RecruitingPhase 1NCT06748079

A Clinical Study of TQC3721 Inhalation Powder in Patients With Chronic Obstructive Pulmonary Disease

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


Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Enrollment

72 participants

Start Date

Dec 3, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 40 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new inhaled powder medication called TQC3721 in people with moderate to severe chronic obstructive pulmonary disease (COPD) — a lung disease that makes it hard to breathe. The study aims to see how well the medication improves breathing compared to existing treatments. **You may be eligible if...** - You are between 40 and 75 years old - You have been diagnosed with stable, moderate to severe COPD based on standard breathing tests - Your breathing test shows that you have limited airflow (FEV1/FVC below 0.7, and FEV1 between 40% and 80% of predicted) - Your airways show some ability to open up after using a bronchodilator (a breathing-relief drug) - You are currently on or willing to switch to bronchodilator inhalers for COPD **You may NOT be eligible if...** - You have very severe COPD (FEV1 below 40% of predicted) - You have had a COPD flare-up or used oral steroids recently - You have significant other lung conditions (such as asthma, active tuberculosis, or lung cancer) - You are pregnant or planning to become pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTQC3721 inhalation powder

TQC3721 is a target inhibitor.

DRUGPlacebo for TQC3721 inhalation powder

Placebo without drug substance.


Locations(1)

West China Hospital of Sichuan University

Chengdu, Sichuan, China

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NCT06748079


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