Chronic Obstructive Pulmonary DiseasePhase 1NCT07267130
A Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetic Profile of TQC3302 Inhalation Spray in Healthy Adult Subjects
A Phase 1 study testing TQC3302 inhalation spray, TQC3302 inhalation spray+Tiotropium bromide and olodaterol hydrochloride inhalation spray +Budesonide Powder for Inhalation and Tiotropium bromide and olodaterol hydrochloride inhalation spray +Budesonide Powder for Inhalation+ TQC3302 inhalation spray in people with Chronic Obstructive Pulmonary Disease, run by Chia Tai Tianqing Pharmaceutical (Guangzhou) Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- TQC3302 inhalation spray, TQC3302 inhalation spray+Tiotropium bromide and olodaterol hydrochloride inhalation spray +Budesonide Powder for Inhalation and Tiotropium bromide and olodaterol hydrochloride inhalation spray +Budesonide Powder for Inhalation+ TQC3302 inhalation spray
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteChina
- Study dates
- 25 Nov 2025to 21 Aug 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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;
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- 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
Trial locations and contacts
1 site in 1 country.
China1 site
China Japan Friendship Hospital Beijing
Beijing, Beijing Municipality, 100000
About this study
Official title: 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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- TQC3302 inhalation spray, TQC3302 inhalation spray+Tiotropium bromide and olodaterol hydrochloride inhalation spray +Budesonide Powder for Inhalation, Tiotropium bromide and olodaterol hydrochloride inhalation spray +Budesonide Powder for Inhalation+ TQC3302 inhalation spray, Budesonide Powder for Inhalation+ TQC3302 inhalation spray+ Tiotropium bromide and olodaterol hydrochloride inhalation spray
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQC3302 inhalation sprayDrug
TQC3302 inhalation spray is a targeted inhibitor
TQC3302 inhalation spray+Tiotropium bromide and olodaterol hydrochloride inhalation spray +Budesonide Powder for InhalationDrug
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.
Tiotropium bromide and olodaterol hydrochloride inhalation spray +Budesonide Powder for Inhalation+ TQC3302 inhalation sprayDrug
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.
Budesonide Powder for Inhalation+ TQC3302 inhalation spray+ Tiotropium bromide and olodaterol hydrochloride inhalation sprayDrug
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 sprayDrug
TQC3302 inhalation spray is a targeted inhibitor
| Study group | Role | What they receive |
|---|---|---|
| TQC3302 inhalation spray (50/2.5/2.5μg) | Experimental | Administered as a single dose Receives: 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) Receives: 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) Receives: 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) Receives: 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. Receives: Drug: TQC3302 inhalation spray |
| TQC3302 inhalation spray (400/5/5μg) | Experimental | TQC3302 inhalation spray is administered as a single dose Receives: Drug: TQC3302 inhalation spray |
| TQC3302 inhalation spray (200/5/5μg) | Experimental | Single dose during Day 1-Day 7 Receives: Drug: TQC3302 inhalation spray |
| TQC3302 inhalation spray (400/5/5μg)-single dose | Experimental | single dose during Day 1-Day 7 Receives: Drug: TQC3302 inhalation spray |
| TQC3302 inhalation spray (400/5/5μg) -two dose | Experimental | Two dose during Day 1-Day 7 Receives: Drug: TQC3302 inhalation spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From the use of the investigational drug until the last study visit, up to Day 14
Secondary outcomes (20)
Cmax after dose
The Cmax is the maximum observed plasma concentration of study drug
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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))
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start25 Nov 2025
- Primary completion21 Aug 2026
- Study completion21 Aug 2026
Why it stopped: This study shall be terminated as a result of strategic adjustments to the company-sponsored research and development of TQC3302 Inhalation Spray.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical (Guangzhou) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07267130
- Sponsor's protocol ID
- TQC3302-I-01
- Status last verified
- Aug 2025
- First submitted
- 25 Nov 2025
- Last updated
- 27 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetic Profile of TQC3302 Inhalation Spray in Healthy Adult Subjects in China
- ClinicalTrials.gov ID
- NCT07267130
- Acronym / sponsor ID
- TQC3302-I-01
- Conditions
- Chronic Obstructive Pulmonary Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study shall be terminated as a result of strategic adjustments to the company-sponsored research and development of TQC3302 Inhalation Spray.
