NCT07267130

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

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 57 (estimated)
• Sponsor: Chia Tai Tianqing Pharmaceutical (Guangzhou) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
DRUG	TQC3302 inhalation spray	TQC3302 inhalation spray is a targeted inhibitor
DRUG	TQC3302 inhalation spray+Tiotropium bromide and olodaterol hydrochloride inhalation spray +Budesonide Powder for Inhalation	TQC3302 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.
DRUG	Tiotropium bromide and olodaterol hydrochloride inhalation spray +Budesonide Powder for Inhalation+ TQC3302 inhalation spray	TQC3302 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.
DRUG	Budesonide Powder for Inhalation+ TQC3302 inhalation spray+ Tiotropium bromide and olodaterol hydrochloride inhalation spray	TQC3302 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.
DRUG	TQC3302 inhalation spray	TQC3302 inhalation spray is a targeted inhibitor

Timeline

• Start date: 2025-11-25
• Primary completion: 2026-10-01
• Completion: 2026-12-01
• First posted: 2025-12-05
• Last updated: 2026-03-10

Locations

1 site across 1 country: China