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CompletedNCT06711991Updated Aug 15, 2025

A Clinical Trial of TQC3927 Powder for Inhalation in Chronic Obstructive Pulmonary Disease

A Phase 1 interventional study of TQC3927 powder for inhalation and TQC3927 powder for inhalation placebo in Chronic Obstructive Pulmonary Disease, sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.. Completed at 7 sites in China. Open to participants aged 40 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-08-15.

Sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
40 Years to 70 Years
Sex
All
01

Study summary

This project is the stage of dose escalation, is was divided into single and multiple dose clinical study, This is a multi-center, randomized, double-blind, placebo-controlled , study to the safety, tolerability and pharmacokinetic characteristics of TQC3927 powder for inhalation in Chronic Obstructive Pulmonary Disease

02

Conditions studied

  • Chronic Obstructive Pulmonary Disease
03

In context

Pulmonary Disease, Chronic Obstructive

4,131 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 697 are open to participants now.

This study's enrollment of 48 is below the median of 70 across 2,926 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.

Browse Pulmonary Disease, Chronic Obstructive studies →

Lead sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd. is the lead sponsor of 313 studies on the registry; 75 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Between 18 and 45 years (inclusive)，both male and female
  • The subjects were able to undergo reproducible FEV1 lung function testing according to the American Thoracic Society/European Respiratory Society (ATS/ERS) 2005 standard during screening
  • Subject should weigh at least 45kg. And body mass index (BMI) within 18\~30 kg/m2
  • 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

Exclusion Criteria:

  • Patients with a history of glaucoma, functional constipation, prostate hyperplasia, urinary tract obstruction, etc
  • Individuals with a history of illegal drug abuse or who have tested positive for drug abuse screening during the screening period (including benzodiazepines, methamphetamine, cocaine, morphine, ketamine, tetrahydrocannabinol)
  • Participated in other clinical trials and received research interventions in the 3 months prior to participating in this trial
  • Screening for individuals who have used biologics within the past 3 months
  • Individuals who have lost blood or donated more than 400 mL of blood within 3 months prior to the experiment, or who have received blood transfusions or used blood products
  • Any clear history of drug or food allergies, especially those who are allergic to ingredients similar to the investigational drug
  • Screening for individuals who have frequently consumed alcohol within the previous 6 months (i.e. females consume more than 14 standard units of alcohol per week, males consume more than 21 standard units of alcohol per week (1 standard unit contains 14g of alcohol, such as 360 mL beer or 45 mL of 40% alcohol strong liquor or 150 mL wine) or are unable to abstain from alcohol during the trial period; Or those who test positive for alcohol breath test
  • History of any malignant tumors in organs or systems within the past 5 years, regardless of whether they have received treatment or not, except for local basal cell carcinoma of the skin
  • When screening, the sitting systolic blood pressure should be ≥ 160 mmHg, and the sitting diastolic blood pressure should be ≥ 100 mmHg; Pulse rate\<50 bpm or>100 bpm
  • Clinically significant apnea patients requiring continuous positive airway pressure (CPAP) or non-invasive positive airway pressure (NIPPV) devices
  • Those who require long-term oxygen therapy (oxygen therapy time>15 hours/day)
  • Individuals who have undergone lobectomy or lung volume reduction surgery within the 12 months prior to the start of the study
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
48 participants (actual)

Study arms

  • Experimental
    TQC3927 powder for inhalation

    TQC3927 powder for inhalation is administered as a single administration for 1 day and continuous administration for 6 days.

    Drug: TQC3927 powder for inhalation

  • Active comparator
    TQC3927 powder for inhalation placebo

    TQC3927 powder for inhalation placebo is administered as a single administration for 1 day and continuous administration for 6 days.

    Drug: TQC3927 powder for inhalation placebo

Interventions

  • DrugTQC3927 powder for inhalation

    TQC3927 is a targeted inhibitor

  • DrugTQC3927 powder for inhalation placebo

    A placebo without drug substance.

06

What researchers measure

Primary outcomes

  1. Adverse events (AE)

    The occurrence of all adverse events (AE) including abnormal laboratory test indicators.

    Time frame: From the use of the investigational drug until the last study visit, up to day 16

  2. Serious adverse events (SAE)

    The occurrence of all serious adverse events (SAE) .

    Time frame: From the use of the investigational drug until the last study visit, up to day 16

  3. Forced expiratory volume (FEV1) trough value changed from baseline

    After administration of Day1 and Day7, the FEV1 trough value changed from baseline. The changes in FEV1 before administration of Day3 and Day5 compared to baseline.

    Time frame: After administration of Day1 and Day7，before administration of Day3 and Day5

  4. Forced vital capacity (FVC) changes compared to baseline

    FVC changes compared to baseline at each lung function visit point.

    Time frame: After administration of Day1 and Day7，before administration of Day3 and Day5

  5. The peak FEV1 value changed from baseline

    After administration of Day1 and Day7, the peak FEV1 value changed from baseline.

    Time frame: After administration of Day1 and Day7，before administration of Day3 and Day5

  6. The area under the FEV1 curve of the average change from baseline

    The area under the FEV1 curve of the average change from baseline after administration of D1 and D7 ranges from 0-6h (AUC0-6h), 0-12h (AUC0-12h), 12-24h (AUC12-24h), 0-24h (AUC0-24h), and FVC AUC (0-24h).

