Chronic Obstructive Pulmonary DiseasePhase 1NCT05622864

Study on Single and Multiple Atomization Inhalation of HRS-9821 Suspension for Inhalation in Healthy Subjects and COPD Patients

A Phase 1 study testing HRS-9821 in people with Chronic Obstructive Pulmonary Disease, run by Guangdong Hengrui Pharmaceutical Co., Ltd at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The increased safety and tolerance of single and multiple atomized inhalation of HRS-9821 suspension for inhalation doses in healthy subjects and COPD patients. Read more about this study

Who is it for?: Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Chronic Obstructive Pulmonary Disease
What is being tested?: HRS-9821
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 106 participants
Where: 1 siteChina
Study dates: 12 Jan 2023to 16 Jun 2025
Phase: Phase 1
Are there results?: None posted in the registry

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 18 to 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Sign an informed consent forms；
Healthy men aged 18-50 (both ends, subject to the signing of the informed consent form); COPD patients aged 40-75 (both ends, subject to the signing of the informed consent form);
Weight ≥45 kg，BMI 18-33 kg/m2 (include 33 kg/m2);
During the screening period, the vital signs of healthy subjects are normal:
Shrinkage 90-140 mmHg,
diastolic pressure 50-90 mmHg,

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Heart rate 40-100 times/min;
During the screening period, the lung function of healthy subjects is normal, that is, the predicted value of FEV1≥80% and the predicted value of FEV1/FVC≥92%; After COPD patients inhale bronchodilators, he predicted value of FEV1≥40% and the predicted value of FEV1/FVC<0.7;
During screening, the 12-lead ECG is normal or abnormal but has no clinical significance.
Follow the contraceptive requirements within 14 weeks from the beginning of the consent to the last dose, and do not donate sperm during the consent period;
During the study, all research regulations and procedures can be followed, and the atomization devices used by the research institute can be used correctly;
Healthy subjects: non-smoking or quitting smoking ≥ 12 months, the previous smoking history < 5 packs of years; COPD patients: the previous smoking history ≥ 10 packs of years.

Who cannot join

Healthy subjects: in the past 12 weeks, antibiotics have been used for upper and lower respiratory tract infections, or have a history of respiratory infections within the past 4 weeks; COPD patients: in the past 4 weeks, antibiotics have been used for lower respiratory tract infections;
Healthy subjects: abnormal laboratory or physical examination results of clinical significance;
The average value of QTcF for 3 times at screening is ≥450ms;
In the past four weeks, there have been blood donations or large blood loss (more than 400 milliliters), or those who intentionally donate blood during the study;
Accept experimental drugs or use experimental medical devices within 1 months or less than 5 times the half-life of the drug, whichever is longer;
In the past, there were difficulties in collecting blood or could not withstand intravenous puncture, such as needle halo and blood halo

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Any organ system has a history of malignant tumors;
Known to be allergic to any accessories in the research drug or formulation;
Previously known infection of human immunodeficiency virus (HIV), hepatitis B virus (HBV) liver or hepatitis C virus (HCV); or randomized pre-HIV (according to the test center SOP), treponema pallidum antibody (TPPA), HBV surface antigen or HCV antibody positive;
There is a history of smoking and alcoholism in the 3 months before screening: smoking (more than 5 cigarettes or equivalent tobacco per day); alcoholism (more than 14 units of alcohol per week: 1 unit = 360 mL of beer, or 25 mL of spirits with a concentration of 40% or more, or 1 glass of wine, 180mL);
In the past five years, there has been a history of drug abuse and drug dependence;
Before randomization, positive for alcohol or drug abuse or nicotine in urine;
During the study, there is a surgical plan or may interfere with the treatment plan carried out by the study;
Inability or unwillingness to fully comply with the research program;
Mentally or legally incapacitated;
The researchers believe that there are any other reasons why the subjects are unfit to participate in the study;
Prescription was used within 14 days before the first administration or within 48 hours before the first administration;
Drugs that have used strong/intermediate inhibitors or induce liver drug metabolic enzyme CYP3A4 14 days before the first administration or ingest grapefruit or related products within 7 days before the first administration;
During the study, it was expected to use drugs that had an effect on P-gp or breast cancer drug-resistant protein (BCRP).

