Phase I Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetic Profile of TQC3302 Inhalation Spray in Healthy Adult Subjects in China
概览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- Chia Tai Tianqing Pharmaceutical (Guangzhou) Co., Ltd.
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Treatment Emergent Adverse Event
概览
简要总结
Groups 1, 3, 4, 5 and 6 of this research team adopted a single-center, open-label design. Group 2 used a three-sequence, three-period crossover design, where participants in this dose group were randomly assigned to the three sequences in a 1:1:1 ratio to undergo three-period crossover administration. Healthy adult subjects were selected to use TQC3302 inhalation spray to evaluate the safety, tolerability, and pharmacokinetic characteristics of single and multiple inhalations of TQC3302 inhalation spray in healthy participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects voluntarily joined the study, sign informed consent form before the study and fully understand the study content
- •Healthy subjects aged between 18 and 55 years (inclusive),both male and female
- •The male subject should weigh at least 50kg, the female subject should weigh at least 45kg. And body mass index (BMI) within 19\~28 kg/m2
- •Inhalation administration training qualified.
- •During the screening period, the percentage of predicted value for forced expiratory volume in one second (FEV1) before bronchodilator administration is ≥80%, and FEV1/forced vital capacity (FVC) is ≥70%.
- •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
- •Individuals with a history of glaucoma, functional constipation, benign prostatic hyperplasia, urinary tract obstruction, etc
- •Current history of active tuberculosis, bronchiectasis or other non-specific lung diseases
- •People who have received or are planning to receive inactive or active vaccines during the 30 days prior to the screening period and the entire study period
- •Any history of drug allergies, Individuals with a specific history of allergies or allergies
- •Had undergone surgery within 1 month prior to screening period or expected to undergo surgery during the study period
- •People with special dietary requirements who cannot follow a standard diet;
- •People who have potential difficulty in blood collection, or have a history of halo needles or blood sickness；
- •History of drug or narcotics abuse or a positive result of urine drug test at screening
- •People who have abnormal and clinically significant results in vital signs, physical examination, laboratory tests, Chest radiograph and abdominal ultrasound during screening period
- •Subjects Positive for Any of Hepatitis B Virus Surface Antigen (HBsAg), Hepatitis C Virus Antibody (Anti-HCV), Human Immunodeficiency Virus Antibody (Anti-HIV), and Treponema Pallidum Antibody (Anti-TP)
研究组 & 干预措施
TQC3302 inhalation spray (50/2.5/2.5μg)
Administered as a single dose
干预措施: TQC3302 inhalation spray (Drug)
TQC3302 inhalation spray (200/5/5μg)-single dose
TQC3302 inhalation spray is administered as a single dose.
干预措施: TQC3302 inhalation spray (Drug)
TQC3302 inhalation spray (200/5/5μg)
Single dose during Day 1-Day 7
干预措施: TQC3302 inhalation spray (Drug)
TQC3302/Spiolto® Respimat® /Pulmicort®
Each drug is administered as a single dose.
TQC3302 inhalation spray (200/2.5/2.5μg); Spiolto® Respimat® : Tiotropium bromide and olodaterol hydrochloride inhalation spray (2.5/2.5μg); Pulmicort® : Budesonide Powder for Inhalation (200μg)
干预措施: TQC3302 inhalation spray+Tiotropium bromide and olodaterol hydrochloride inhalation spray +Budesonide Powder for Inhalation (Drug)
Pulmicort®/Spiolto® Respimat®
Each drug is administered as a single dose.
Spiolto® Respimat®: Tiotropium bromide and olodaterol hydrochloride inhalation spray (2.5/2.5μg) ; Pulmicort®: Budesonide Powder for Inhalation (200μg) TQC3302 inhalation spray (200/2.5/2.5μg)
干预措施: Tiotropium bromide and olodaterol hydrochloride inhalation spray +Budesonide Powder for Inhalation+ TQC3302 inhalation spray (Drug)
Spiolto® Respimat® /Pulmicort®/TQC3302
Each drug is administered as a single dose.
