Phase
Condition
N/ATreatment
TQC3927 powder for inhalation
TQC3927 powder for inhalation placebo
Clinical Study ID
Ages 40-70 All Genders
Study Summary
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
Connect with a study center
Aerospace Center Hospital
Beijing, Beijing 100049
ChinaSite Not Available
China Japan Friendship Hospital
Beijing, Beijing 100000
ChinaSite Not Available
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi 330038
ChinaSite Not Available
Heze Municipal Hospital
Heze, Shandong 274031
ChinaSite Not Available
Zibo Municipal Hospital
Zibo, Shandong 255400
ChinaSite Not Available
The Third People Hospital of Chengdu
Chengdu, Sichuan 610031
ChinaSite Not Available
The Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang 325027
ChinaSite Not Available

Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.