COPDPhase 1NCT07116915
A Phase I Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics for a Single Dose of HRS-9821 Powder for Inhalation and Inhalation Suspension Administered in Healthy Subjects and Multiple Doses in Patients With COPD.
A Phase 1 study testing HRS-9821 Powder for Inhalation/HRS-9821 inhalation suspension and Moxifloxacin Hydrochloride Tablets in people with COPD, run by Guangdong Hengrui Pharmaceutical Co., Ltd at 1 site in China.
Trial summary
The aim of this study was to evaluate the safety and tolerability of HRS-9821 Powder for Inhalation and inhalation suspension administered in a single dose in healthy individuals and multiple doses in patients with COPD Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- COPD
- What is being tested?
- HRS-9821 Powder for Inhalation/HRS-9821 inhalation suspension and Moxifloxacin Hydrochloride Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 85 participants
- Where
- 1 siteChina
- Study dates
- 11 Aug 2025to 14 Aug 2026
- 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
- Informed consent was obtained to participate in the trial
- Body weight ≥45 kg, BMI 18-33 kg/m2 (both ends included)
- The 12-lead ECG was normal or abnormal but clinically insignificant until randomization
- Contraception was strict from the time informed consent was signed until 1 month (for subjects receiving HRS-9821/ placebo) or 3 months (for male subjects receiving moxifloxacin) after the last dose
- All study regulations and procedures were followed and inhalation devices used in the study were used correctly during the study
- The following inclusion criteria apply only to healthy subjects:
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- Vital signs were normal at screening
- Pulmonary function was normal during screening
- No smoking or smoking cessation ≥12 months before screening, and previous smoking history <5 pack-years；
- Healthy male 18-50 years old The following inclusion criteria apply only to subjects with COPD
- Male or female, aged 40-75 years;
- Patients diagnosed with COPD;
- A post-bronchodilator FEV1 /FVC < 0.7,40% ≤FEV1 < 80% of the predicted value,;
- Smoking history of≥ 10 pack-years;
- Normal chest X-ray examination results at screening;
- Supporting discontinuation of COPD-related medications before randomization；
Who cannot join
- Mean QTcF ≥ 450 ms at screening；
- Persons who had donated blood or had massive blood loss (> 400 ml) within 4 weeks before screening or who were interested in donating blood during the study
- Receipt of the investigational drug or device within 4 weeks before randomization or less than 5 times the half-life of the drug, whichever was greater;
- Patients who had difficulty in blood collection or could not tolerate venipuncture in the past, such as dizzy with needles or blood
- History of malignancy in any organ system
- Known allergies to salbutamol, study medication, or any excipients in the formulation
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- Known previous infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV); Or positive HIV (according to a trial-site SOP), treponema pallidum antibody, HBV surface antigen, or HCV antibody before randomization
- History of alcohol abuse
- History of drug abuse and drug dependence in the past 5 years；
- Positive for alcohol or substance abuse test before randomization
- During the study, surgery or treatment that might interfere with the conduct of the study was planned；
- Unable or unwilling to fully adhere to the study protocol
- Mentally or legally incapacitated
- There were any other reasons for the subject not to participate in the study in the opinion of the investigator;
- Use of a strong/moderate potency drug that inhibits or induces the hepatic drug-metabolizing enzyme CYP3A4 14 days before the first dose;
- Drugs with effects on P-glycoprotein (P-gp) or breast cancer resistance protein (BCRP) were anticipated to be used during the study;
- History of using HRS-9821 suspension;
- The following exclusion criteria apply only to healthy subjects:
- Have been treated with antibiotics for upper and lower respiratory tract infections within 12 weeks prior to screening;
- Abnormal laboratory or physical examination results with clinical significance;
- Positive urine nicotine test before randomization;
- Have consumed a prescription within 14 days prior to the first dose or over-the-counter drugs within 48 h prior to the first dose; The following exclusion criteria apply only to subjects with COPD
