Groups 1, 3, 4, 5 and 6 of this research team adopted a single-center, open-label design. Group 2 used a three-sequence, three-period crossover design, where participants in this dose group were randomly assigned to the three sequences in a 1:1:1 ratio to undergo three-period crossover administration. Healthy adult subjects were selected to use TQC3302 inhalation spray to evaluate the safety, tolerability, and pharmacokinetic characteristics of single and multiple inhalations of TQC3302 inhalation spray in healthy participants.
Subjects voluntarily joined the study, sign informed consent form before the study and fully understand the study content
Healthy subjects aged between 18 and 55 years (inclusive),both male and female
The male subject should weigh at least 50kg, the female subject should weigh at least 45kg. And body mass index (BMI) within 19~28 kg/m2
Inhalation administration training qualified.
Individuals with a history of glaucoma, functional constipation, benign prostatic hyperplasia, urinary tract obstruction, etc
Current history of active tuberculosis, bronchiectasis or other non-specific lung diseases
People who have received or are planning to receive inactive or active vaccines during the 30 days prior to the screening period and the entire study period
Any history of drug allergies, Individuals with a specific history of allergies or allergies
Crossover
TQC3302 inhalation spray
DrugTQC3302 inhalation spray is a targeted inhibitor
TQC3302 inhalation spray+Tiotropium bromide and olodaterol hydrochloride inhalation spray +Budesonide Powder for Inhalation
DrugTQC3302 inhalation spray is a targeted inhibitor, Tiotropium bromide and olodaterol hydrochloride inhalation spray is a targeted inhibitor, Budesonide Powder for Inhalation is a Inhaled Corticosteroids.
Tiotropium bromide and olodaterol hydrochloride inhalation spray +Budesonide Powder for Inhalation+ TQC3302 inhalation spray
DrugTQC3302 inhalation spray is a targeted inhibitor, Tiotropium bromide and olodaterol hydrochloride inhalation spray is a targeted inhibitor, Budesonide Powder for Inhalation is a Inhaled Corticosteroids.
Budesonide Powder for Inhalation+ TQC3302 inhalation spray+ Tiotropium bromide and olodaterol hydrochloride inhalation spray
DrugTQC3302 inhalation spray is a targeted inhibitor, Tiotropium bromide and olodaterol hydrochloride inhalation spray is a targeted inhibitor, Budesonide Powder for Inhalation is a Inhaled Corticosteroids.
TQC3302 inhalation spray
DrugTQC3302 inhalation spray is a targeted inhibitor
9
Treatment groupsSee each treatment group below.
Treatment Emergent Adverse Event
The incidence and severity of adverse events after treatment From the use of the investigational drug until the last study visit.
The subject with abnormal security check
The frequency, incidence, and severity of laboratory tests, vital signs, physical examinations, electrocardiogram examinations, etc.
Cmax after dose
The Cmax is the maximum observed plasma concentration of study drug
Area Under the Concentration-Time Curve From 0 to Last Observation (AUC [0-t])
To characterize the pharmacokinetics of TQC3302 by assessment of area under the plasma concentration time curve from the first dose to a certain time point
Area Under the Concentration-Time Curve From Zero to Infinity (AUC [0-infinity])
To characterize the pharmacokinetics of TQC3302 by assessment of area under the plasma concentration time curve from 0 extrapolated to infinity.
Time to reach maximum (peak) plasma concentration following drug administration (Tmax)
To characterize the pharmacokinetics of TQC3302 by assessment of time to reach maximum plasma concentration after single dosing.
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