COPDPhase 2NCT07640451
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 study testing HRS-9821 Inhalation Suspension in people with COPD, run by Guangdong Hengrui Pharmaceutical Co., Ltd at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- COPD
- What is being tested?
- HRS-9821 Inhalation Suspension
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 20 Jul 2026to Nov 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%.
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- 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.
Who cannot join
- 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.
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- 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.
- Non-selective β blockers within 1 week.
- Overly potent/moderately potent drugs that inhibit or induce the liver drug-metabolizing enzyme CYP3A4 within 14 days.
- Allergic to the research drug or salbutamol or excipients.
- Has been used HRS-9821.
- Drug abuse and alcohol abuse within 1 year.
- Pregnant or lactating period or planning to be pregnant or lactating.
- The researchers judged that there were other unsuitable circumstances.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Tongji Hospital
Shanghai, Shanghai Municipality, 200065
Jinfu Xu, +86-13321922898, jfxucn@163.com
Jinfu Xu
About this study
Official title: 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.
- Conditions
- COPD
- Being tested
- HRS-9821 Inhalation Suspension, HRS-9821 Placebo Inhalation Suspension
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-9821 Inhalation SuspensionDrug
HRS-9821 Inhalation Suspension.
HRS-9821 Placebo Inhalation SuspensionDrug
HRS-9821 Placebo Inhalation Suspension.
| Study group | Role | What they receive |
|---|---|---|
| HRS-9821 Group - Dose 1 | Experimental | HRS-9821 Inhalation Suspension, Dose 1. Receives: Drug: HRS-9821 Inhalation Suspension |
| HRS-9821 Group - Dose 2 | Experimental | HRS-9821 Inhalation Suspension, Dose 2. Receives: Drug: HRS-9821 Inhalation Suspension |
| HRS-9821 Placebo Group - Dose 1 | Placebo comparator | HRS-9821 Placebo Inhalation Suspension, Dose 1. Receives: Drug: HRS-9821 Placebo Inhalation Suspension |
| HRS-9821 Placebo Group - Dose 2 | Placebo comparator | HRS-9821 Placebo Inhalation Suspension, Dose 2. Receives: Drug: HRS-9821 Placebo Inhalation Suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in peak FEV1 (forced expiratory volume in one second) after 28 days of treatment.
Measured: From baseline to 28 days after treatment.
Secondary outcomes (6)
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.
Measured: During 28 days of treatment.
Changes in peak FEV1 after 1 and 14 days of treatment.
Measured: After 1 and 14 days of treatment.
Changes in trough FEV1 after 1, 14 and 28 days of treatment.
Measured: After 1, 14 and 28 days of treatment.
Changes in FVC (forced vital capacity) during 28 days of treatment.
Measured: 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.
Measured: During 28 days of treatment.
The use of SABA (Short-Acting Beta₂ Agonist) during 28 days of treatment.
Measured: During 28 days of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study start20 Jul 2026
- Primary completionOct 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by Guangdong Hengrui Pharmaceutical Co., LtdThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- HRS-9821 inhalation suspension compared with placebo.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Hengrui Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07640451
- Sponsor's protocol ID
- HRS-9821-201
- Status last verified
- Jun 2026
- First submitted
- 1 Jun 2026
- Last updated
- 18 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07640451
- Acronym / sponsor ID
- HRS-9821-201
- Conditions
- COPD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Guangdong Hengrui Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 20 Jul 2026 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 10 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- HRS-9821 inhalation suspension compared with placebo.
| Arm | Type | Receives |
|---|---|---|
| HRS-9821 Group - Dose 1 | Experimental | Drug: HRS-9821 Inhalation SuspensionHRS-9821 Inhalation Suspension, Dose 1. |
| HRS-9821 Group - Dose 2 | Experimental | Drug: HRS-9821 Inhalation SuspensionHRS-9821 Inhalation Suspension, Dose 2. |
| HRS-9821 Placebo Group - Dose 1 | Placebo comparator | Drug: HRS-9821 Placebo Inhalation SuspensionHRS-9821 Placebo Inhalation Suspension, Dose 1. |
| HRS-9821 Placebo Group - Dose 2 | Placebo comparator | Drug: HRS-9821 Placebo Inhalation SuspensionHRS-9821 Placebo Inhalation Suspension, Dose 2. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (32 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HRS-9821 Inhalation SuspensionHRS-9821 Inhalation Suspension. | Drug | HRS-9821 Group - Dose 1, HRS-9821 Group - Dose 2 |
| HRS-9821 Placebo Inhalation SuspensionHRS-9821 Placebo Inhalation Suspension. | Drug | HRS-9821 Placebo Group - Dose 1, HRS-9821 Placebo Group - Dose 2 |
Primary outcome
Changes in peak FEV1 (forced expiratory volume in one second) after 28 days of treatment.
Time frame: From baseline to 28 days after treatment.
6 secondary outcomes
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.
Changes in peak FEV1 after 1 and 14 days of treatment.
Time frame: 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.
Changes in FVC (forced vital capacity) during 28 days of treatment.
Time frame: 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.
The use of SABA (Short-Acting Beta₂ Agonist) during 28 days of treatment.
Time frame: During 28 days of treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HRS-9821 Inhalation Suspension in people with COPD, run by Guangdong Hengrui Pharmaceutical Co., Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Si Chen, M.M (+86-0518-82342973, si.chen.sc96@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in peak FEV1 (forced expiratory volume in one second) after 28 days of treatment. (time frame: From baseline to 28 days after treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026; AzTrials last refreshed its copy on 7 Nov 2026.