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ACTIVE NOT RECRUITING
NCT06175351
PHASE1/PHASE2

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.

View on ClinicalTrials.gov

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

DRUG

9MW1911

Participants will receive IV 9MW1911 every 4 weeks.

DRUG

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