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حالة التجربة السريرية NCT07267130 لـ مرض الانسداد الرئوي المزمن هي يقبل مشاركين. اطلعوا على جميع التفاصيل في عرض البطاقة الخاص برادار التجارب السريرية وأدوات اكتشاف الذكاء الاصطناعي. أو يمكنكم طرح أي سؤال هنا. | ||
تجربة واحدة تطابق معايير الفلتر
عرض البطاقة
A Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetic Profile of TQC3302 Inhalation Spray in Healthy Adult Subjects المرحلة الأولى ٥٧ تصميم متقاطع تجربة مفتوحة
تفاصيل التجربة السريرية متاحة بشكل أساسي باللغة الإنجليزية. ومع ذلك، يمكن لـ رادار التجارب AI مساعدتك؛ ما عليك سوى النقر على «وصف الدراسة» لعرض ومناقشة معلومات التجربة باللغة التي اخترتها.
التجربة السريرية NCT07267130 مصممة لدراسة علاج لـمرض الانسداد الرئوي المزمن. إنها تجربة تدخُّلية من المرحلة الأولى وهي يقبل مشاركين. بدأت في ٤ جمادى الآخرة ١٤٤٧ هـ مع خطة لتجنيد ٥٧ مشاركًا. تقودها Chia Tai Tianqing Pharmaceutical (Guangzhou) Co., Ltd.، ومن المتوقع اكتمالها بحلول ٢١ جمادى الآخرة ١٤٤٨ هـ. تم تحديث البيانات الأخيرة من ClinicalTrials.gov في ٢١ رمضان ١٤٤٧ هـ.
الملخص
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 pharma...عرض المزيد
العنوان الرسمي
Phase I Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetic Profile of TQC3302 Inhalation Spray in Healthy Adult Subjects in China
الحالات الطبية
مرض الانسداد الرئوي المزمنمعرّفات دراسة أخرى
- TQC3302-I-01
NCT معرّف
تاريخ البدء (فعلي)
2025-11-25
آخر تحديث مُنشور
2026-03-10
تاريخ الاكتمال (المقدر)
2026-12
عدد المشاركين المخطط لهم
٥٧
نوع الدراسة
تدخُّلية
المرحلة
المرحلة الأولى
الحالة
يقبل مشاركين
الغرض الأساسي
العلاج
طريقة توزيع المشاركين
عشوائي
نموذج التدخل
تصميم متقاطع
التعمية
لا شيء (تجربة مفتوحة)
مجموعات/التدخلات
| مجموعة المشاركين/الذراع | التدخل/العلاج |
|---|---|
تجريبيةTQC3302 inhalation spray (50/2.5/2.5μg) Administered as a single dose | TQC3302 inhalation spray TQC3302 inhalation spray is a targeted inhibitor |
تجريبيةTQC3302/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) | TQC3302 inhalation spray+Tiotropium bromide and olodaterol hydrochloride inhalation spray +Budesonide Powder for Inhalation TQC3302 inhalation spray is a targeted inhibitor, Tiotropium bromide and olodaterol hydrochloride inhalation spray is a targeted inhibitor, Budesonide Powder for Inhalation is a Inhaled Corticosteroids. |
تجريبيةPulmicort®/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) | Tiotropium bromide and olodaterol hydrochloride inhalation spray +Budesonide Powder for Inhalation+ TQC3302 inhalation spray TQC3302 inhalation spray is a targeted inhibitor, Tiotropium bromide and olodaterol hydrochloride inhalation spray is a targeted inhibitor, Budesonide Powder for Inhalation is a Inhaled Corticosteroids. |
تجريبيةSpiolto® 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) | Budesonide Powder for Inhalation+ TQC3302 inhalation spray+ Tiotropium bromide and olodaterol hydrochloride inhalation spray TQC3302 inhalation spray is a targeted inhibitor, Tiotropium bromide and olodaterol hydrochloride inhalation spray is a targeted inhibitor, Budesonide Powder for Inhalation is a Inhaled Corticosteroids. |
تجريبيةTQC3302 inhalation spray (200/5/5μg)-single dose TQC3302 inhalation spray is administered as a single dose. | TQC3302 inhalation spray TQC3302 inhalation spray is a targeted inhibitor |
تجريبيةTQC3302 inhalation spray (400/5/5μg) TQC3302 inhalation spray is administered as a single dose | TQC3302 inhalation spray TQC3302 inhalation spray is a targeted inhibitor |
تجريبيةTQC3302 inhalation spray (200/5/5μg) Single dose during Day 1-Day 7 | TQC3302 inhalation spray TQC3302 inhalation spray is a targeted inhibitor |
تجريبيةTQC3302 inhalation spray (400/5/5μg)-single dose single dose during Day 1-Day 7 | TQC3302 inhalation spray TQC3302 inhalation spray is a targeted inhibitor |
تجريبيةTQC3302 inhalation spray (400/5/5μg) -two dose Two dose during Day 1-Day 7 | TQC3302 inhalation spray TQC3302 inhalation spray is a targeted inhibitor |
النتيجة الرئيسية
النتيجة الثانوية
| مقياس النتيجة | وصف القياس | الإطار الزمني |
|---|---|---|
Treatment Emergent Adverse Event | The incidence and severity of adverse events after treatment From the use of the investigational drug until the last study visit. | From the use of the investigational drug until the last study visit, up to Day 14 |
