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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Drug: TQC3302 inhalation spray; Drug: TQC3302 inhalation spray+Tiotropium bromide and olodaterol hydrochloride inhalation spray +Budesonide Powder for Inhalation; Drug: Tiotropium bromide and olodaterol hydrochloride inhalation spray +Budesonide Powder for Inhalation+ TQC3302 inhalation spray; Drug: Budesonide Powder for Inhalation+ TQC3302 inhalation spray+ Tiotropium bromide and olodaterol hydrochloride inhalation spray

• Study Type: Interventional
• Enrollment (Estimated): 57
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Jintong Li, Doctor; Phone Number: 15300059186; Email: gcpljt@189.cn

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100000
      • Recruiting
      • China Japan Friendship Hospital Beijing
      • Contact: Jintong Li, Doctor; Phone Number: 15300059186; Email: gcpljt@189.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

9

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TQC3302 inhalation spray (50/2.5/2.5μg); Administered as a single dose	Drug: TQC3302 inhalation spray; TQC3302 inhalation spray is a targeted inhibitor
Experimental: TQC3302 inhalation spray (200/5/5μg)-single dose; TQC3302 inhalation spray is administered as a single dose.	Drug: TQC3302 inhalation spray; TQC3302 inhalation spray is a targeted inhibitor
Experimental: TQC3302 inhalation spray (200/5/5μg); Single dose during Day 1-Day 7	Drug: TQC3302 inhalation spray; TQC3302 inhalation spray is a targeted inhibitor
Experimental: TQC3302/Spiolto® Respimat® /Pulmicort®; 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; 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.
Experimental: Pulmicort®/Spiolto® Respimat®; 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; 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.
Experimental: Spiolto® Respimat® /Pulmicort®/TQC3302; 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 is a targeted inhibitor, Tiotropium bromide and olodaterol hydrochloride inhalation spray is a targeted inhibitor, Budesonide Powder for Inhalation is a Inhaled Corticosteroids.
Experimental: TQC3302 inhalation spray (400/5/5μg); TQC3302 inhalation spray is administered as a single dose	Drug: TQC3302 inhalation spray; TQC3302 inhalation spray is a targeted inhibitor
Experimental: TQC3302 inhalation spray (400/5/5μg)-single dose; single dose during Day 1-Day 7	Drug: TQC3302 inhalation spray; TQC3302 inhalation spray is a targeted inhibitor
Experimental: TQC3302 inhalation spray (400/5/5μg) -two dose; Two dose during Day 1-Day 7	Drug: TQC3302 inhalation spray; TQC3302 inhalation spray is a targeted inhibitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax after dose	The Cmax is the maximum observed plasma concentration of study drug	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])	To characterize the pharmacokinetics of TQC3302 by assessment of area under the plasma concentration time curve from the first dose to a certain time point	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])	To characterize the pharmacokinetics of TQC3302 by assessment of area under the plasma concentration time curve from 0 extrapolated to 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)	To characterize the pharmacokinetics of TQC3302 by assessment of time to reach maximum plasma concentration after single dosing.	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)	Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.	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)
Apparent volume of distribution (Vd/F)	Apparent volume of distribution of the TQC3302 in plasma.	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)
Apparent clearance (CL/F)	Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the body.	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)
Peak concentration (Cmax) after the first administration	The Cmax is the maximum observed plasma concentration of study drug.	Multiple dosing: at 2, 5, 8, 12, 25, 45 minutes, 1, 2, 4, 8, 12 hours after the first administration
Time to reach maximum (peak) plasma concentration after the first administration (Tmax)	To characterize the pharmacokinetics of TQC3302 by assessment of time to reach maximum plasma concentration after the first administration.	Multiple dosing: at 2, 5, 8, 12, 25, 45 minutes, 1, 2, 4, 8, 12 hours after the first administration
Half-life after the first administration	Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.	Multiple dosing: at 2, 5, 8, 12, 25, 45 minutes, 1, 2, 4, 8, 12 hours after the first administration