    Time frame: After administration of Day1 and Day7，before administration of Day3 and Day5

  7. The change in chronic obstructive pulmonary disease (CAT) score from baseline

    The change in chronic obstructive pulmonary disease (CAT) score from baseline on the day after Day7 administration.

    Time frame: After administration of Day1 and Day7，before administration of Day3 and Day5

Secondary outcomes

  1. Peak concentration (Cmax)

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

    Time frame: Day1: pre-dose, at 15,30,45 minutes,1,2,4,6,8,12,24 hours after-dose, Day5: pre-dose, Day6: pre-dose, Day7: pre-dose, at 15,30,45 minutes,1,2,4,6,8,12,24,48,72 hours after-dose

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

    To characterize the pharmacokinetics of TQC3927 by assessment of area under the plasma concentration time curve from the first dose to a certain time point.

    Time frame: Day1: pre-dose, at 15,30,45 minutes,1,2,4,6,8,12,24 hours after-dose, Day5: pre-dose, Day6: pre-dose, Day7: pre-dose, at 15,30,45 minutes,1,2,4,6,8,12,24,48,72 hours after-dose

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

    To characterize the pharmacokinetics of TQC3927 by assessment of area under the plasma concentration time curve from 0 extrapolated to infinity.

    Time frame: Day1: pre-dose, at 15,30,45 minutes,1,2,4,6,8,12,24 hours after-dose, Day5: pre-dose, Day6: pre-dose, Day7: pre-dose, at 15,30,45 minutes,1,2,4,6,8,12,24,48,72 hours after-dose

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

    To characterize the pharmacokinetics of TQC3927 by assessment of time to reach maximum plasma concentration after single and multiple dosing.

    Time frame: Day1: pre-dose, at 15,30,45 minutes,1,2,4,6,8,12,24 hours after-dose, Day5: pre-dose, Day6: pre-dose, Day7: pre-dose, at 15,30,45 minutes,1,2,4,6,8,12,24,48,72 hours after-dose

  5. 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: Day1: pre-dose, at 15,30,45 minutes,1,2,4,6,8,12,24 hours after-dose, Day5: pre-dose, Day6: pre-dose, Day7: pre-dose, at 15,30,45 minutes,1,2,4,6,8,12,24,48,72 hours after-dose

  6. Apparent volume of distribution(Vd/F)

    Apparent volume of distribution of the TQC3927 in plasma

    Time frame: Day1: pre-dose, at 15,30,45 minutes,1,2,4,6,8,12,24 hours after-dose, Day5: pre-dose, Day6: pre-dose, Day7: pre-dose, at 15,30,45 minutes,1,2,4,6,8,12,24,48,72 hours after-dose

  7. Apparent clearance (CLz/F)

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

    Time frame: Day1: pre-dose, at 15,30,45 minutes,1,2,4,6,8,12,24 hours after-dose, Day5: pre-dose, Day6: pre-dose, Day7: pre-dose, at 15,30,45 minutes,1,2,4,6,8,12,24,48,72 hours after-dose

  8. End elimination rate (λz)

    Derived from semi logarithmic linear regression of eliminating phase concentration points.

    Time frame: Day1: pre-dose, at 15,30,45 minutes,1,2,4,6,8,12,24 hours after-dose, Day5: pre-dose, Day6: pre-dose, Day7: pre-dose, at 15,30,45 minutes,1,2,4,6,8,12,24,48,72 hours after-dose

  9. Residual area percentage (AUC_%Extrap)

    Residual area percentage of the TQC3927 in plasma.

    Time frame: Day1: pre-dose, at 15,30,45 minutes,1,2,4,6,8,12,24 hours after-dose, Day5: pre-dose, Day6: pre-dose, Day7: pre-dose, at 15,30,45 minutes,1,2,4,6,8,12,24,48,72 hours after-dose

  10. Average dwell time(MRT0-t)

    The average residence time from 0:00 to the last measurable concentration time point.

    Time frame: Day1: pre-dose, at 15,30,45 minutes,1,2,4,6,8,12,24 hours after-dose, Day5: pre-dose, Day6: pre-dose, Day7: pre-dose, at 15,30,45 minutes,1,2,4,6,8,12,24,48,72 hours after-dose

  11. Average dwell time(MRT0-∞)

    Average residence time from 0:00 to infinity.

    Time frame: Day1: pre-dose, at 15,30,45 minutes,1,2,4,6,8,12,24 hours after-dose, Day5: pre-dose, Day6: pre-dose, Day7: pre-dose, at 15,30,45 minutes,1,2,4,6,8,12,24,48,72 hours after-dose

07

Study locations

7 sites
  • China Japan Friendship Hospital
    Beijing, Beijing Municipality 100000, China
  • Aerospace Center Hospital
    Beijing, Beijing Municipality 100049, China
  • The First Affiliated Hospital of Nanchang University
    Nanchang, Jiangxi 330038, China
  • Heze Municipal Hospital
    Heze, Shandong 274031, China
  • Zibo Municipal Hospital
    Zibo, Shandong 255400, China
  • The Third People Hospital of Chengdu
    Chengdu, Sichuan 610031, China
  • The Second Affiliated Hospital of Wenzhou Medical University
    Wenzhou, Zhejiang 325027, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 15, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06711991
Lead sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Responsible party
Sponsor
First posted
Dec 2, 2024
Start date
Feb 11, 2025
Primary completion
Aug 11, 2025
Completion
Aug 11, 2025
Last update
Aug 15, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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