Trial locations and contacts

1 site in 1 country.

China1 site

West China Hospital，Sichuan University
Chengdu, Sichuan, 610044

Other trials in China

About this study

Official title: Phase I Study on the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Dose Escalation of Nebulized Inhalation of HRS-9821 Suspension in Healthy Individuals and Multiple Doses in COPD Patients

The increased safety and tolerance of single and multiple atomized inhalation of HRS-9821 suspension for inhalation doses in healthy subjects and COPD patients.

Conditions: Chronic Obstructive Pulmonary Disease
Being tested: HRS-9821
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-9821Drug
HRS-9821
HRS-9821Drug
HRS-9821

Study groups in NCT05622864
Study group	Role	What they receive
Part A	Experimental	Not described Receives: Drug: HRS-9821
Part B	Experimental	Not described Receives: Drug: HRS-9821

What is being measured

The primary outcome is the main question the study is designed to answer.

Assess the incidence and severity of adverse events after single atomization inhalation of HRS-9821 in healthy subjects and multiple atomization inhalation of HRS-9821 in COPD patients.
Measured: About a month from the first medication to the evaluation.

Secondary outcomes (13)

Evaluate the forced expiratory volume in one second (FEV1) after single atomization inhalation of HRS-9821 in healthy subjects and multiple atomization inhalation of HRS-9821 in COPD patients.
Measured: 2 hours after the first dose
Evaluate the forced expiratory volume in one second (FEV1) after single atomization inhalation of HRS-9821 in healthy subjects and multiple atomization inhalation of HRS-9821 in COPD patients.
Measured: 4 hours after the first dose
Evaluate the forced expiratory volume in one second (FEV1) after single atomization inhalation of HRS-9821 in healthy subjects and multiple atomization inhalation of HRS-9821 in COPD patients.
Measured: 6 hours after the first dose
Evaluate the forced expiratory volume in one second (FEV1) after single atomization inhalation of HRS-9821 in healthy subjects and multiple atomization inhalation of HRS-9821 in COPD patients.
Measured: 12 hours after the first dose
Evaluate the forced expiratory volume in one second (FEV1) after single atomization inhalation of HRS-9821 in healthy subjects and multiple atomization inhalation of HRS-9821 in COPD patients.
Measured: 24 hours after the first dose
Evaluate the average value of FEV1 compared with baseline changes after single atomization inhalation of HRS-9821 in healthy subjects and multiple atomization inhalation of HRS-9821 in COPD patients.
Measured: 2 hours after the first dose
Evaluate the average value of FEV1 compared with baseline changes after single atomization inhalation of HRS-9821 in healthy subjects and multiple atomization inhalation of HRS-9821 in COPD patients.
Measured: 3 hours after the first dose
Evaluate the average value of FEV1 compared with baseline changes after single atomization inhalation of HRS-9821 in healthy subjects and multiple atomization inhalation of HRS-9821 in COPD patients.
Measured: 4 hours after the first dose
Evaluate the average value of FEV1 compared with baseline changes after single atomization inhalation of HRS-9821 in healthy subjects and multiple atomization inhalation of HRS-9821 in COPD patients.
Measured: 12 hours after the first dose
Evaluate the average value of FEV1 compared with baseline changes after single atomization inhalation of HRS-9821 in healthy subjects and multiple atomization inhalation of HRS-9821 in COPD patients.
Measured: 24 hours after the first dose
Evaluate the change of FEV1 peak after single atomization inhalation of HRS-9821 in healthy subjects and multiple atomization inhalation of HRS-9821 in COPD patients.
Measured: About 24 hours after the first dose
Evaluate the force lung capacity (FVC) after single atomization inhalation of HRS-9821 in healthy subjects and multiple atomization inhalation of HRS-9821 in COPD patients.
Measured: 2 hours after the first dose
Evaluate pharmacokinetics concentration and pharmacokinetic parameters of after single atomization inhalation of HRS-9821 in healthy subjects and multiple atomization inhalation of HRS-9821 in COPD patients.
Measured: 2 weeks after the first dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Jan 202316 Jun 2025

