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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 7
- 主要终点
- Adverse events (AE)
研究概览
简要总结
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
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
TQC3927 powder for inhalation
TQC3927 powder for inhalation is administered as a single administration for 1 day and continuous administration for 6 days.
干预措施: TQC3927 powder for inhalation (Drug)
TQC3927 powder for inhalation placebo
TQC3927 powder for inhalation placebo is administered as a single administration for 1 day and continuous administration for 6 days.
干预措施: TQC3927 powder for inhalation placebo (Drug)
结局指标
主要结局
Adverse events (AE)
时间窗: From the use of the investigational drug until the last study visit, up to day 16
The occurrence of all adverse events (AE) including abnormal laboratory test indicators.
Serious adverse events (SAE)
时间窗: From the use of the investigational drug until the last study visit, up to day 16
The occurrence of all serious adverse events (SAE) .
Forced expiratory volume (FEV1) trough value changed from baseline
时间窗: After administration of Day1 and Day7，before administration of Day3 and Day5
After administration of Day1 and Day7, the FEV1 trough value changed from baseline. The changes in FEV1 before administration of Day3 and Day5 compared to baseline.
Forced vital capacity (FVC) changes compared to baseline
时间窗: After administration of Day1 and Day7，before administration of Day3 and Day5
FVC changes compared to baseline at each lung function visit point.
The peak FEV1 value changed from baseline
时间窗: After administration of Day1 and Day7，before administration of Day3 and Day5
After administration of Day1 and Day7, the peak FEV1 value changed from baseline.
The area under the FEV1 curve of the average change from baseline
时间窗: After administration of Day1 and Day7，before administration of Day3 and Day5
The area under the FEV1 curve of the average change from baseline after administration of D1 and D7 ranges from 0-6h (AUC0-6h), 0-12h (AUC0-12h), 12-24h (AUC12-24h), 0-24h (AUC0-24h), and FVC AUC (0-24h).
The change in chronic obstructive pulmonary disease (CAT) score from baseline
时间窗: After administration of Day1 and Day7，before administration of Day3 and Day5
The change in chronic obstructive pulmonary disease (CAT) score from baseline on the day after Day7 administration.
次要结局
- Peak concentration (Cmax)(Day1: pre-dose, at 15,30,45 minutes,1,2,4,6,8,12,24 hours after-dose, Day5: pre-dose, Day6: pre-dose, Day7: pre-dose, at 15,30,45 minutes,1,2,4,6,8,12,24,48,72 hours after-dose)
- Area Under the Concentration-Time Curve From 0 to Last Observation (AUC [0-t])(Day1: pre-dose, at 15,30,45 minutes,1,2,4,6,8,12,24 hours after-dose, Day5: pre-dose, Day6: pre-dose, Day7: pre-dose, at 15,30,45 minutes,1,2,4,6,8,12,24,48,72 hours after-dose)
- Area Under the Concentration-Time Curve From Zero to Infinity (AUC [0-infinity])(Day1: pre-dose, at 15,30,45 minutes,1,2,4,6,8,12,24 hours after-dose, Day5: pre-dose, Day6: pre-dose, Day7: pre-dose, at 15,30,45 minutes,1,2,4,6,8,12,24,48,72 hours after-dose)
- Time to reach maximum (peak) plasma concentration following drug administration (Tmax)(Day1: pre-dose, at 15,30,45 minutes,1,2,4,6,8,12,24 hours after-dose, Day5: pre-dose, Day6: pre-dose, Day7: pre-dose, at 15,30,45 minutes,1,2,4,6,8,12,24,48,72 hours after-dose)
- Half-life (t1/2)(Day1: pre-dose, at 15,30,45 minutes,1,2,4,6,8,12,24 hours after-dose, Day5: pre-dose, Day6: pre-dose, Day7: pre-dose, at 15,30,45 minutes,1,2,4,6,8,12,24,48,72 hours after-dose)
- Apparent volume of distribution(Vd/F)(Day1: pre-dose, at 15,30,45 minutes,1,2,4,6,8,12,24 hours after-dose, Day5: pre-dose, Day6: pre-dose, Day7: pre-dose, at 15,30,45 minutes,1,2,4,6,8,12,24,48,72 hours after-dose)
- Apparent clearance (CLz/F)(Day1: pre-dose, at 15,30,45 minutes,1,2,4,6,8,12,24 hours after-dose, Day5: pre-dose, Day6: pre-dose, Day7: pre-dose, at 15,30,45 minutes,1,2,4,6,8,12,24,48,72 hours after-dose)
- End elimination rate (λz)(Day1: pre-dose, at 15,30,45 minutes,1,2,4,6,8,12,24 hours after-dose, Day5: pre-dose, Day6: pre-dose, Day7: pre-dose, at 15,30,45 minutes,1,2,4,6,8,12,24,48,72 hours after-dose)
- Residual area percentage (AUC_%Extrap)(Day1: pre-dose, at 15,30,45 minutes,1,2,4,6,8,12,24 hours after-dose, Day5: pre-dose, Day6: pre-dose, Day7: pre-dose, at 15,30,45 minutes,1,2,4,6,8,12,24,48,72 hours after-dose)
- Average dwell time(MRT0-t)(Day1: pre-dose, at 15,30,45 minutes,1,2,4,6,8,12,24 hours after-dose, Day5: pre-dose, Day6: pre-dose, Day7: pre-dose, at 15,30,45 minutes,1,2,4,6,8,12,24,48,72 hours after-dose)
- Average dwell time(MRT0-∞)(Day1: pre-dose, at 15,30,45 minutes,1,2,4,6,8,12,24 hours after-dose, Day5: pre-dose, Day6: pre-dose, Day7: pre-dose, at 15,30,45 minutes,1,2,4,6,8,12,24,48,72 hours after-dose)