: 9MW1911

Phase IIa 9MW1911

EXPERIMENTAL

9MW1911 is administered intravenously (two doses selected on phase Ib). Each dose level includes up to 18 patients.

Drug: 9MW1911

Phase Ib Placebo

PLACEBO COMPARATOR

Placebo is administered intravenously in a multiple ascending dose pattern in four dose levels. Each level includes 2 patients.

Drug: Placebo

Phase IIa Placebo

PLACEBO COMPARATOR

Placebo is administered intravenously (two doses selected on phase Ib). Each dose level includes up to 6 patients.

Drug: Placebo

Interventions

9MW1911 DRUG

Participants will receive IV 9MW1911 every 4 weeks.

Phase IIa 9MW1911; Phase Ib 9MW1911

Placebo DRUG

Participants will receive IV placebo every 4 weeks.

Phase IIa Placebo; Phase Ib Placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Mabwell (Shanghai) Bioscience Co., Ltd.: lead

Study Sites (22)

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

Baotou, China

Location

China-Japan Friendship Hospital

Beijing, China

Location

Peking University Shougang Hospital

Beijing, China

Location

The First Hospital of Changsha

Changsha, China

Location

The second xiangya hospital of central south university

Changsha, China

Location

Chengdu Fifth People's Hospital

Chengdu, China

Location

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

Chongqing, China

Location

Fu Yang People's Hospital

Fuyang, China

Location

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, China

Location

The Third Affiliated Hospital of Guangzhou Medical University

Guangzhou, China

Location

The Second Hospital, University of South China

Hengyang, China

Location

The Third People's Hospital of Huizhou

Huizhou, China

Location

Jiangmen Central Hospital

Jiangmen, China

Location

Liaocheng People's Hospital

Liaocheng, China

Location

The First Affiliated Hospital of Nanchang University

Nanchang, China

Location

Pingxiang People's Hospital

Pingxiang, China

Location

The First Affiliated Hospital of Qiqihar Medical University

Qiqihar, China

Location

Tongji Hospital of Tongji University

Shanghai, China

Location

Shengjing Hospital of China Medical University

Shenyang, China

Location

Suzhou Municipal Hospital

Suzhou, China

Location

The First Hospital of Shanxi Medical University

Taiyuan, China

Location

Taizhou Hospital of Zhejiang Province

Taizhou, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2023
• First Posted: December 18, 2023
• Study Start: July 6, 2023
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: May 20, 2025

Record last verified: 2025-05

Locations

CN (22)