Phase I Clinical Study on the Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Characteristics of Single/Multiple Dose Escalation of TQC3721 Inhalation Powder in Patients With Chronic Obstructive Pulmonary Disease

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.1 site in 1 country72 target enrollmentDecember 3, 2024

ConditionsChronic Obstructive Pulmonary Disease (COPD)

InterventionsTQC3721 inhalation powder Placebo for TQC3721 inhalation powder

DrugsTQC3721 inhalation powder Placebo for TQC3721 inhalation powder

Overview

Phase: Phase 1
Intervention: TQC3721 inhalation powder
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Enrollment: 72
Locations: 1
Primary Endpoint: Adverse events (AE)
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a randomized, double-blind, placebo-controlled, dose escalation, multicenter study design. The purpose is to evaluate the safety, tolerability, pharmacokinetics, and pharmacokinetic characteristics of TQC3721 inhalation powder in Chronic Obstructive Pulmonary Disease(COPD) patients with single/multiple dose escalation.

Registry

clinicaltrials.gov

Start Date

December 3, 2024

End Date

September 2025

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age: 40-75 years old, male or female;
•During screening, according to the Global Oceanographic Library for Discovery (GOLD)guidelines (2024), patients diagnosed with stable moderate to severe COPD should have Force Expiratory Volume in 1 second (FEV1)/ forced vital capacity (FVC)\<0.7 after inhaling bronchodilators; 40% ≤ FEV1 accounts for ≤ 80% of the expected value;
•When screening, after inhaling salbutamol aerosol for 4 times, there is a certain reversibility in the airway: the absolute value of FEV1 improves by more than 100ml;
•Being able to adjust the current COPD treatment or for COPD patients with initial treatment, prescribed bronchodilators, including Long-acting Muscarinic Antagonists (LAMA) and/or Long-acting β2-agonist (LABA) inhaled drugs, can be discontinued during the screening period after signing the informed consent form;
•The subject is able to discontinue Short acting Beta agonists (SABA) for at least 6 hours and Short acting Anticholinergic Agents (SAMA) for at least 8 hours;
•Smoking history ≥ 10 pack years (pack years: number of packs per day multiplied by smoking years);
•There is no evidence to suggest active respiratory and/or cardiovascular diseases other than COPD in clinical practice (such as uncontrolled hypertension);
•No other related lung diseases or history of thoracic surgery;
•The subjects were able to undergo reproducible FEV1 lung function testing according to the the American Thoracic Society and the European Respiratory Society (ATS/ERS) 2005 standard during screening;
•Body mass index (BMI) is between 18-30kg/m2;

Exclusion Criteria

•History or current clinical instability of heart, respiratory, endocrine, metabolic, renal, liver, gastrointestinal, skin, infection, blood system, nervous system, or neurological/psychiatric disorders/abnormalities;
•The result of the human immunodeficiency virus (HIV) antibody test is positive; The result of hepatitis B surface antigen (HBsAg) test is positive (if HBsAg is positive, Hepatitis B virus deoxyribonucleic acid (HBV-DNA) should be checked if necessary, and if HBV-DNA\<Lower Limit of Quantification (LLOQ), it does not need to be excluded); Hepatitis C virus (HCV) antibody positive and confirmed presence of HCV ribonucleic acid (RNA); Positive for Treponema pallidum antibody (TPPA);
•Have a history of illegal drug abuse in the past;
•Have participated in other clinical trials and received the investigational drug within 3 months prior to participating in this trial, or within 5 half lives of the investigational drug, whichever is shorter;
•Those who have lost blood or donated more than 400 mL of blood within 2 months before the experiment;
•Have any clear and severe history of drug or food allergies, especially those who are allergic to ingredients similar to the investigational drug;
•Drinking history (drinking 14 units of alcohol per week: 1 unit=285 ml of beer; or 25 ml of spirits; or 1 glass of wine);
•History of malignant tumors in any organ system within the past 5 years, regardless of whether treatment has been received or not, except for local basal cell carcinoma of the skin;
•Lower respiratory tract infection occurred within 6 weeks before screening or randomization. Upper respiratory tract infections requiring antibiotics within 6 weeks prior to screening or randomization;
•Have a history of active tuberculosis, bronchiectasis, asthma or other non-specific lung diseases.