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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
80
Baogang Hospital (No 3 Hospital Affiliated to Medical College of Inner Mongolia)
Baotou, China
Pharmacokinetic characteristics.
Peak concentration (Cmax)
Time frame: 36 weeks
Pharmacokinetic characteristics.
Time to peak concentration (Tmax)
Time frame: 36 weeks
Pharmacokinetic characteristics.
Area under the drug concentration-time curve from time zero to the last measurable concentration time (AUC0-t)
Time frame: 36 weeks
Pharmacokinetic characteristics.
Elimination half-life (t1/2)
Time frame: 36 weeks
Pharmacokinetic characteristics.
Accumulation ratio based on AUC (Rac (AUC))
Time frame: 36 weeks
Pharmacokinetic characteristics.
Accumulation ratio based on peak concentration (Rac (Cmax))
Time frame: 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
Time frame: 36 weeks
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.
Time frame: Weeks 0, 4, 8, 12, 24
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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
...and 12 more locations
Changes from baseline in post-bronchodilator FEV1.
Changes in post-bronchodilator FEV1 levels at 4, 8, 12, and 24 weeks compared to baseline.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to week 24.
Annualized rate of moderate to severe AECOPD over the 24-week treatment period.
Time frame: 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.
Time frame: 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.
Time frame: Weeks 0, 12, 24
Incidence of ADAs Against 9MW1911.
The incidence of ADAs against 9MW1911 during the study will be summarized.
Time frame: 36 weeks