A Phase I Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HRS-9… (NCT07567872) | Clinical Trial Compass
Not Yet RecruitingPhase 1
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
China48 participantsStarted 2026-06
Plain-language summary
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。
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Informed consent was obtained to participate in the trial
✓. 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；
Exclusion criteria
✕. 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
What they're measuring
1
Change from baseline in the rate of adverse events
Timeframe: The screening period lasted until 26days after administration
✕. 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