To evaluate the safety, tolerability and pharmacokinetic characteristics of TQC3721 suspension for inhalation in single/multiple administration(s) in healthy subjects; to evaluate the safety,tolerability and efficacy TQC3721 suspension for inhalation in multiple administrations in patients with Chronic Obstructive Pulmonary Disease(COPD)and asthma.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
114
Participants will receive 0.2 mg/1.0 mg/3.0 mg/6.0 mg/12.0 mg/24.0 mg single dose of TQC3721 suspension for inhalation.
Participants will receive 0mg single dose of TQC3721 suspension placebo for inhalation .
West China Hospital of Sichuan University
Chengdu, Sichuan, China
RECRUITINGNumber of adverse events
The Number of adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Time frame: From the enrollment of the subjects to 72 hours after the last administration
Incidence of adverse events
The Incidence of adverse events as assessed by CTCAE v5.0
Time frame: From the enrollment of the subjects to 72 hours after the last administration
Number of adverse events related to the study drug
The number of adverse events associated with the study drug assessed by CTCAE V5.0
Time frame: From the enrollment of the subjects to 72 hours after the last administration
Incidence of adverse events associated with the study drug
Incidence of adverse events associated with the study drug as assessed by CTCAE V5.0
Time frame: From the enrollment of the subjects to 72 hours after the last administration
Area Under The Curve(AUC)
Area under the curve
Time frame: Within 60 minutes before each administration, to 72 hours after administration
Plasma drug peak concentration(Cmax )
Plasma drug peak concentration
Time frame: Within 60 minutes before each administration, to 72 hours after administration
Time to peak(Tmax)
Time to maximum concentration following drug administration
Time frame: Within 60 minutes before each administration, to 72 hours after administration
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Elimination half-life time(t1/2)
Apparent terminal elimination half-life following drug administration
Time frame: Within 60 minutes before each administration, to 72 hours after administration
Apparent volume of distribution(Vd)
Apparent volume of distribution
Time frame: Within 60 minutes before each administration, to 72 hours after administration
Clearance(CL)
Clearance
Time frame: Within 60 minutes before each administration, to 72 hours after administration
Forced Expiratory Volume in the first second (FEV1) for patients with Chronic Obstructive Pulmonary Disease(COPD) or asthma
Mean Change From Baseline in Peak FEV1 (Over 3 Hours)
Time frame: From before administration to 3 hours after administration
Mean Change From Baseline FEV1 to Morning Trough FEV1
Mean Change From Baseline FEV1 to Morning Trough FEV1
Time frame: From the enrollment of the subjects to to 72 hours after administration
Mean Change From Baseline FEV1 to Average FEV1
Mean Change From Baseline FEV1 to Average FEV1
Time frame: From the enrollment of the subjects to to 72 hours after administration
COPD Assessment Test (CAT) for patients with COPD
Mean Change From Baseline in COPD Assessment Test (CAT) Scoring at Week 4.The score range is 0 to 40 (0 to 10 is minor influence;11 to 20 is moderate; 21 to30 is severe;31 to 40 is very severe), and more than 10 indicates more symptoms.
Time frame: From enrollment to 4 weeks after administration
Modified medical research council(mMRC) for patients with COPD or asthma
Mean Change From Baseline in mMRC Scoring at Week 4.The severity is measured on a five-point scale from 0 to 4, with a higher score indicating more severe respiratory distress.
Time frame: From enrollment to 4 weeks after administration