- History of life-threatening acute exacerbation of COPD (AECOPD), including admission to intensive care unit and/or need for invasive ventilator support;
- Diagnosed with other respiratory disorders;
- Pulmonary heart disease, or pulmonary hypertension caused by lung disease and/or hypoxia;
- History of lung volume reduction surgery, partial lung resection, lung transplantation, and other surgeries that may affect pulmonary function results;
- History of AECOPD requiring systemic glucocorticoids or antibiotics or hospitalization within 4 weeks prior to screening;
- Lower respiratory tract infection requiring antibiotic treatment within 4 weeks prior to screening;
- Requiring oxygen therapy or home non-invasive ventilation;
- Currently using or plan to use non-selective beta blockers or other drugs with bronchoconstrictive effects during the study;
- Patients with serious trauma or major surgery within 6 months prior to screening who are still in the recovery period;
- Abnormal laboratory tests at screening and baseline.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study was to evaluate the safety and tolerability of HRS-9821 Powder for Inhalation and inhalation suspension administered in a single dose in healthy individuals and multiple doses in patients with COPD
- Conditions
- COPD
- Being tested
- HRS-9821 Powder for Inhalation/HRS-9821 inhalation suspension, HRS-9821 Powder for Inhalation placebo/HRS-9821 inhalation suspension placebo, Moxifloxacin Hydrochloride Tablets
- 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 Powder for Inhalation/HRS-9821 inhalation suspensionDrug
HRS-9821 Powder for Inhalation. HRS-9821 inhalation suspension
HRS-9821 Powder for Inhalation placebo/HRS-9821 inhalation suspension placeboDrug
HRS-9821 Powder for Inhalation placebo. HRS-9821 inhalation suspension placebo
Moxifloxacin Hydrochloride TabletsDrug
Moxifloxacin Hydrochloride Tablets
| Study group | Role | What they receive |
|---|---|---|
| HRS-9821 Powder for Inhalation or HRS-9821 inhalation suspension | Experimental | Participants inhaled HRS-9821 powder either as a single dose or for 12 days. Receives: Drug: HRS-9821 Powder for Inhalation/HRS-9821 inhalation suspension |
| HRS-9821 Powder for Inhalation placebo or or HRS-9821 inhalation suspension placebo | Placebo comparator | Participants received a single dose or 12 consecutive days of inhaled powdered placebo with HRS-9821. Receives: Drug: HRS-9821 Powder for Inhalation placebo/HRS-9821 inhalation suspension placebo |
| Moxifloxacin | Active comparator | Moxifloxacin is oral Receives: Drug: Moxifloxacin Hydrochloride Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the rate of adverse events
Measured: The screening period lasted until 40 days after administration
Secondary outcomes (5)
Plasma drug concentration after administration
Measured: The screening period lasted until 40 days after administration
Changes in heart rate from baseline after a single dose of HRS-9821 aerosol inhalation in healthy subjects。
Measured: The screening period lasted until 29 days after administration
Changes in QT interval from baseline after a single dose of HRS-9821 aerosol inhalation in healthy subjects.
Measured: The screening period lasted until 29 days after administration
Lung epithelial lining fluid (ELF) drug concentrations based on alveolar lavage (BAL) measurements in healthy subjects after a single dose of HRS-9821 aerosol inhalation
Measured: The screening period lasted until 29 days after administration
Theoretical intracellular drug concentrations based on alveolar lavage fluid (BALF) cells measured by alveolar lavage (BAL) after a single dose of HRS-9821 aerosol inhalation in healthy subjects.
Measured: The screening period lasted until 29 days after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2025
- Study start11 Aug 2025
- Primary completion14 Aug 2026
- Study completion14 Aug 2026
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 85 participants (actual)
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
- NCT07116915
- Sponsor's protocol ID
- HRS-9821-I-102
- Status last verified
- Sep 2026
- First submitted
- 22 Jul 2025
- Last updated
- 9 Sep 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 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics for a Single Dose of HRS-9821 Powder for Inhalation and Inhalation Suspension Administered in Healthy Subjects and Multiple Doses in Patients With COPD.
