A Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetic Profile of TQC3302 Inhalation Spray in Healthy Adult Subjects

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorChia Tai Tianqing Pharmaceutical (Guangzhou) Co., Ltd.

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • TQC3302 inhalation spray
  • TQC3302 inhalation spray+Tiotropium bromide and olodaterol hydrochloride inhalation spray +Budesonide Powder for Inhalation
  • Tiotropium bromide and olodaterol hydrochloride inhalation spray +Budesonide Powder for Inhalation+ TQC3302 inhalation spray
  • Budesonide Powder for Inhalation+ TQC3302 inhalation spray+ Tiotropium bromide and olodaterol hydrochloride inhalation spray
  • TQC3302 inhalation spray

Treatment groups

57 Participants
are divided into 9 treatment groups

9

Treatment groups

See each treatment group below.