Status:
RECRUITING
A Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetic Profile of TQC3302 Inhalation Spray in Healthy Adult Subjects
Lead Sponsor:
Chia Tai Tianqing Pharmaceutical (Guangzhou) Co., Ltd.
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
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 rando...
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
Key Trial Info
Start Date :
November 25 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT07267130
Start Date
November 25 2025
End Date
December 1 2026
Last Update
March 10 2026
Active Locations (1)
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1
China Japan Friendship Hospital Beijing
Beijing, Beijing Municipality, China, 100000