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

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

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

Secondary outcome measures (12)

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

Eligibility criteria

Inclusion criteria

• 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)

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Crossover

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• China Japan Friendship Hospital Beijing — Beijing

Identifiers

NCT: NCT07267130 · TQC3302-I-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