Pulmicort®: Budesonide Powder for Inhalation (200μg); TQC3302 inhalation spray (200/2.5/2.5μg); Spiolto® Respimat®: Tiotropium bromide and olodaterol hydrochloride inhalation spray (2.5/2.5μg)
干预措施: Budesonide Powder for Inhalation+ TQC3302 inhalation spray+ Tiotropium bromide and olodaterol hydrochloride inhalation spray (Drug)
TQC3302 inhalation spray (400/5/5μg)
TQC3302 inhalation spray is administered as a single dose
干预措施: TQC3302 inhalation spray (Drug)
TQC3302 inhalation spray (400/5/5μg)-single dose
single dose during Day 1-Day 7
干预措施: TQC3302 inhalation spray (Drug)
TQC3302 inhalation spray (400/5/5μg) -two dose
Two dose during Day 1-Day 7
干预措施: TQC3302 inhalation spray (Drug)
结局指标
主要结局
Treatment Emergent Adverse Event
时间窗: From the use of the investigational drug until the last study visit, up to Day 14
The incidence and severity of adverse events after treatment From the use of the investigational drug until the last study visit.
The subject with abnormal security check
时间窗: From the use of the investigational drug until the last study visit, up to Day 14
The frequency, incidence, and severity of laboratory tests, vital signs, physical examinations, electrocardiogram examinations, etc.
次要结局
- Cmax after dose(Single dose：pre-dose, at 2,5,8,12,25,45 minutes,1,2,4,8,12,24, 48,72,120 hours after-dose (When using Budesonide Powder for Inhalation, there is no need to monitor at 48, 72, and 120 hours after the end of administration))
- Area Under the Concentration-Time Curve From 0 to Last Observation (AUC [0-t])(Multiple dosing: at 2, 5, 8, 12, 25, 45 minutes, 1, 2, 4, 8, 12, 24 hours after the first dose, before Day 5, 6, 7, at 2, 5, 8,1 2, 25, 45 minutes, 1, 2 , 4, 8, 12, 24, 48, 72, 120 hours after Day 7 dose)
- Area Under the Concentration-Time Curve From Zero to Infinity (AUC [0-infinity])(Multiple dosing: at 2, 5, 8, 12, 25, 45 minutes, 1, 2, 4, 8, 12, 24 hours after the first dose, before Day 5, 6, 7, at 2, 5, 8,1 2, 25, 45 minutes, 1, 2 , 4, 8, 12, 24, 48, 72, 120 hours after Day 7 dose)
- Time to reach maximum (peak) plasma concentration following drug administration (Tmax)(Single dose：pre-dose, at 2,5,8,12,25,45 minutes,1,2,4,8,12,24, 48,72,120 hours after-dose (When using Budesonide Powder for Inhalation, there is no need to monitor at 48, 72, and 120 hours after the end of administration))
- Half-life (t1/2)(Single dose：pre-dose, at 2,5,8,12,25,45 minutes,1,2,4,8,12,24, 48,72,120 hours after-dose (When using Budesonide Powder for Inhalation, there is no need to monitor at 48, 72, and 120 hours after the end of administration))
- Apparent volume of distribution (Vd/F)(Single dose：pre-dose, at 2,5,8,12,25,45 minutes,1,2,4,8,12,24, 48,72,120 hours after-dose (When using Budesonide Powder for Inhalation, there is no need to monitor at 48, 72, and 120 hours after the end of administration))
- Apparent clearance (CL/F)(Single dose：pre-dose, at 2,5,8,12,25,45 minutes,1,2,4,8,12,24, 48,72,120 hours after-dose (When using Budesonide Powder for Inhalation, there is no need to monitor at 48, 72, and 120 hours after the end of administration))
