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

Chia Tai Tianqing Pharmaceutical (Guangzhou) Co., Ltd.

Status and phase

Enrolling

Phase 1

Conditions

Chronic Obstructive Pulmonary Disease

Treatments

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

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

Drug: TQC3302 inhalation spray

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

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT07267130

TQC3302-I-01

Details and patient eligibility

About

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.

Enrollment

44 estimated patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

44 participants in 8 patient groups

TQC3302 inhalation spray (50/2.5/2.5μg)

Experimental group

Description:

Administered as a single dose

Treatment:

Drug: TQC3302 inhalation spray

TQC3302/Spiolto® Respimat® /Pulmicort®

Experimental group

Description:

Each drug is administered as a single dose. TQC3302 inhalation spray (50/2.5/2.5μg); TQC3302 inhalation spray (100/2.5/2.5μg); Spiolto® Respimat® : Tiotropium bromide and olodaterol hydrochloride inhalation spray (2.5/2.5μg); Pulmicort® : Budesonide Powder for Inhalation (200μg)

Treatment:

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

TQC3302/Pulmicort®/Spiolto® Respimat®

Experimental group

Description:

Each drug is administered as a single dose. TQC3302 inhalation spray (100/2.5/2.5μg); Spiolto® Respimat®: Tiotropium bromide and olodaterol hydrochloride inhalation spray (2.5/2.5μg) ; Pulmicort®: Budesonide Powder for Inhalation (200μg) TQC3302 inhalation spray (50/2.5/2.5μg)

Treatment:

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

TQC3302/Spiolto® Respimat®/Pulmicort®

Experimental group

Description:

Each drug is administered as a single dose. Spiolto® Respimat®: Tiotropium bromide and olodaterol hydrochloride inhalation spray (2.5/2.5μg); Pulmicort® : Budesonide Powder for Inhalation (200μg); TQC3302 inhalation spray (50/2.5/2.5μg); TQC3302 inhalation spray (100/2.5/2.5μg)

Treatment:

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

Spiolto® Respimat® /Pulmicort®/TQC3302

Experimental group

Description:

Each drug is administered as a single dose. Pulmicort®: Budesonide Powder for Inhalation (200μg); TQC3302 inhalation spray (50/2.5/2.5μg); TQC3302 inhalation spray (100/2.5/2.5μg); Spiolto® Respimat®: Tiotropium bromide and olodaterol hydrochloride inhalation spray (2.5/2.5μg)

Treatment:

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

TQC3302 inhalation spray (200/5/5μg)-single dose

Experimental group

Description:

TQC3302 inhalation spray is administered as a single dose.

Treatment:

Drug: TQC3302 inhalation spray

TQC3302 inhalation spray (100/5/5μg)

Experimental group

Description:

Single dose during Day 1-Day 7

Treatment:

Drug: TQC3302 inhalation spray