RecruitingPhase 1NCT07267130

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


Sponsor

Chia Tai Tianqing Pharmaceutical (Guangzhou) Co., Ltd.

Enrollment

57 participants

Start Date

Nov 25, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This is an early-phase safety study testing a new inhaled medication called TQC3302 in healthy adult volunteers. The goal is to understand how the body absorbs, processes, and tolerates this drug when inhaled. No disease treatment is involved — researchers want to establish safety data in healthy people first. **You may be eligible if...** - You are a healthy adult between 18 and 55 years old - You weigh at least 50 kg (if male) or 45 kg (if female) with a BMI in the healthy range - You can successfully use an inhaler device after training - Your lung function tests are normal - You and your partner agree to use effective contraception during the study and for 90 days after the last dose **You may NOT be eligible if...** - You have a history of glaucoma, benign prostate enlargement, urinary obstruction, or chronic constipation - You have active tuberculosis, bronchiectasis, or other lung diseases - You have any drug allergies or significant health conditions - You have had surgery in the past month or plan surgery during the study - You have hepatitis B, hepatitis C, HIV, or syphilis - You are pregnant or breastfeeding - You use tobacco, recreational drugs, or alcohol excessively Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTQC3302 inhalation spray

TQC3302 inhalation spray is a targeted inhibitor

DRUGTQC3302 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.

DRUGTiotropium 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.

DRUGBudesonide 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.

DRUGTQC3302 inhalation spray

TQC3302 inhalation spray is a targeted inhibitor


Locations(1)

China Japan Friendship Hospital Beijing

Beijing, Beijing Municipality, China

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NCT07267130


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