- Peak concentration (Cmax) after the first administration(Multiple dosing: at 2, 5, 8, 12, 25, 45 minutes, 1, 2, 4, 8, 12 hours after the first administration)
- Time to reach maximum (peak) plasma concentration after the first administration (Tmax)(Multiple dosing: at 2, 5, 8, 12, 25, 45 minutes, 1, 2, 4, 8, 12 hours after the first administration)
- Half-life after the first administration(Multiple dosing: at 2, 5, 8, 12, 25, 45 minutes, 1, 2, 4, 8, 12 hours after the first administration)
- Area Under the Concentration-Time Curve From 0 to Last Observation after the first administration(Multiple dosing: at 2, 5, 8, 12, 25, 45 minutes, 1, 2, 4, 8, 12 hours after the first administration)
- Area Under the Concentration-Time Curve From Zero to Infinity after the first administration(Multiple dosing: at 2, 5, 8, 12, 25, 45 minutes, 1, 2, 4, 8, 12 hours after the first administration)
- Peak concentration (Cmax)(Multiple dosing: at 2, 5, 8, 12, 25, 45 minutes, 1, 2, 4, 8, 12, 24 hours after the first dose, before Day 5, 6, 7, at 2, 5, 8,1 2, 25, 45 minutes, 1, 2 , 4, 8, 12, 24, 48, 72, 120 hours after Day 7 dose)
- Time to reach maximum (peak) plasma concentration following drug administration(Multiple dosing: at 2, 5, 8, 12, 25, 45 minutes, 1, 2, 4, 8, 12, 24 hours after the first dose, before Day 5, 6, 7, at 2, 5, 8,1 2, 25, 45 minutes, 1, 2 , 4, 8, 12, 24, 48, 72, 120 hours after Day 7 dose)
- Area Under the Concentration-Time Profile From Time Zero to the Dosing Interval Tau(Multiple dosing: at 2, 5, 8, 12, 25, 45 minutes, 1, 2, 4, 8, 12, 24 hours after the first dose, before Day 5, 6, 7, at 2, 5, 8,1 2, 25, 45 minutes, 1, 2 , 4, 8, 12, 24, 48, 72, 120 hours after Day 7 dose)
- Half-life (t1/2): Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma(Multiple dosing: at 2, 5, 8, 12, 25, 45 minutes, 1, 2, 4, 8, 12, 24 hours after the first dose, before Day 5, 6, 7, at 2, 5, 8,1 2, 25, 45 minutes, 1, 2 , 4, 8, 12, 24, 48, 72, 120 hours after Day 7 dose)
- Accumulation ratio based on peak concentration (Rac (Cmax))(Multiple dosing: at 2, 5, 8, 12, 25, 45 minutes, 1, 2, 4, 8, 12, 24 hours after the first dose, before Day 5, 6, 7, at 2, 5, 8,1 2, 25, 45 minutes, 1, 2 , 4, 8, 12, 24, 48, 72, 120 hours after Day 7 dose)
- Accumulation ratio based on AUC(Multiple dosing: at 2, 5, 8, 12, 25, 45 minutes, 1, 2, 4, 8, 12, 24 hours after the first dose, before Day 5, 6, 7, at 2, 5, 8,1 2, 25, 45 minutes, 1, 2 , 4, 8, 12, 24, 48, 72, 120 hours after Day 7 dose)
- Area Under the Concentration-Time Curve From 0 to Last Observation (AUC [0-t])(Single dose：pre-dose, at 2,5,8,12,25,45 minutes,1,2,4,8,12,24, 48,72,120 hours after-dose (When using Budesonide Powder for Inhalation, there is no need to monitor at 48, 72, and 120 hours after the end of administration))
- Area Under the Concentration-Time Curve From Zero to Infinity (AUC [0-infinity])(Single dose：pre-dose, at 2,5,8,12,25,45 minutes,1,2,4,8,12,24, 48,72,120 hours after-dose (When using Budesonide Powder for Inhalation, there is no need to monitor at 48, 72, and 120 hours after the end of administration))