A Phase I Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HRS-9821 Powder for Inhalation Administered as a Single Dose in Healthy Participants and Multiple Doses in Patients With COPD

The aim of this study was to evaluate the safety and tolerability of HRS-9821 Powder for Inhalation administered in a single dose in healthy individuals and multiple doses in patients with COPD。

Study Overview

• Status: Recruiting
• Conditions: COPD
• Intervention / Treatment: Drug: HRS-9821 Powder for Inhalation; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Liping Liu; Phone Number: +86 18217192573; Email: Liping.liu.ll5@hengrui.com

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610044
      • Recruiting
      • West China Hospital, Sichuan University
      • Principal Investigator: Zhu Luo
      • Principal Investigator: Wei min Li

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Informed consent was obtained to participate in the trial
2. Body weight ≥45 kg,and BMI 18-33 kg/m2 (both ends included)
3. The 12-lead ECG was normal or abnormal but clinically insignificant until randomization
4. 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

5. 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:

6. Vital signs were normal at screening
7. Pulmonary function was normal during screening
8. No smoking or smoking cessation ≥12 months before screening, and previous smoking history <5 pack-years；

9. Healthy male 18-50 years old

   The following inclusion criteria apply only to subjects with COPD

10. Male or female, aged 40-75 years;
11. Patients diagnosed with COPD;
12. A post-bronchodilator FEV1 /FVC < 0.7,40% ≤FEV1 < 80% of the predicted value,;
13. Smoking history of≥ 10 pack-years;
14. Normal chest X-ray examination results at screening;
15. Supporting discontinuation of COPD-related medications before randomization；

Exclusion Criteria:

1. Mean QTcF ≥ 450 ms at screening；
2. 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
3. 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;
4. Patients who had difficulty in blood collection or could not tolerate venipuncture in the past, such as dizzy with needles or blood
5. History of malignancy in any organ system
6. Known allergies to salbutamol, study medication, or any excipients in the formulation
7. 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
8. History of alcohol abuse
9. History of drug abuse and drug dependence in the past 5 years；
10. Positive for alcohol or substance abuse test before randomization
11. During the study, surgery or treatment that might interfere with the conduct of the study was planned；
12. Unable or unwilling to fully adhere to the study protocol
13. Mentally or legally incapacitated
14. There were any other reasons for the subject not to participate in the study in the opinion of the investigator;
15. Use of a strong/moderate potency drug that inhibits or induces the hepatic drug-metabolizing enzyme CYP3A4 14 days before the first dose;
16. Drugs with effects on P-glycoprotein (P-gp) or breast cancer resistance protein (BCRP) were anticipated to be used during the study;

17. History of using HRS-9821 suspension;

    The following exclusion criteria apply only to healthy subjects:

18. Have been treated with antibiotics for upper and lower respiratory tract infections within 12 weeks prior to screening;
19. Abnormal laboratory or physical examination results with clinical significance;
20. Positive urine nicotine test before randomization;
21. 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 22. History of life-threatening acute exacerbation of COPD (AECOPD), including admission to intensive care unit and/or need for invasive ventilator support; 23. Diagnosed with other respiratory disorders; 24. Pulmonary heart disease, or pulmonary hypertension caused by lung disease and/or hypoxia; 25. History of lung volume reduction surgery, partial lung resection, lung transplantation, and other surgeries that may affect pulmonary function results; 26. History of AECOPD requiring systemic glucocorticoids or antibiotics or hospitalization within 4 weeks prior to screening; 27. Lower respiratory tract infection requiring antibiotic treatment within 4 weeks prior to screening; 28. Requiring oxygen therapy or home non-invasive ventilation; 29. Currently using or plan to use non-selective beta blockers or other drugs with bronchoconstrictive effects during the study; 30. Patients with serious trauma or major surgery within 6 months prior to screening who are still in the recovery period; 31. Abnormal laboratory tests at screening and baseline.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HRS-9821 Powder for Inhalation; Participants inhaled HRS-9821 powder either as a single dose or for 12 days.	Drug: HRS-9821 Powder for Inhalation; HRS-9821 Powder for Inhalation
Placebo Comparator: placebo for HRS-9821 Powder Inhalation; Participants received a single dose or 12 consecutive days of placebo for HRS-9821 Powder Inhalation with HRS-9821.	Drug: Placebo; placebo for HRS-9821 Powder Inhalation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in the rate of adverse events	The screening period lasted until 26days after administration

Secondary Outcome Measures

Outcome Measure	Time Frame
Plasma drug concentration after administration	The screening period lasted until 21 days after administration

Collaborators and Investigators

• Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): July 9, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: April 28, 2026
• First Submitted That Met QC Criteria: April 28, 2026
• First Posted (Actual): May 5, 2026

Study Record Updates

• Last Update Posted (Actual): July 20, 2026
• Last Update Submitted That Met QC Criteria: July 17, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pathological Conditions, Signs and Symptoms; Pulmonary Disease, Chronic Obstructive; Circulatory and Respiratory Physiological Phenomena; Respiratory Mechanics; Respiration; Respiratory Physiological Phenomena; Inhalation
• Other Study ID Numbers: HRS-9821-I-103

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