Phase 1 Study to Assess Safety, Tolerability, and Drug Behavior of TQC3302 Inhalation Spray in Healthy Adults Aged 18 to 55

What this Trial Is About

Researchers are evaluating the safety, tolerability, and how the body processes TQC3302 inhalation spray in healthy adults between 18 and 55 years old. This Phase 1 clinical study uses both a single-center, open-label design and a randomized three-sequence, three-period crossover design for different groups. The study focuses on measuring adverse events and drug levels in the body after single and multiple inhalations of TQC3302 and comparator inhalation sprays in healthy participants. Participants receive single doses or multiple doses of TQC3302 inhalation spray alone or combined with other inhaled drugs like Tiotropium bromide and olodaterol hydrochloride inhalation spray or Budesonide Powder for Inhalation. Different dosing schedules cover single doses during days 1 to 7 and two doses during this period. The study groups are randomized to receive these treatments in various sequences to compare safety and pharmacokinetic profiles. During the study, participants undergo detailed safety assessments including monitoring for side effects up to day 14 after dosing. Blood samples are collected at multiple time points to measure drug concentrations and pharmacokinetic parameters like peak concentration, clearance, and half-life. The study also includes physical exams, lung function tests, laboratory tests, chest X-rays, and ultrasound evaluations during screening. The total participation spans from screening through follow-up visits up to 14 days after the last dose.

A Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetic Profile of TQC3302 Inhalation Spray in Healthy Adult Subjects