First posted21 Nov 2022
Study start12 Jan 2023
Primary completion7 May 2025
Study completion16 Jun 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 106 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05622864
Sponsor's protocol ID: HRS-9821-I-101
Status last verified: Jul 2025
First submitted: 14 Nov 2022
Last updated: 24 Jul 2025
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitationObservational study
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Anosmia, Chronic Obstructive Pulmonary Disease
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A Study to Evaluate Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease
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Chronic Obstructive Pulmonary Disease, Lung Diseases, Obstructive
Not yet recruitingPhase 3
The AIRWARD Study: A Study to Test Whether Verducatib Helps People With Chronic Obstructive Pulmonary Disease
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Not yet recruiting
Evaluating and Promoting Resilience in Adolescents With Tourette Syndrome
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All Chronic Obstructive Pulmonary Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase I Study on the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Dose Escalation of Nebulized Inhalation of HRS-9821 Suspension in Healthy Individuals and Multiple Doses in COPD Patients
ClinicalTrials.gov ID: NCT05622864
Acronym / sponsor ID: HRS-9821-I-101
Conditions: Chronic Obstructive Pulmonary Disease
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 106 participants (actual)
Lead sponsor: Guangdong Hengrui Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
Study start: 12 Jan 2023 (actual)
Primary completion: 7 May 2025 (actual)
Study completion: 16 Jun 2025 (actual)
First posted: 21 Nov 2022 (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 increased safety and tolerance of single and multiple atomized inhalation of HRS-9821 suspension for inhalation doses in healthy subjects and COPD patients.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Part A	Experimental	Drug: HRS-9821
Part B	Experimental	Drug: HRS-9821

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

Sign an informed consent forms；
Healthy men aged 18-50 (both ends, subject to the signing of the informed consent form); COPD patients aged 40-75 (both ends, subject to the signing of the informed consent form);
Weight ≥45 kg，BMI 18-33 kg/m2 (include 33 kg/m2);
During the screening period, the vital signs of healthy subjects are normal:
During the screening period, the lung function of healthy subjects is normal, that is, the predicted value of FEV1≥80% and the predicted value of FEV1/FVC≥92%; After COPD patients inhale bronchodilators, he predicted value of FEV1≥40% and the predicted value of FEV1/FVC<0.7;

Key exclusion criteria (19 listed)

Healthy subjects: in the past 12 weeks, antibiotics have been used for upper and lower respiratory tract infections, or have a history of respiratory infections within the past 4 weeks; COPD patients: in the past 4 weeks, antibiotics have been used for lower respiratory tract infections;
Healthy subjects: abnormal laboratory or physical examination results of clinical significance;
The average value of QTcF for 3 times at screening is ≥450ms;
In the past four weeks, there have been blood donations or large blood loss (more than 400 milliliters), or those who intentionally donate blood during the study;
Accept experimental drugs or use experimental medical devices within 1 months or less than 5 times the half-life of the drug, whichever is longer;

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-9821HRS-9821	Drug	Part A
HRS-9821HRS-9821	Drug	Part B

Primary outcome

Assess the incidence and severity of adverse events after single atomization inhalation of HRS-9821 in healthy subjects and multiple atomization inhalation of HRS-9821 in COPD patients.
Time frame: About a month from the first medication to the evaluation.

