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This is a randomized, double-blind, placebo-controlled, dose escalation, multicenter study design. The purpose is to evaluate the safety, tolerability, pharmacokinetics, and pharmacokinetic characteristics of TQC3721 inhalation powder in Chronic Obstructive Pulmonary Disease(COPD) patients with single/multiple dose escalation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TQC3721 inhalation powder | Experimental | TQC3721 inhalation powder is administered as a single dose or continuously for 7 days. |
|
| Placebo for TQC3721 inhalation powder | Placebo Comparator | Placebo for TQC3721 inhalation powder inhalation is administered as a single dose or continuously for 7 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TQC3721 inhalation powder | Drug | TQC3721 is a target inhibitor. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events (AE) | Incidence of adverse events (AE) | 19 days |
| Serious Adverse Events (SAE) | Incidence of Serious Adverse Events (SAE) | 19 days |
| Treatment-emergent adverse events (TEAEs) | Incidence of treatment-emergent adverse events (TEAEs) | 19 days |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma drug peak concentration | Plasma drug peak concentration after administration. | 9 days |
| COPD Assessment Tes (CAT) scores | CAT score after administration. The score range is 0 to 40 points (0 to 10 is minor influence; 11 to 20 are moderate; 21 to 30 are classified as severe impact; 31 to 40 is very severe). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fengming Luo, Doctor | Contact | 18980601355 | fengmingluo@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital of Sichuan University | Recruiting | Chengdu | Sichuan | 610000 | China |
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| Placebo for TQC3721 inhalation powder |
| Drug |
Placebo without drug substance. |
|
| From day 1 to day 11 or end of treatment, whichever came first |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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