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NCT Number: NCT07267130

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

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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

China Japan Friendship Hospital Beijing

Beijing, Beijing Municipality, 100000, China

Location status: Recruiting

Location contact

Jintong Li, Doctor

CONTACT

[email protected]

15300059186

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TQC3302 inhalation spray

Drug

TQC3302 inhalation spray is a targeted inhibitor

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.

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.

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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)

    The Cmax is the maximum observed plasma concentration of study drug

  2. 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)

    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

  3. 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)

    To characterize the pharmacokinetics of TQC3302 by assessment of area under the plasma concentration time curve from 0 extrapolated to infinity.

  4. 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)

    To characterize the pharmacokinetics of TQC3302 by assessment of time to reach maximum plasma concentration after single dosing.

  5. 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)

    Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.

  6. 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 volume of distribution of the TQC3302 in plasma.

  7. 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)

    Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the body.

  8. 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

    The Cmax is the maximum observed plasma concentration of study drug.

  9. 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

    To characterize the pharmacokinetics of TQC3302 by assessment of time to reach maximum plasma concentration after the first administration.

  10. 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

    Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.

  11. 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

    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.

  12. 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

    To characterize the pharmacokinetics of TQC3302 by assessment of area under the plasma concentration time curve from 0 extrapolated to infinity

  13. 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

    The Cmax is the maximum observed plasma concentration of study drug

  14. 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

    To characterize the pharmacokinetics of TQC3302 by assessment of time to reach maximum plasma concentration after multiple dosing

  15. 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

    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

  16. 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

    To characterize the pharmacokinetics of TQC3302 by assessment of area under the plasma concentration time curve from 0 extrapolated to infinity.

  17. 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

    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.

  18. 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

    Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.

  19. 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 peak concentration (Rac (Cmax))

  20. 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

    Accumulation ratio based on AUC

Study contacts

Contact information is provided by the study sponsor or research team.

Jintong Li, Doctor

CONTACT

[email protected]

15300059186

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 5, 2025
Registry last updated
Mar 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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