NCT06175351

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

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)

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd. · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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)

Interventions

Type	Name	Description
DRUG	9MW1911	Participants will receive IV 9MW1911 every 4 weeks.
DRUG	Placebo	Participants will receive IV placebo every 4 weeks.

Timeline

• Start date: 2023-07-06
• Primary completion: 2025-09-30
• Completion: 2025-09-30
• First posted: 2023-12-18
• Last updated: 2025-05-20

Locations

22 sites across 1 country: China