Testing the inhaled drug HRS-9821 in healthy people and in people with COPD

Trial details

Who runs it

Guangdong Hengrui Pharmaceutical Co., Ltd

Trial code

NCT07567872

Record updated

20 July 2026

Original description

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。Read full original descriptionShow less

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。

Inclusion: Informed consent was obtained to participate in the trial; Body weight ≥45 kg,and 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:; 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；.

Exclusion: 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; 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; During the study, surgery or treatment that might interfere with the conduct of the study was planned；; Use of a strong/moderate potency drug that inhibits or induces the hepatic drug-metabolizing enzyme CYP3A4 14 days before the first dose; Have been treated with antibiotics for upper and lower respiratory tract infections within 12 weeks prior to screening; History of malignancy in any organ system; Known allergies to salbutamol, study medication, or any excipients in the formulation; History of alcohol abuse; History of drug abuse and drug dependence in the past 5 years；; 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:; Abnormal laboratory or physical examination results with clinical significance; 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; Mean QTcF ≥ 450 ms at screening；; Patients who had difficulty in blood collection or could not tolerate venipuncture in the past, such as dizzy with needles or blood; Positive for alcohol or substance abuse test before randomization; 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; Positive urine nicotine test before randomization.

ClinicalTrials.gov NCT07567872