A Clinical Trial to Evaluate the Efficacy and Safety of HRS-9821 Inhalation Suspension in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

Starting soon · Phase 2 · Has a placebo group

Conditions studied: COPD

In brief

The study is being conducted to evaluate the efficacy and safety of HRS-9821 for patients with COPD, and to explore the reasonable dosage of HRS-9821 for patients with COPD.

Key facts

Study ID

NCT07640451

Run by

Guangdong Hengrui Pharmaceutical Co., Ltd

People needed

90

Starts

2026-06-01

Expected to finish

2026-11-01

Last updated by the study team

2026-06-10

Who can join

Age: 40 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 40 years old and < 80 years old, male or female.
• Meet the weight standard.
• Smoking history ≥ 10 pack-years.
• COPD has been diagnosed ≥ 1 year.
• 4 weeks before screening, the background treatment for COPD was stable.
• FEV1/FVC < 0.7, 30% ≤ FEV1 ≤ 80%.
• mMRC score ≥ 2.
• The inspection and medication can be completed as required.
• Non-pregnant and breastfeeding state.
• Able and willing to provide a written informed consent.

You may not qualify if…

• History of life-threatening COPD.
• Other pulmonary diseases that may affect the efficacy evaluation of this study.
• Concurrent diseases other than COPD that may affect lung function.
• History of asthma.
• Pulmonary heart disease requiring clinical intervention, or moderate to severe pulmonary hypertension.
• Malignant tumors within 5 years.
• Uncontrolled severe cardiovascular and cerebrovascular diseases within 1 year.
• Unstable diseases.
• Acute exacerbation of COPD within 12 weeks, hospitalization for COPD or pneumonia within 6 months.
• Infection in the lungs or other parts occurs within 16 weeks and requires treatment.
• Immunosuppression.
• Uncontrolled hypertension.
• Lung resection, surgical lung volume reduction or endoscopic treatment for COPD.
• Undergone major surgery or planned surgery within 14 months.
• Abnormal chest images have clinical significance.
• Tuberculosis infection requiring treatment within 16 to 12 months.
• Virological test result was positive.
• Laboratory blood tests and electrocardiograms were significantly abnormal.
• Requires oxygen inhalation or intermittent oxygen inhalation therapy.
• Hypercapnia, using or requiring long-term use of any non-invasive positive pressure ventilation device.
• Biological agents that may have therapeutic effects on the studied disease have been used within 12 weeks or within 5 half-lives of the drug.
• Vaccination, theophylline or drugs within 4 weeks.
• Having participated in other clinical studies within 4 weeks and used research drugs or medical devices containing active ingredients, or still within 5 half-lives of the research drug.
• Systemic glucocorticoids, immunosuppressants, and oral Roflumilast within 12 weeks.
• Undergoing or planning rehabilitation treatment for pulmonary rehabilitation.

Where it is running

• Shanghai Tongji Hospital — Shanghai, Shanghai Municipality, China

Full record on ClinicalTrials.gov

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