About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- TQC3302 inhalation spray
- TQC3302 inhalation spray+Tiotropium bromide and olodaterol hydrochloride inhalation spray +Budesonide Powder for Inhalation
- Tiotropium bromide and olodaterol hydrochloride inhalation spray +Budesonide Powder for Inhalation+ TQC3302 inhalation spray
- Budesonide Powder for Inhalation+ TQC3302 inhalation spray+ Tiotropium bromide and olodaterol hydrochloride inhalation spray
- TQC3302 inhalation spray
Treatment groups
9
Treatment groupsSee each treatment group below.