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NCT07116915 | RECRUITING | COPD

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

Brief 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

Condition or disease

COPD

Intervention/treatment

HRS-9821 Powder for Inhalation/HRS-9821 inhalation suspension

HRS-9821 Powder for Inhalation placebo/HRS-9821 inhalation suspension placebo

Moxifloxacin Hydrochloride Tablets

Phase

PHASE1

Study Type : INTERVENTIONAL
Estimated Enrollment : 160 participants
Masking : QUADRUPLE
Primary Purpose : TREATMENT
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.
Actual Study Start Date : 2025-08-11
Estimated Primary Completion Date : 2026-12
Estimated Study Completion Date : 2026-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
Inclusion Criteria
  • 1. Informed consent was obtained to participate in the trial
  • 2. Body weight ≥45 kg, 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.
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.

Location Details

NCT07116915

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

China, Sichuan

West China Hospital, Sichuan University

Chengdu, Sichuan, China, 610044