13 secondary outcomes

Evaluate the forced expiratory volume in one second (FEV1) after single atomization inhalation of HRS-9821 in healthy subjects and multiple atomization inhalation of HRS-9821 in COPD patients.
Time frame: 2 hours after the first dose
Evaluate the forced expiratory volume in one second (FEV1) after single atomization inhalation of HRS-9821 in healthy subjects and multiple atomization inhalation of HRS-9821 in COPD patients.
Time frame: 4 hours after the first dose
Evaluate the forced expiratory volume in one second (FEV1) after single atomization inhalation of HRS-9821 in healthy subjects and multiple atomization inhalation of HRS-9821 in COPD patients.
Time frame: 6 hours after the first dose
Evaluate the forced expiratory volume in one second (FEV1) after single atomization inhalation of HRS-9821 in healthy subjects and multiple atomization inhalation of HRS-9821 in COPD patients.
Time frame: 12 hours after the first dose
Evaluate the forced expiratory volume in one second (FEV1) after single atomization inhalation of HRS-9821 in healthy subjects and multiple atomization inhalation of HRS-9821 in COPD patients.
Time frame: 24 hours after the first dose
Evaluate the average value of FEV1 compared with baseline changes after single atomization inhalation of HRS-9821 in healthy subjects and multiple atomization inhalation of HRS-9821 in COPD patients.
Time frame: 2 hours after the first dose
Evaluate the average value of FEV1 compared with baseline changes after single atomization inhalation of HRS-9821 in healthy subjects and multiple atomization inhalation of HRS-9821 in COPD patients.
Time frame: 3 hours after the first dose
Evaluate the average value of FEV1 compared with baseline changes after single atomization inhalation of HRS-9821 in healthy subjects and multiple atomization inhalation of HRS-9821 in COPD patients.
Time frame: 4 hours after the first dose
Evaluate the average value of FEV1 compared with baseline changes after single atomization inhalation of HRS-9821 in healthy subjects and multiple atomization inhalation of HRS-9821 in COPD patients.
Time frame: 12 hours after the first dose
Evaluate the average value of FEV1 compared with baseline changes after single atomization inhalation of HRS-9821 in healthy subjects and multiple atomization inhalation of HRS-9821 in COPD patients.
Time frame: 24 hours after the first dose
Evaluate the change of FEV1 peak after single atomization inhalation of HRS-9821 in healthy subjects and multiple atomization inhalation of HRS-9821 in COPD patients.
Time frame: About 24 hours after the first dose
Evaluate the force lung capacity (FVC) after single atomization inhalation of HRS-9821 in healthy subjects and multiple atomization inhalation of HRS-9821 in COPD patients.
Time frame: 2 hours after the first dose
Evaluate pharmacokinetics concentration and pharmacokinetic parameters of after single atomization inhalation of HRS-9821 in healthy subjects and multiple atomization inhalation of HRS-9821 in COPD patients.
Time frame: 2 weeks after the first dose

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2025.
Individual participant dataSharing planned: Undecided

Related trials for Chronic Obstructive Pulmonary Disease

Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Evaluate Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease
Chronic Graft-versus-host-disease
Not yet recruiting
Impact of Multidisciplinary Care, Structured and Targeted on the COPD Patient's Clinical Pathway.
Chronic Obstructive Pulmonary Disease, Lung Diseases, Obstructive
Not yet recruitingPhase 3
The AIRWARD Study: A Study to Test Whether Verducatib Helps People With Chronic Obstructive Pulmonary Disease
Chronic Obstructive Pulmonary Disease
Not yet recruiting
Evaluating and Promoting Resilience in Adolescents With Tourette Syndrome
Tourette Syndrome, Tic Disorders

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. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing HRS-9821 in people with Chronic Obstructive Pulmonary Disease, 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 12 inclusion and 19 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: finished, as of the sponsor's last update on 24 Jul 2025. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assess the incidence and severity of adverse events after single atomization inhalation of HRS-9821 in healthy subjects and multiple atomization inhalation of HRS-9821 in COPD patients. (time frame: About a month from the first medication to the evaluation.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05622864.

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 24 Jul 2025.