A Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetic Profile of TQC3302 Inhalation Spray in Healthy Adult Subjects
Recruiting · NCT07267130 · Interventional (participants receive a specific treatment) · Lead sponsor: Chia Tai Tianqing Pharmaceutical (Guangzhou) Co., Ltd.
View the official record on ClinicalTrials.gov →Interventions studied
Budesonide Powder for Inhalation+ TQC3302 inhalation spray+ Tiotropium bromide and olodaterol hydrochloride inhalation sprayTQC3302 inhalation sprayTQC3302 inhalation spray+Tiotropium bromide and olodaterol hydrochloride inhalation spray +Budesonide Powder for InhalationTiotropium bromide and olodaterol hydrochloride inhalation spray +Budesonide Powder for Inhalation+ TQC3302 inhalation spray
What this trial is about
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.
Who can take part
Age range
18 Years to 55 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- China Japan Friendship Hospital Beijing - Beijing, Beijing Municipality, China