Actively Recruiting
A Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetic Profile of TQC3302 Inhalation Spray in Healthy Adult Subjects
Led by Chia Tai Tianqing Pharmaceutical (Guangzhou) Co., Ltd. · Updated on 2026-03-10
57
Participants Needed
1
Research Sites
53 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Official Title
A Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetic Profile of TQC3302 Inhalation Spray in Healthy Adult Subjects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
- Male subjects should weigh at least 50 kg, female subjects should weigh at least 45 kg
- Body mass index (BMI) within 19 to 28 kg/m2
- Qualified in inhalation administration training
- During screening, predicted forced expiratory volume in one second (FEV1) before bronchodilator is at least 80%, and FEV1/forced vital capacity (FVC) is at least 70%
- No pregnancy plan and voluntarily take effective contraception measures from screening to 90 days after last dose (subjects and their partners)
You will not qualify if you...
- History of glaucoma, functional constipation, benign prostatic hyperplasia, urinary tract obstruction
- Current active tuberculosis, bronchiectasis, or other non-specific lung diseases
- Received or planning to receive inactive or active vaccines 30 days before screening and during study
- History of drug allergies or specific allergies
- Surgery within 1 month prior to screening or planned during the study
- Special dietary requirements preventing standard diet
- Potential difficulty in blood collection or history of halo needles or blood sickness
- History of drug or narcotics abuse or positive urine drug test at screening
- Abnormal and clinically significant vital signs, physical exam, laboratory tests, chest radiograph, or abdominal ultrasound during screening
- Positive for Hepatitis B Virus Surface Antigen, Hepatitis C Virus Antibody, HIV Antibody, or Treponema Pallidum Antibody
- Pregnant or lactating women or positive pregnancy test during screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
China Japan Friendship Hospital Beijing
Beijing, Beijing Municipality, China, 100000
Actively Recruiting
Research Team
J
Jintong Li, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
9
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