drugset / Trial / NCT07267130

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

NCT07267130

Phase 1 Recruiting 57 enrolled Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
RandomizedCrossoverOpen-labelTreatment

Summary

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.

Timeline

Start
2025-11-25
Primary completion
2026-10
Completion
2026-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Budesonide Small molecule 200 ug Inhaled
Subject TQC3302 Unknown 50 ug Inhaled
Subject TQC3302 Unknown 200 ug Inhaled
Subject TQC3302 Unknown 400 ug Inhaled
Subject Tiotropium bromide and olodaterol hydrochloride Unknown 2.5 ug Inhaled