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

June 5, 2026 updated by: Guangdong Hengrui Pharmaceutical Co., Ltd

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200065
        • Shanghai Tongji Hospital
        • Contact:
        • Principal Investigator:
          • Jinfu Xu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Changes in peak FEV1 (forced expiratory volume in one second) after 28 days of treatment.
Time Frame: From baseline to 28 days after treatment.
From baseline to 28 days after treatment.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.
Time Frame: During 28 days of treatment.
During 28 days of treatment.
Changes in peak FEV1 after 1 and 14 days of treatment.
Time Frame: 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.
Time Frame: 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.
Time Frame: 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.
Time Frame: During 28 days of treatment.
During 28 days of treatment.
The use of SABA (Short-Acting Beta₂ Agonist) during 28 days of treatment.
Time Frame: During 28 days of treatment.
During 28 days of treatment.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence and severity of adverse events (AEs) during the 7-week study period.
Time Frame: 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.
Time Frame: 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.
Time Frame: 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.
Time Frame: 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.
Time Frame: 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.
Time Frame: 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.
Time Frame: During 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.
Time Frame: 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.
Time Frame: During 4 weeks of treatment.
Exploratory outcome.
During 4 weeks of treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Guangdong Hengrui Pharmaceutical Co., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 1, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 10, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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