NCT06711991CompletedPhase 1
A Clinical Trial of TQC3927 Powder for Inhalation in Chronic Obstructive Pulmonary Disease
A Phase I Clinical Study on the Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Characteristics of Single/Multiple Dose Escalation of TQC3927 Inhalation Powder in Patients With Chronic Obstructive Pulmonary Disease
Source: ClinicalTrials.gov · Last updated 15 Aug 2025
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 48 (actual)
- First submitted
- 22 Nov 2024
- Start date
- 11 Feb 2025
- Primary completion date
- 11 Aug 2025
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Diseases
- COPD
- NCT number
- NCT06711991
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 48
- From 11 Feb 2025 to the primary completion date, 11 Aug 2025
- 7 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participated in other clinical trials and received research interventions in the 3 months prior to participating in this trial
- 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
- 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
Other illness
- 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)
Other
- Screening for individuals who have used biologics within the past 3 months
- 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
Who the study is looking for
- 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)
Age in the registry: 40 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Aerospace center hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| China-Japan Friendship Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| The Third People Hospital of Chengdu Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| Heze Municipal Hospital Coordinator of this site? Confirm its status | Heze | China | Unknown status |
| The First Affiliated Hospital of NanChang University Coordinator of this site? Confirm its status | Nanchang | China | Unknown status |
| The Second Affiliated Hospital of Wenzhou Medical University Coordinator of this site? Confirm its status | Wenzhou | China | Unknown status |
| Zibo Municipal Hospital Coordinator of this site? Confirm its status | Zibo | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.