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

NCT07267130 | Recruiting Phase 1

• 1 other identifier: TQC3302-I-01
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Treatment Emergent Adverse Event

  The incidence and severity of adverse events after treatment From the use of the investigational drug until the last study visit.

  From the use of the investigational drug until the last study visit, up to Day 14

• The subject with abnormal security check

  The frequency, incidence, and severity of laboratory tests, vital signs, physical examinations, electrocardiogram examinations, etc.

  From the use of the investigational drug until the last study visit, up to Day 14

Secondary Outcomes (20)

• Cmax after dose

  Single dose：pre-dose, at 2,5,8,12,25,45 minutes,1,2,4,8,12,24, 48,72,120 hours after-dose (When using Budesonide Powder for Inhalation, there is no need to monitor at 48, 72, and 120 hours after the end of administration)

• Area Under the Concentration-Time Curve From 0 to Last Observation (AUC [0-t])

  Single dose：pre-dose, at 2,5,8,12,25,45 minutes,1,2,4,8,12,24, 48,72,120 hours after-dose (When using Budesonide Powder for Inhalation, there is no need to monitor at 48, 72, and 120 hours after the end of administration)

• Area Under the Concentration-Time Curve From Zero to Infinity (AUC [0-infinity])

  Single dose：pre-dose, at 2,5,8,12,25,45 minutes,1,2,4,8,12,24, 48,72,120 hours after-dose (When using Budesonide Powder for Inhalation, there is no need to monitor at 48, 72, and 120 hours after the end of administration)

• Time to reach maximum (peak) plasma concentration following drug administration (Tmax)

  Single dose：pre-dose, at 2,5,8,12,25,45 minutes,1,2,4,8,12,24, 48,72,120 hours after-dose (When using Budesonide Powder for Inhalation, there is no need to monitor at 48, 72, and 120 hours after the end of administration)

• Half-life (t1/2)

  Single dose：pre-dose, at 2,5,8,12,25,45 minutes,1,2,4,8,12,24, 48,72,120 hours after-dose (When using Budesonide Powder for Inhalation, there is no need to monitor at 48, 72, and 120 hours after the end of administration)

Study Arms (9)

TQC3302 inhalation spray (50/2.5/2.5μg)

EXPERIMENTAL

Administered as a single dose

Drug: TQC3302 inhalation spray

TQC3302/Spiolto® Respimat® /Pulmicort®

EXPERIMENTAL

Each drug is administered as a single dose. TQC3302 inhalation spray (200/2.5/2.5μg); Spiolto® Respimat® : Tiotropium bromide and olodaterol hydrochloride inhalation spray (2.5/2.5μg); Pulmicort® : Budesonide Powder for Inhalation (200μg)

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

Pulmicort®/Spiolto® Respimat®

EXPERIMENTAL

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 (200/2.5/2.5μg)

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

Spiolto® Respimat® /Pulmicort®/TQC3302

EXPERIMENTAL

Each drug is administered as a single dose. Pulmicort®: Budesonide Powder for Inhalation (200μg); TQC3302 inhalation spray (200/2.5/2.5μg); Spiolto® Respimat®: Tiotropium bromide and olodaterol hydrochloride inhalation spray (2.5/2.5μg)

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

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

EXPERIMENTAL

TQC3302 inhalation spray is administered as a single dose.

Drug: TQC3302 inhalation spray

TQC3302 inhalation spray (400/5/5μg)

EXPERIMENTAL

TQC3302 inhalation spray is administered as a single dose

Drug: TQC3302 inhalation spray

TQC3302 inhalation spray (200/5/5μg)

EXPERIMENTAL

Single dose during Day 1-Day 7

Drug: TQC3302 inhalation spray

TQC3302 inhalation spray (400/5/5μg)-single dose

EXPERIMENTAL

single dose during Day 1-Day 7

Drug: TQC3302 inhalation spray

TQC3302 inhalation spray (400/5/5μg) -two dose

EXPERIMENTAL

Two dose during Day 1-Day 7

Drug: TQC3302 inhalation spray

Interventions

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

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

Pulmicort®/Spiolto® Respimat®

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

TQC3302 inhalation spray DRUG

TQC3302 inhalation spray is a targeted inhibitor

TQC3302 inhalation spray (50/2.5/2.5μg)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical (Guangzhou) Co., Ltd.: lead

Study Sites (1)

China Japan Friendship Hospital Beijing

Beijing, Beijing Municipality, 100000, China

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Inhalation; Tiotropium Bromide

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiratory Mechanics; Respiration; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Central Study Contacts

Jintong Li, Doctor

CONTACT

15300059186; gcpljt@189.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: December 5, 2025
• Study Start: November 25, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 10, 2026

Record last verified: 2025-08

Locations

CN (1)