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

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of HRS-9821 Inhalation Suspension in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

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.

Study Overview

• Status: Not yet recruiting
• Conditions: COPD
• Intervention / Treatment: Drug: HRS-9821 Inhalation Suspension; Drug: HRS-9821 Placebo Inhalation Suspension

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Si Chen, M.M; Phone Number: +86-0518-82342973; Email: si.chen.sc96@hengrui.com

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200065
      • Shanghai Tongji Hospital
      • Contact: Jinfu Xu; Phone Number: +86-13321922898; Email: jfxucn@163.com
      • Principal Investigator: Jinfu Xu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age ≥ 40 years old and < 80 years old, male or female.
2. Meet the weight standard.
3. Smoking history ≥ 10 pack-years.
4. COPD has been diagnosed ≥ 1 year.
5. 4 weeks before screening, the background treatment for COPD was stable.
6. FEV1/FVC < 0.7, 30% ≤ FEV1 ≤ 80%.
7. mMRC score ≥ 2.
8. The inspection and medication can be completed as required.
9. Non-pregnant and breastfeeding state.
10. Able and willing to provide a written informed consent.

Exclusion Criteria:

1. History of life-threatening COPD.
2. Other pulmonary diseases that may affect the efficacy evaluation of this study.
3. Concurrent diseases other than COPD that may affect lung function.
4. History of asthma.
5. Pulmonary heart disease requiring clinical intervention, or moderate to severe pulmonary hypertension.
6. Malignant tumors within 5 years.
7. Uncontrolled severe cardiovascular and cerebrovascular diseases within 1 year.
8. Unstable diseases.
9. Acute exacerbation of COPD within 12 weeks, hospitalization for COPD or pneumonia within 6 months.
10. Infection in the lungs or other parts occurs within 16 weeks and requires treatment.
11. Immunosuppression.
12. Uncontrolled hypertension.
13. Lung resection, surgical lung volume reduction or endoscopic treatment for COPD.
14. Undergone major surgery or planned surgery within 14 months.
15. Abnormal chest images have clinical significance.
16. Tuberculosis infection requiring treatment within 16 to 12 months.
17. Virological test result was positive.
18. Laboratory blood tests and electrocardiograms were significantly abnormal.
19. Requires oxygen inhalation or intermittent oxygen inhalation therapy.
20. Hypercapnia, using or requiring long-term use of any non-invasive positive pressure ventilation device.
21. 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.
22. Vaccination, theophylline or drugs within 4 weeks.
23. 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.
24. Systemic glucocorticoids, immunosuppressants, and oral Roflumilast within 12 weeks.
25. Undergoing or planning rehabilitation treatment for pulmonary rehabilitation.
26. Non-selective β blockers within 1 week.
27. Overly potent/moderately potent drugs that inhibit or induce the liver drug-metabolizing enzyme CYP3A4 within 14 days.
28. Allergic to the research drug or salbutamol or excipients.
29. Has been used HRS-9821.
30. Drug abuse and alcohol abuse within 1 year.
31. Pregnant or lactating period or planning to be pregnant or lactating.
32. The researchers judged that there were other unsuitable circumstances.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HRS-9821 Group - Dose 1; HRS-9821 Inhalation Suspension, Dose 1.	Drug: HRS-9821 Inhalation Suspension; HRS-9821 Inhalation Suspension.
Experimental: HRS-9821 Group - Dose 2; HRS-9821 Inhalation Suspension, Dose 2.	Drug: HRS-9821 Inhalation Suspension; HRS-9821 Inhalation Suspension.
Placebo Comparator: HRS-9821 Placebo Group - Dose 1; HRS-9821 Placebo Inhalation Suspension, Dose 1.	Drug: HRS-9821 Placebo Inhalation Suspension; HRS-9821 Placebo Inhalation Suspension.
Placebo Comparator: HRS-9821 Placebo Group - Dose 2; HRS-9821 Placebo Inhalation Suspension, Dose 2.	Drug: HRS-9821 Placebo Inhalation Suspension; HRS-9821 Placebo Inhalation Suspension.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Changes in peak FEV1 (forced expiratory volume in one second) after 28 days of treatment.	From baseline to 28 days after treatment.

Secondary Outcome Measures

Outcome Measure	Time Frame
Changes in FEV1 area under the curve versus time from 0 to 12 hours (AUC0-12h) and 0 to 4 hours (AUC0-4h) after 1, 14 and 28 days of treatment.	During 28 days of treatment.
Changes in peak FEV1 after 1 and 14 days of treatment.	After 1 and 14 days of treatment.
Changes in trough FEV1 after 1, 14 and 28 days of treatment.	After 1, 14 and 28 days of treatment.
Changes in FVC (forced vital capacity) during 28 days of treatment.	During 28 days of treatment.
Changes of in SGRQ (St. George's Respiratory Questionnaire), CAT (COPD Assessment Test), mMRC (modified Medical Research Council） score during 28 days of treatment.	During 28 days of treatment.
The use of SABA (Short-Acting Beta₂ Agonist) during 28 days of treatment.	During 28 days of treatment.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence and severity of adverse events (AEs) during the 7-week study period.	Safety outcome.	During the 7-week study period.
Plasma concentration of HRS-9821 after 1, 14 and 28 days of treatment.	Pharmacokinetic outcome.	After 1, 14 and 28 days of treatment.
Peak concentration after 1, 14 and 28 days of treatment.	Pharmacokinetic outcome.	After 1, 14 and 28 days of treatment.
Trough concentration after 1, 14 and 28 days of treatment.	Pharmacokinetic outcome.	After 1, 14 and 28 days of treatment.
Population Typical Clearance (CL/F) after 1, 14 and 28 days of treatment.	Pharmacokinetic outcome, population pharmacokinetic (PopPK) parameters.	After 1, 14 and 28 days of treatment.
Population Typical Apparent Volume of Distribution (Vd/F) after 1, 14 and 28 days of treatment.	Pharmacokinetic outcome, population pharmacokinetic (PopPK) parameters.	After 1, 14 and 28 days of treatment.
Changes in maximum mid-expiratory flow (MMEF) after 1, 14 and 28 days of treatment.	Exploratory outcome.	During 28 days of treatment.
Incidence of moderate/severe acute exacerbation of COPD (AECOPD) during 4 weeks of treatment.	Exploratory outcome.	During 4 weeks of treatment.
Changes in peripheral blood biomarkers (EOS, Neut, IL-6, IL-8, CRP, etc.) during 4 weeks of treatment.	Exploratory outcome.	During 4 weeks of treatment.

Collaborators and Investigators

• Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: June 1, 2026
• First Submitted That Met QC Criteria: June 5, 2026
• First Posted (Actual): June 10, 2026

Study Record Updates

• Last Update Posted (Actual): June 10, 2026
• Last Update Submitted That Met QC Criteria: June 5, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pathological Conditions, Signs and Symptoms; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: HRS-9821-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No