The subject with abnormal security check | The frequency, incidence, and severity of laboratory tests, vital signs, physical examinations, electrocardiogram examinations, etc. | From the use of the investigational drug until the last study visit, up to Day 14 |
| مقياس النتيجة | وصف القياس | الإطار الزمني |
|---|---|---|
Cmax after dose | The Cmax is the maximum observed plasma concentration of study drug | 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]) | To characterize the pharmacokinetics of TQC3302 by assessment of area under the plasma concentration time curve from the first dose to a certain time point | 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]) | To characterize the pharmacokinetics of TQC3302 by assessment of area under the plasma concentration time curve from 0 extrapolated to 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) |
Time to reach maximum (peak) plasma concentration following drug administration (Tmax) | To characterize the pharmacokinetics of TQC3302 by assessment of time to reach maximum plasma concentration after single dosing. | 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) | Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma. | 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) | Apparent volume of distribution of the TQC3302 in plasma. | 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) | Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the body. | 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 | The Cmax is the maximum observed plasma concentration of study drug. | 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) | To characterize the pharmacokinetics of TQC3302 by assessment of time to reach maximum plasma concentration after the first administration. | 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 | 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 hours after the first administration |
Area Under the Concentration-Time Curve From 0 to Last Observation after the first administration | To characterize the pharmacokinetics of TQC3302 by assessment of area under the plasma concentration time curve from the first dose to a certain time point. | 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 | To characterize the pharmacokinetics of TQC3302 by assessment of area under the plasma concentration time curve from 0 extrapolated to infinity | Multiple dosing: at 2, 5, 8, 12, 25, 45 minutes, 1, 2, 4, 8, 12 hours after the first administration |
Peak concentration (Cmax) | The Cmax is the maximum observed plasma concentration of study drug | 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 | To characterize the pharmacokinetics of TQC3302 by assessment of time to reach maximum plasma concentration after multiple dosing | 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]) | To characterize the pharmacokinetics of TQC3302 by assessment of area under the plasma concentration time curve from the first dose to a certain time point | 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]) | To characterize the pharmacokinetics of TQC3302 by assessment of area under the plasma concentration time curve from 0 extrapolated to 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 |
Area Under the Concentration-Time Profile From Time Zero to the Dosing Interval Tau | Area Under the Concentration-Time Profile From Time Zero to the Dosing Interval Tau (AUCtau) of TQC3302 from the first dose to a certain time point. | 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 | 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)) | 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 | 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 |
مساعد المشاركة
معايير الأهلية
الأعمار المؤهلة للدراسة
بالغ
العمر الأدنى للدراسة
18 Years
الجنس المؤهل
الكل
يقبل المتطوعين الأصحاء
نعم
- 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)
- 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)
- Pregnant or lactating women or those with positive blood pregnancy test results during the screening period
Chia Tai Tianqing Pharmaceutical (Guangzhou) Co., Ltd.جهة اتصال مركزية للدراسة
جهة اتصال: Jintong Li, Doctor, 15300059186, [email protected]
1 مواقع الدراسة في 1 بلدان
Beijing Municipality
China Japan Friendship Hospital Beijing, Beijing, Beijing Municipality, 100000, China
Jintong Li, Doctor, جهة اتصال, 15300059186, [email protected]
يقبل مشاركين