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

CTTQ

Status and phase: Completed; Phase 1

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Drug: TQC3927 powder for inhalation placebo; Drug: TQC3927 powder for inhalation

Study type: Interventional

Funder types: Industry

Identifiers

NCT06711991

TQC3927-I-02

Details and patient eligibility

About

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

Enrollment: 48 patients

Sex: All

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

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

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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48 participants in 2 patient groups

TQC3927 powder for inhalation

Experimental group

Description:

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

Treatment:

Drug: TQC3927 powder for inhalation

TQC3927 powder for inhalation placebo

Active Comparator group

Description:

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

Treatment:

Drug: TQC3927 powder for inhalation placebo