Area Under the Concentration-Time Curve From 0 to Last Observation after the first administration	To characterize the pharmacokinetics of TQC3302 by assessment of area under the plasma concentration time curve from the first dose to a certain time point.	Multiple dosing: at 2, 5, 8, 12, 25, 45 minutes, 1, 2, 4, 8, 12 hours after the first administration
Area Under the Concentration-Time Curve From Zero to Infinity after the first administration	To characterize the pharmacokinetics of TQC3302 by assessment of area under the plasma concentration time curve from 0 extrapolated to infinity	Multiple dosing: at 2, 5, 8, 12, 25, 45 minutes, 1, 2, 4, 8, 12 hours after the first administration
Peak concentration (Cmax)	The Cmax is the maximum observed plasma concentration of study drug	Multiple dosing: at 2, 5, 8, 12, 25, 45 minutes, 1, 2, 4, 8, 12, 24 hours after the first dose, before Day 5, 6, 7, at 2, 5, 8,1 2, 25, 45 minutes, 1, 2 , 4, 8, 12, 24, 48, 72, 120 hours after Day 7 dose
Time to reach maximum (peak) plasma concentration following drug administration	To characterize the pharmacokinetics of TQC3302 by assessment of time to reach maximum plasma concentration after multiple dosing	Multiple dosing: at 2, 5, 8, 12, 25, 45 minutes, 1, 2, 4, 8, 12, 24 hours after the first dose, before Day 5, 6, 7, at 2, 5, 8,1 2, 25, 45 minutes, 1, 2 , 4, 8, 12, 24, 48, 72, 120 hours after Day 7 dose
Area Under the Concentration-Time Curve From 0 to Last Observation (AUC [0-t])	To characterize the pharmacokinetics of TQC3302 by assessment of area under the plasma concentration time curve from the first dose to a certain time point	Multiple dosing: at 2, 5, 8, 12, 25, 45 minutes, 1, 2, 4, 8, 12, 24 hours after the first dose, before Day 5, 6, 7, at 2, 5, 8,1 2, 25, 45 minutes, 1, 2 , 4, 8, 12, 24, 48, 72, 120 hours after Day 7 dose
Area Under the Concentration-Time Curve From Zero to Infinity (AUC [0-infinity])	To characterize the pharmacokinetics of TQC3302 by assessment of area under the plasma concentration time curve from 0 extrapolated to infinity.	Multiple dosing: at 2, 5, 8, 12, 25, 45 minutes, 1, 2, 4, 8, 12, 24 hours after the first dose, before Day 5, 6, 7, at 2, 5, 8,1 2, 25, 45 minutes, 1, 2 , 4, 8, 12, 24, 48, 72, 120 hours after Day 7 dose
Area Under the Concentration-Time Profile From Time Zero to the Dosing Interval Tau	Area Under the Concentration-Time Profile From Time Zero to the Dosing Interval Tau (AUCtau) of TQC3302 from the first dose to a certain time point.	Multiple dosing: at 2, 5, 8, 12, 25, 45 minutes, 1, 2, 4, 8, 12, 24 hours after the first dose, before Day 5, 6, 7, at 2, 5, 8,1 2, 25, 45 minutes, 1, 2 , 4, 8, 12, 24, 48, 72, 120 hours after Day 7 dose
Half-life (t1/2): Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma	Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.	Multiple dosing: at 2, 5, 8, 12, 25, 45 minutes, 1, 2, 4, 8, 12, 24 hours after the first dose, before Day 5, 6, 7, at 2, 5, 8,1 2, 25, 45 minutes, 1, 2 , 4, 8, 12, 24, 48, 72, 120 hours after Day 7 dose
Accumulation ratio based on peak concentration (Rac (Cmax))	Accumulation ratio based on peak concentration (Rac (Cmax))	Multiple dosing: at 2, 5, 8, 12, 25, 45 minutes, 1, 2, 4, 8, 12, 24 hours after the first dose, before Day 5, 6, 7, at 2, 5, 8,1 2, 25, 45 minutes, 1, 2 , 4, 8, 12, 24, 48, 72, 120 hours after Day 7 dose
Accumulation ratio based on AUC	Accumulation ratio based on AUC	Multiple dosing: at 2, 5, 8, 12, 25, 45 minutes, 1, 2, 4, 8, 12, 24 hours after the first dose, before Day 5, 6, 7, at 2, 5, 8,1 2, 25, 45 minutes, 1, 2 , 4, 8, 12, 24, 48, 72, 120 hours after Day 7 dose

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: November 25, 2025
• First Submitted That Met QC Criteria: November 25, 2025
• First Posted (Actual): December 5, 2025

Study Record Updates

• Last Update Posted (Actual): March 10, 2026
• Last Update Submitted That Met QC Criteria: March 8, 2026
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pathological Conditions, Signs and Symptoms; Pulmonary Disease, Chronic Obstructive; Organic Chemicals; Heterocyclic Compounds; Circulatory and Respiratory Physiological Phenomena; Alkaloids; Aza Compounds; Respiratory Mechanics; Respiration; Respiratory Physiological Phenomena; Heterocyclic Compounds, Bridged-Ring; Tropanes; Azabicyclo Compounds; Bridged Bicyclo Compounds, Heterocyclic; Scopolamine Derivatives; Tiotropium Bromide; Inhalation
• Other Study ID Numbers: TQC3302-I-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No