- ClinicalTrials.gov ID
- NCT07116915
- Acronym / sponsor ID
- HRS-9821-I-102
- Conditions
- COPD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Guangdong Hengrui Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 11 Aug 2025 (actual)
- Primary completion
- 14 Aug 2026 (actual)
- Study completion
- 14 Aug 2026 (actual)
- First posted
- 12 Aug 2025 (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 aim of this study was to evaluate the safety and tolerability of HRS-9821 Powder for Inhalation and inhalation suspension administered in a single dose in healthy individuals and multiple doses in 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
- 3
| Arm | Type | Receives |
|---|---|---|
| HRS-9821 Powder for Inhalation or HRS-9821 inhalation suspension | Experimental | Drug: HRS-9821 Powder for Inhalation/HRS-9821 inhalation suspensionParticipants inhaled HRS-9821 powder either as a single dose or for 12 days. |
| HRS-9821 Powder for Inhalation placebo or or HRS-9821 inhalation suspension placebo | Placebo comparator | Drug: HRS-9821 Powder for Inhalation placebo/HRS-9821 inhalation suspension placeboParticipants received a single dose or 12 consecutive days of inhaled powdered placebo with HRS-9821. |
| Moxifloxacin | Active comparator | Drug: Moxifloxacin Hydrochloride TabletsMoxifloxacin is oral |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Informed consent was obtained to participate in the trial
- Body weight ≥45 kg, BMI 18-33 kg/m2 (both ends included)
- The 12-lead ECG was normal or abnormal but clinically insignificant until randomization
- Contraception was strict from the time informed consent was signed until 1 month (for subjects receiving HRS-9821/ placebo) or 3 months (for male subjects receiving moxifloxacin) after the last dose
- All study regulations and procedures were followed and inhalation devices used in the study were used correctly during the study
Key exclusion criteria (32 listed)
- Mean QTcF ≥ 450 ms at screening；
- Persons who had donated blood or had massive blood loss (> 400 ml) within 4 weeks before screening or who were interested in donating blood during the study
- Receipt of the investigational drug or device within 4 weeks before randomization or less than 5 times the half-life of the drug, whichever was greater;
- Patients who had difficulty in blood collection or could not tolerate venipuncture in the past, such as dizzy with needles or blood
- History of malignancy in any organ system
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 Powder for Inhalation/HRS-9821 inhalation suspensionHRS-9821 Powder for Inhalation. HRS-9821 inhalation suspension | Drug | HRS-9821 Powder for Inhalation or HRS-9821 inhalation suspension |
| HRS-9821 Powder for Inhalation placebo/HRS-9821 inhalation suspension placeboHRS-9821 Powder for Inhalation placebo. HRS-9821 inhalation suspension placebo | Drug | HRS-9821 Powder for Inhalation placebo or or HRS-9821 inhalation suspension placebo |
| Moxifloxacin Hydrochloride TabletsMoxifloxacin Hydrochloride Tablets | Drug | Moxifloxacin |
Primary outcome
Change from baseline in the rate of adverse events
Time frame: The screening period lasted until 40 days after administration
5 secondary outcomes
Plasma drug concentration after administration
Time frame: The screening period lasted until 40 days after administration
Changes in heart rate from baseline after a single dose of HRS-9821 aerosol inhalation in healthy subjects。
Time frame: The screening period lasted until 29 days after administration
Changes in QT interval from baseline after a single dose of HRS-9821 aerosol inhalation in healthy subjects.
Time frame: The screening period lasted until 29 days after administration
Lung epithelial lining fluid (ELF) drug concentrations based on alveolar lavage (BAL) measurements in healthy subjects after a single dose of HRS-9821 aerosol inhalation
Time frame: The screening period lasted until 29 days after administration
Theoretical intracellular drug concentrations based on alveolar lavage fluid (BALF) cells measured by alveolar lavage (BAL) after a single dose of HRS-9821 aerosol inhalation in healthy subjects.
Time frame: The screening period lasted until 29 days after administration
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 9 Sep 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. 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 Powder for Inhalation/HRS-9821 inhalation suspension and Moxifloxacin Hydrochloride Tablets 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 16 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: finished, as of the sponsor's last update on 9 Sep 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 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?
Change from baseline in the rate of adverse events (time frame: The screening period lasted until 40 days after administration). 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 9 Sep 2026; AzTrials last refreshed its copy on 7 Nov 2026.