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical (Guangzhou) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Nov 2025 (actual)
- Primary completion
- 21 Aug 2026 (actual)
- Study completion
- 21 Aug 2026 (actual)
- First posted
- 5 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| TQC3302 inhalation spray (50/2.5/2.5μg) | Experimental | Drug: TQC3302 inhalation sprayAdministered as a single dose |
| TQC3302/Spiolto® Respimat® /Pulmicort® | Experimental | Drug: TQC3302 inhalation spray+Tiotropium bromide and olodaterol hydrochloride inhalation spray +Budesonide Powder for InhalationEach 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) |
| Pulmicort®/Spiolto® Respimat® | Experimental | Drug: Tiotropium bromide and olodaterol hydrochloride inhalation spray +Budesonide Powder for Inhalation+ TQC3302 inhalation sprayEach 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) |
| Spiolto® Respimat® /Pulmicort®/TQC3302 | Experimental | Drug: Budesonide Powder for Inhalation+ TQC3302 inhalation spray+ Tiotropium bromide and olodaterol hydrochloride inhalation sprayEach 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) |
| TQC3302 inhalation spray (200/5/5μg)-single dose | Experimental | Drug: TQC3302 inhalation sprayTQC3302 inhalation spray is administered as a single dose. |
| TQC3302 inhalation spray (400/5/5μg) | Experimental | Drug: TQC3302 inhalation sprayTQC3302 inhalation spray is administered as a single dose |
| TQC3302 inhalation spray (200/5/5μg) | Experimental | Drug: TQC3302 inhalation spraySingle dose during Day 1-Day 7 |
| TQC3302 inhalation spray (400/5/5μg)-single dose | Experimental | Drug: TQC3302 inhalation spraysingle dose during Day 1-Day 7 |
| TQC3302 inhalation spray (400/5/5μg) -two dose | Experimental | Drug: TQC3302 inhalation sprayTwo dose during Day 1-Day 7 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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%.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TQC3302 inhalation sprayTQC3302 inhalation spray is a targeted inhibitor | Drug | TQC3302 inhalation spray (50/2.5/2.5μg) |
| TQC3302 inhalation spray+Tiotropium bromide and olodaterol hydrochloride inhalation spray +Budesonide Powder for InhalationTQC3302 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/Spiolto® Respimat® /Pulmicort® |
| Tiotropium bromide and olodaterol hydrochloride inhalation spray +Budesonide Powder for Inhalation+ TQC3302 inhalation sprayTQC3302 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 | Pulmicort®/Spiolto® Respimat® |
| Budesonide Powder for Inhalation+ TQC3302 inhalation spray+ Tiotropium bromide and olodaterol hydrochloride inhalation sprayTQC3302 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 | Spiolto® Respimat® /Pulmicort®/TQC3302 |
| TQC3302 inhalation sprayTQC3302 inhalation spray is a targeted inhibitor | Drug | TQC3302 inhalation spray (200/5/5μg), TQC3302 inhalation spray (200/5/5μg)-single dose, TQC3302 inhalation spray (400/5/5μg), TQC3302 inhalation spray (400/5/5μg) -two dose, TQC3302 inhalation spray (400/5/5μg)-single dose |
Primary outcome
Treatment Emergent Adverse Event
Time frame: From the use of the investigational drug until the last study visit, up to Day 14
The incidence and severity of adverse events after treatment From the use of the investigational drug until the last study visit.
The subject with abnormal security check
Time frame: From the use of the investigational drug until the last study visit, up to Day 14
The frequency, incidence, and severity of laboratory tests, vital signs, physical examinations, electrocardiogram examinations, etc.
20 secondary outcomes
Cmax after dose
Time frame: 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])
Time frame: 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])
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Multiple dosing: at 2, 5, 8, 12, 25, 45 minutes, 1, 2, 4, 8, 12 hours after the first administration
Peak concentration (Cmax)
Time frame: 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
Time frame: 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])
Time frame: 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])
Time frame: 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
Time frame: 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
Time frame: 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))
Time frame: 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
Time frame: 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
Results and safety
The study was stopped early (reason given: This study shall be terminated as a result of strategic adjustments to the company-sponsored research and development of TQC3302 Inhalation Spray.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TQC3302 inhalation spray, TQC3302 inhalation spray+Tiotropium bromide and olodaterol hydrochloride inhalation spray +Budesonide Powder for Inhalation and Tiotropium bromide and olodaterol hydrochloride inhalation spray +Budesonide Powder for Inhalation+ TQC3302 inhalation spray in people with Chronic Obstructive Pulmonary Disease, run by Chia Tai Tianqing Pharmaceutical (Guangzhou) Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: This study shall be terminated as a result of strategic adjustments to the company-sponsored research and development of TQC3302 Inhalation Spray.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Emergent Adverse Event (time frame: From the use of the investigational drug until the last study visit, up to Day 14). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.