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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TQC3721 suspension for inhalation | Experimental | 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 on Day 1. |
|
| TQC3721 suspension placebo for inhalation | Placebo Comparator | Participants will receive 0mg single dose of TQC3721 suspension placebo for inhalation on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TQC3721 suspension for inhalation | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse events | The Number of adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 | 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 | 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 | 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 | From the enrollment of the subjects to 72 hours after the last administration |
| Area Under The Curve(AUC) | Area under the curve | Within 60 minutes before each administration, to 72 hours after administration |
| Plasma drug peak concentration(Cmax ) | Plasma drug peak concentration | Within 60 minutes before each administration, to 72 hours after administration |
| Time to peak(Tmax) | Time to maximum concentration following drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| Elimination half-life time(t1/2) | Apparent terminal elimination half-life following drug administration | Within 60 minutes before each administration, to 72 hours after administration |
| Apparent volume of distribution(Vd) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Weimin Li, Post Doctor | Contact | 028-85423837 | llllllv2@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital of Sichuan University | Recruiting | Chengdu | Sichuan | 610044 | China |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D001239 | Inhalation |
| ID | Term |
|---|---|
| D015656 | Respiratory Mechanics |
| D012119 | Respiration |
| D012143 | Respiratory Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
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| TQC3721 suspension placebo for inhalation | Drug | Participants will receive 0mg single dose of TQC3721 suspension placebo for inhalation . |
|
| Within 60 minutes before each administration, to 72 hours after administration |
Apparent volume of distribution
| Within 60 minutes before each administration, to 72 hours after administration |
| Clearance(CL) | Clearance | 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) | 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 | 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 | 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. | 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. | From enrollment to 4 weeks after administration |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |