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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Page 1 of 1 (1 locations)

1

China Japan Friendship Hospital Beijing

Beijing, Beijing Municipality, China, 100000