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

Last updated: August 13, 2025
Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Overall Status: Completed

Phase

1

Condition

N/A

Treatment

TQC3927 powder for inhalation

TQC3927 powder for inhalation placebo

Clinical Study ID

NCT06711991
TQC3927-I-02
  • Ages 40-70
  • All Genders

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Between 18 and 45 years (inclusive),both male and female

  • The subjects were able to undergo reproducible FEV1 lung function testing accordingto the American Thoracic Society/European Respiratory Society (ATS/ERS) 2005standard 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 fromtime of screening to at least 90 days after the last dose (subjects and theirpartners)

Exclusion

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 fordrug abuse screening during the screening period (including benzodiazepines,methamphetamine, cocaine, morphine, ketamine, tetrahydrocannabinol)

  • Participated in other clinical trials and received research interventions in the 3months 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 monthsprior to the experiment, or who have received blood transfusions or used bloodproducts

  • Any clear history of drug or food allergies, especially those who are allergic toingredients similar to the investigational drug

  • Screening for individuals who have frequently consumed alcohol within the previous 6months (i.e. females consume more than 14 standard units of alcohol per week, malesconsume 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 mLwine) or are unable to abstain from alcohol during the trial period; Or those whotest 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 basalcell carcinoma of the skin

  • When screening, the sitting systolic blood pressure should be ≥ 160 mmHg, and thesitting 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

Study Design

Total Participants: 48
Treatment Group(s): 2
Primary Treatment: TQC3927 powder for inhalation
Phase: 1
Study Start date:
February 11, 2025
Estimated Completion Date:
August 11, 2025

Connect with a study center

  • Aerospace Center Hospital

    Beijing, Beijing 100049
    China

    Site Not Available

  • China Japan Friendship Hospital

    Beijing, Beijing 100000
    China

    Site Not Available

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi 330038
    China

    Site Not Available

  • Heze Municipal Hospital

    Heze, Shandong 274031
    China

    Site Not Available

  • Zibo Municipal Hospital

    Zibo, Shandong 255400
    China

    Site Not Available

  • The Third People Hospital of Chengdu

    Chengdu, Sichuan 610031
    China

    Site Not Available

  • The Second Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang 325027
    China

    Site Not Available

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