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Study to Evaluate the Pharmacokinetic Characteristics, Safety, Tolerability, and Preliminary Efficacy of 9MW1911 in Patients With Chronic Obstructive Pulmonary Disease (COPD).
Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd.
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.
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)
Key Details
Gender
All
Age Range
40 Years - Any
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2023-07-06
Completion Date
2025-09-30
Last Updated
2025-05-20
Healthy Volunteers
No
Interventions
9MW1911
Participants will receive IV 9MW1911 every 4 weeks.
Placebo
Participants will receive IV placebo every 4 weeks.
Locations (22)
Baogang Hospital (No 3 Hospital Affiliated to Medical College of Inner Mongolia)
Baotou, China
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