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

NCT ID: NCT07267130

Last Updated: 2025-12-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-25
• Study Completion Date: 2026-12-31

Brief 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.

Conditions

Chronic Obstructive Pulmonary Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TQC3302 inhalation spray (50/2.5/2.5μg)

Administered as a single dose

Group Type: EXPERIMENTAL

TQC3302 inhalation spray

Intervention Type: DRUG

TQC3302 inhalation spray is a targeted inhibitor

TQC3302/Spiolto® Respimat® /Pulmicort®

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)

Group Type: EXPERIMENTAL

TQC3302 inhalation spray+ TQC3302 inhalation spray+Tiotropium bromide and olodaterol hydrochloride inhalation spray +Budesonide Powder for Inhalation

Intervention Type: DRUG

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.

TQC3302/Pulmicort®/Spiolto® Respimat®

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)

Group Type: EXPERIMENTAL

TQC3302 inhalation spray+Tiotropium bromide and olodaterol hydrochloride inhalation spray +Budesonide Powder for Inhalation+ TQC3302 inhalation spray

Intervention Type: DRUG

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.

TQC3302/Spiolto® Respimat®/Pulmicort®

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)

Group Type: EXPERIMENTAL

Tiotropium bromide and olodaterol hydrochloride inhalation spray +Budesonide Powder for Inhalation+ TQC3302 inhalation spray+ TQC3302 inhalation spray

Intervention Type: DRUG

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.

Spiolto® Respimat® /Pulmicort®/TQC3302

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)

Group Type: EXPERIMENTAL

Budesonide Powder for Inhalation+ TQC3302 inhalation spray+ TQC3302 inhalation spray+ Tiotropium bromide and olodaterol hydrochloride inhalation spray

Intervention Type: DRUG

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.

TQC3302 inhalation spray (200/5/5μg)-single dose

TQC3302 inhalation spray is administered as a single dose.

Group Type: EXPERIMENTAL

TQC3302 inhalation spray

Intervention Type: DRUG

TQC3302 inhalation spray is a targeted inhibitor

TQC3302 inhalation spray (100/5/5μg)

Single dose during Day 1-Day 7

Group Type: EXPERIMENTAL

TQC3302 inhalation spray

Intervention Type: DRUG

TQC3302 inhalation spray is a targeted inhibitor

TQC3302 inhalation spray (200/5/5μg)

Single dose during Day 1-Day 7

Group Type: EXPERIMENTAL

TQC3302 inhalation spray

Intervention Type: DRUG

TQC3302 inhalation spray is a targeted inhibitor

Interventions

TQC3302 inhalation spray

TQC3302 inhalation spray is a targeted inhibitor

Intervention Type: DRUG

TQC3302 inhalation spray+ 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.

Intervention Type: DRUG

TQC3302 inhalation spray+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.

Intervention Type: DRUG

Tiotropium bromide and olodaterol hydrochloride inhalation spray +Budesonide Powder for Inhalation+ TQC3302 inhalation spray+ 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.

Intervention Type: DRUG

Budesonide Powder for Inhalation+ TQC3302 inhalation spray+ 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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

• Individuals with a history of glaucoma, functional constipation, benign prostatic hyperplasia, urinary tract obstruction, etc
• Current history of active tuberculosis, bronchiectasis or other non-specific lung diseases
• People who have received or are planning to receive inactive or active vaccines during the 30 days prior to the screening period and the entire study period
• Any history of drug allergies, Individuals with a specific history of allergies or allergies
• Had undergone surgery within 1 month prior to screening period or expected to undergo surgery during the study period
• People with special dietary requirements who cannot follow a standard diet;
• People who have potential difficulty in blood collection, or have a history of halo needles or blood sickness；
• History of drug or narcotics abuse or a positive result of urine drug test at screening
• People who have abnormal and clinically significant results in vital signs, physical examination, laboratory tests, Chest radiograph and abdominal ultrasound during screening period
• Subjects Positive for Any of Hepatitis B Virus Surface Antigen (HBsAg), Hepatitis C Virus Antibody (Anti-HCV), Human Immunodeficiency Virus Antibody (Anti-HIV), and Treponema Pallidum Antibody (Anti-TP)
• Pregnant or lactating women or those with positive blood pregnancy test results during the screening period

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

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

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

China Japan Friendship Hospital Beijing

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jintong Li, Doctor

Role: CONTACT

gcpljt@189.cn

15300059186

Facility Contacts

Jintong Li, Doctor

Role: primary

gcpljt@189.cn

15300059186

Other Identifiers

TQC3302-I-01

Identifier Type: -

Identifier Source: org_study_id