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RecruitingNCT07640451Updated Aug 18, 2026

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 Phase 2 interventional study of HRS-9821 Inhalation Suspension and HRS-9821 Placebo Inhalation Suspension in COPD, sponsored by Guangdong Hengrui Pharmaceutical Co., Ltd. Recruiting at 1 site in China. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-08-18.

Sponsored by Guangdong Hengrui Pharmaceutical Co., Ltd · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Jul 2026; still recruiting 2 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
40 Years to 80 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • COPD
03

In context

Pulmonary Disease, Chronic Obstructive

4,131 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 697 are open to participants now.

This study's planned enrollment of 90 is above the median of 70 across 2,926 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.

Browse Pulmonary Disease, Chronic Obstructive studies →

Lead sponsor

Guangdong Hengrui Pharmaceutical Co., Ltd is the lead sponsor of 58 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
90 participants (estimated)

Study arms

  • Experimental
    HRS-9821 Group - Dose 1

    HRS-9821 Inhalation Suspension, Dose 1.

    Drug: HRS-9821 Inhalation Suspension

  • Experimental
    HRS-9821 Group - Dose 2

    HRS-9821 Inhalation Suspension, Dose 2.

    Drug: 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

  • Placebo comparator
    HRS-9821 Placebo Group - Dose 2

    HRS-9821 Placebo Inhalation Suspension, Dose 2.

    Drug: HRS-9821 Placebo Inhalation Suspension

Interventions

  • DrugHRS-9821 Inhalation Suspension

    HRS-9821 Inhalation Suspension.

  • DrugHRS-9821 Placebo Inhalation Suspension

    HRS-9821 Placebo Inhalation Suspension.

06

What researchers measure

Primary outcomes

  1. Changes in peak FEV1 (forced expiratory volume in one second) after 28 days of treatment.

    Time frame: From baseline to 28 days after treatment.

Secondary outcomes

  1. 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.

    Time frame: During 28 days of treatment.

  2. Changes in peak FEV1 after 1 and 14 days of treatment.

    Time frame: After 1 and 14 days of treatment.

  3. Changes in trough FEV1 after 1, 14 and 28 days of treatment.

    Time frame: After 1, 14 and 28 days of treatment.

  4. Changes in FVC (forced vital capacity) during 28 days of treatment.

    Time frame: During 28 days of treatment.

  5. Changes of in SGRQ (St. George's Respiratory Questionnaire), CAT (COPD Assessment Test), mMRC (modified Medical Research Council） score during 28 days of treatment.

    Time frame: During 28 days of treatment.

  6. The use of SABA (Short-Acting Beta₂ Agonist) during 28 days of treatment.

    Time frame: During 28 days of treatment.

Other outcomes

  1. Incidence and severity of adverse events (AEs) during the 7-week study period.

    Safety outcome.

    Time frame: During the 7-week study period.

  2. Plasma concentration of HRS-9821 after 1, 14 and 28 days of treatment.

    Pharmacokinetic outcome.

    Time frame: After 1, 14 and 28 days of treatment.

  3. Peak concentration after 1, 14 and 28 days of treatment.

    Pharmacokinetic outcome.

    Time frame: After 1, 14 and 28 days of treatment.

  4. Trough concentration after 1, 14 and 28 days of treatment.

    Pharmacokinetic outcome.

    Time frame: After 1, 14 and 28 days of treatment.

  5. Population Typical Clearance (CL/F) after 1, 14 and 28 days of treatment.

    Pharmacokinetic outcome, population pharmacokinetic (PopPK) parameters.

    Time frame: After 1, 14 and 28 days of treatment.

  6. Population Typical Apparent Volume of Distribution (Vd/F) after 1, 14 and 28 days of treatment.

    Pharmacokinetic outcome, population pharmacokinetic (PopPK) parameters.

    Time frame: After 1, 14 and 28 days of treatment.

  7. Changes in maximum mid-expiratory flow (MMEF) after 1, 14 and 28 days of treatment.

    Exploratory outcome.

    Time frame: During 28 days of treatment.

  8. Incidence of moderate/severe acute exacerbation of COPD (AECOPD) during 4 weeks of treatment.

    Exploratory outcome.

    Time frame: During 4 weeks of treatment.

  9. Changes in peripheral blood biomarkers (EOS, Neut, IL-6, IL-8, CRP, etc.) during 4 weeks of treatment.

    Exploratory outcome.

    Time frame: During 4 weeks of treatment.

07

Study locations

1 of 1 sites recruiting
  • Shanghai Tongji Hospital
    Shanghai, Shanghai Municipality 200065, China
    • Jinfu Xu · Contact · jfxucn@163.com · +86-13321922898
    • Jinfu Xu · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07640451
Lead sponsor
Guangdong Hengrui Pharmaceutical Co., Ltd
Responsible party
Sponsor
First posted
Jun 10, 2026
Start date
Jul 20, 2026
Primary completion
Oct 2026 (estimated)
Completion
Nov 2026 (estimated)
Last update
Aug 18, 2026

Study contacts

Si Chen, M.M
Contact
si.chen.sc96@hengrui.com
+86-0518-82342973

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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