RecruitingPhase 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.

Sponsor

Guangdong Hengrui Pharmaceutical Co., Ltd

Enrollment

160 participants

Start Date

Aug 11, 2025

Study Type

INTERVENTIONAL

Conditions

COPD

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

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria14

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
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；
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 Criteria30

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
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;
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;
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.