NCT06748079已完成1 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 113
- 试验地点
- 1
- 主要终点
- Adverse events (AE)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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;
- •4.1Applicable to Part 1: 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; 4.2 Applicable to Part 2: Being able to adjust the current COPD treatment or for COPD patients with initial treatment,LAMA inhaled drugs can be used during the lead-in period after signing the informed consent form;
- •5.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; 6.Smoking history ≥ 10 pack years (pack years: number of packs per day multiplied by smoking years); 7.There is no evidence to suggest active respiratory and/or cardiovascular diseases other than COPD in clinical practice (such as uncontrolled hypertension); 8.No other related lung diseases or history of thoracic surgery; 9.The subjects were able to undergo reproducible FEV1 lung function testing according to the ATS/ERS 2005 standard during screening;
- •Body mass index (BMI) is between 18-30kg/m2; 11.Participants must agree to use contraceptive methods (such as birth control pills, condoms, or intrauterine devices) with sexual partners of childbearing age during the clinical trial period (screening period to 30 days after the last dose); 12) The subject is able to use a dry powder inhaler correctly for inhalation. 13) I have fully understood this study and voluntarily participated. I have signed the 'Informed Consent Form'.
排除标准
- •1 . History or current clinical instability of heart, respiratory, endocrine, metabolic, renal, liver, gastrointestinal, skin, infection, blood system, nervous system, or neurological/psychiatric disorders/abnormalities; 2. 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\450ms, female\>470ms, or history of long QT syndrome before screening or randomization; 12. Subjects with a history of drug use in the past 2 years; 13. Subjects who are unable to comply with past medication and concomitant medication restrictions; 14. If there is a history of acute exacerbation of COPD within 3 months before screening or randomization, hospitalization or additional COPD maintenance treatment is required. Over the past three years, the average number of frequent exacerbations of COPD with moderate to severe severity has been ≥ 2 per year, or resulting in hospitalization for ≥ 2 acute exacerbations per year; 15. Oral non selective beta blockers; 16. Previously treated with TQC3721 suspension. 17. Any situation that researchers believe may pose safety risks to subjects in the trial or may interfere with the conduct of this study, or where researchers believe that subjects may not be able to complete this study or may not be able to comply with the requirements of this study (due to management or other reasons).
研究组 & 干预措施
Placebo for TQC3721 inhalation powder
Placebo Comparator
Placebo for TQC3721 inhalation powder inhalation is administered as a single dose or continuously for 7 days.
干预措施: Placebo for TQC3721 inhalation powder (Drug)
TQC3721 inhalation powder
Experimental
TQC3721 inhalation powder is administered as a single dose or continuously for 7 days.
干预措施: TQC3721 inhalation powder (Drug)
TQC3721 Inhaler Powder + Glimetrexate Inhaler Powder / Control Group
Experimental
TQC3721 inhalation powder combined with glyberlam inhalation powder or a control group for 14 consecutive days of inhalation administration.
干预措施: TQC3721 inhalation powder combined with glyberlam inhalation powder or a control group (Drug)
结局指标
主要结局
Adverse events (AE)
时间窗: 21 days
Incidence of adverse events (AE)
Serious Adverse Events (SAE)
时间窗: 21 days
Incidence of Serious Adverse Events (SAE)
Treatment-emergent adverse events (TEAEs)
时间窗: 19 days
Incidence of treatment-emergent adverse events (TEAEs)
次要结局
- PD indices: Pulmonary function test parameters(From D-1 to End of Treatment(EOT).)
- Serum and sputum inflammatory cells(From D-1 to D11 or End of EOT))
- Plasma drug peak concentration(9 days)
- COPD Assessment Tes (CAT) scores(From day 1 to day 11 or end of treatment, whichever came first)
研究者
研究点 (1)
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