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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase Ib 9MW1911 | Experimental | 9MW1911 is administered intravenously in a multiple ascending dose pattern in four dose levels. Each level includes 6 patients. |
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| Phase IIa 9MW1911 | Experimental | 9MW1911 is administered intravenously (two doses selected on phase Ib). Each dose level includes up to 18 patients. |
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| Phase Ib Placebo | Placebo Comparator | Placebo is administered intravenously in a multiple ascending dose pattern in four dose levels. Each level includes 2 patients. |
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| Phase IIa Placebo | Placebo Comparator | Placebo is administered intravenously (two doses selected on phase Ib). Each dose level includes up to 6 patients. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 9MW1911 | Drug | Participants will receive IV 9MW1911 every 4 weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Weeks 0, 4, 8, 12, 24 |
| Changes from baseline in post-bronchodilator FEV1. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baogang Hospital (No 3 Hospital Affiliated to Medical College of Inner Mongolia) | Baotou | China | ||||
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| Placebo | Drug | Participants will receive IV placebo every 4 weeks. |
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Changes in post-bronchodilator FEV1 levels at 4, 8, 12, and 24 weeks compared to baseline. |
| Weeks 0, 4, 8, 12, 24 |
| 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. | Weeks 0, 4, 8, 12, 24 |
| 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. | Baseline to week 24. |
| Annualized rate of moderate to severe AECOPD over the 24-week treatment period. | 24 weeks |
| 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. | Weeks 0, 12, 24 |
| 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. | Weeks 0, 12, 24 |
| Incidence of ADAs Against 9MW1911. | The incidence of ADAs against 9MW1911 during the study will be summarized. | 36 weeks |
| 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 |