A Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetic Profile of TQC3302 Inhalation Spray in Healthy Adult Subjects

Официальное название

Phase I Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetic Profile of TQC3302 Inhalation Spray in Healthy Adult Subjects in China

Обзор

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.

Вмешательства

• Препарат TQC3302 inhalation spray
  TQC3302 inhalation spray is a targeted inhibitor
• Препарат 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.
• Препарат 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.
• Препарат 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.
• Препарат TQC3302 inhalation spray
  TQC3302 inhalation spray is a targeted inhibitor

Первичные конечные точки

• Treatment Emergent Adverse Event [Срок оценки: From the use of the investigational drug until the last study visit, up to Day 14]
• The subject with abnormal security check [Срок оценки: From the use of the investigational drug until the last study visit, up to Day 14]

Вторичные конечные точки (12)

• Cmax after dose [Срок оценки: 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]) [Срок оценки: 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]) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Multiple dosing: at 2, 5, 8, 12, 25, 45 minutes, 1, 2, 4, 8, 12 hours after the first administration]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• China Japan Friendship Hospital Beijing — Пекин

Идентификаторы

NCT: NCT07267130 · TQC3302-I-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