Phase I Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetic Profile of TQC3302 Inhalation Spray in Healthy Adult Subjects in China
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 55
Healthy Volunteers: t
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• 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.
• During the screening period, the percentage of predicted value for forced expiratory volume in one second (FEV1) before bronchodilator administration is ≥80%, and FEV1/forced vital capacity (FVC) is ≥70%.
• Have no pregnancy plan and voluntarily take effective contraception measures from time of screening to at least 90 days after the last dose (subjects and their partners)
Each drug is administered as a single dose.~TQC3302 inhalation spray (50/2.5/2.5μg); TQC3302 inhalation spray (100/2.5/2.5μg); Spiolto® Respimat® : Tiotropium bromide and olodaterol hydrochloride inhalation spray (2.5/2.5μg); Pulmicort® : Budesonide Powder for Inhalation (200μg)
Each drug is administered as a single dose.~TQC3302 inhalation spray (100/2.5/2.5μg); Spiolto® Respimat®: Tiotropium bromide and olodaterol hydrochloride inhalation spray (2.5/2.5μg) ; Pulmicort®: Budesonide Powder for Inhalation (200μg) TQC3302 inhalation spray (50/2.5/2.5μg)
Each drug is administered as a single dose.~Spiolto® Respimat®: Tiotropium bromide and olodaterol hydrochloride inhalation spray (2.5/2.5μg); Pulmicort® : Budesonide Powder for Inhalation (200μg); TQC3302 inhalation spray (50/2.5/2.5μg); TQC3302 inhalation spray (100/2.5/2.5μg)
Each drug is administered as a single dose.~Pulmicort®: Budesonide Powder for Inhalation (200μg); TQC3302 inhalation spray (50/2.5/2.5μg); TQC3302 inhalation spray (100/2.5/2.5μg); Spiolto® Respimat®: Tiotropium bromide and olodaterol hydrochloride inhalation spray (2.5/2.5μg)