Actively Recruiting
Phase I Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetic Profile of TQC3302 Inhalation Spray in Healthy Adult Subjects in China
Led by Chia Tai Tianqing Pharmaceutical (Guangzhou) Co., Ltd. · Updated on 2026-03-10
57
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and how the body processes TQC3302 inhalation spray in healthy adults between 18 and 55 years old. This Phase 1 clinical study uses both a single-center, open-label design and a randomized three-sequence, three-period crossover design for different groups. The study focuses on measuring adverse events and drug levels in the body after single and multiple inhalations of TQC3302 and comparator inhalation sprays in healthy participants. Participants receive single doses or multiple doses of TQC3302 inhalation spray alone or combined with other inhaled drugs like Tiotropium bromide and olodaterol hydrochloride inhalation spray or Budesonide Powder for Inhalation. Different dosing schedules cover single doses during days 1 to 7 and two doses during this period. The study groups are randomized to receive these treatments in various sequences to compare safety and pharmacokinetic profiles. During the study, participants undergo detailed safety assessments including monitoring for side effects up to day 14 after dosing. Blood samples are collected at multiple time points to measure drug concentrations and pharmacokinetic parameters like peak concentration, clearance, and half-life. The study also includes physical exams, lung function tests, laboratory tests, chest X-rays, and ultrasound evaluations during screening. The total participation spans from screening through follow-up visits up to 14 days after the last dose.
CONDITIONS
Brief 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, signed informed consent, and fully understood the study content
- Healthy adults aged 18 to 55 years, both male and female
- Males weighing at least 50 kg, females weighing at least 45 kg, with BMI between 19 and 28 kg/m2
- Qualified in inhalation administration training
- Lung function with FEV1 ≥80% predicted and FEV1/FVC ≥70% at screening
- No pregnancy plan and agreement to use effective contraception from screening to 90 days after last dose (participants and partners)
You will not qualify if you...
- History of glaucoma, functional constipation, benign prostatic hyperplasia, or urinary tract obstruction
- Current active tuberculosis, bronchiectasis, or other non-specific lung diseases
- Received or planning to receive vaccines within 30 days prior to screening or during study
- History of drug allergies or specific allergies
- Surgery within 1 month before screening or planned during study
- Special dietary requirements preventing standard diet
- Difficulty with blood collection or history of needle-related issues
- History of drug or narcotics abuse or positive urine drug test at screening
- Abnormal or clinically significant vital signs, physical exam, lab tests, chest X-ray, or abdominal ultrasound during screening
- Positive for hepatitis B surface antigen, hepatitis C antibody, HIV antibody, or syphilis antibody
- Pregnant or lactating women or positive pregnancy test at screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 7 days
Participants receive single or multiple doses of different inhalation sprays including TQC3302 and combination therapies in a randomized crossover design to evaluate safety, tolerability, and pharmacokinetics.
Multiple visits for dosing and monitoring during up to 7 days
Duration - Up to Day 14 after last dose
Participants are monitored for adverse events and pharmacokinetic outcomes up to 14 days after the last dose.
Follow-up visits for safety and pharmacokinetic assessments up to Day 14
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
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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