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This project is the stage of dose escalation, is was divided into single and multiple dose clinical study, This is a multi-center, randomized, double-blind, placebo-controlled , study to the safety, tolerability and pharmacokinetic characteristics of TQC3927 powder for inhalation in Chronic Obstructive Pulmonary Disease
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TQC3927 powder for inhalation | Experimental | TQC3927 powder for inhalation is administered as a single administration for 1 day and continuous administration for 6 days. |
|
| TQC3927 powder for inhalation placebo | Active Comparator | TQC3927 powder for inhalation placebo is administered as a single administration for 1 day and continuous administration for 6 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TQC3927 powder for inhalation | Drug | TQC3927 is a targeted inhibitor |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events (AE) | The occurrence of all adverse events (AE) including abnormal laboratory test indicators. | From the use of the investigational drug until the last study visit, up to day 16 |
| Serious adverse events (SAE) | The occurrence of all serious adverse events (SAE) . | From the use of the investigational drug until the last study visit, up to day 16 |
| Forced expiratory volume (FEV1) trough value changed from baseline | After administration of Day1 and Day7, the FEV1 trough value changed from baseline. The changes in FEV1 before administration of Day3 and Day5 compared to baseline. | After administration of Day1 and Day7,before administration of Day3 and Day5 |
| Forced vital capacity (FVC) changes compared to baseline | FVC changes compared to baseline at each lung function visit point. | After administration of Day1 and Day7,before administration of Day3 and Day5 |
| The peak FEV1 value changed from baseline | After administration of Day1 and Day7, the peak FEV1 value changed from baseline. | After administration of Day1 and Day7,before administration of Day3 and Day5 |
| The area under the FEV1 curve of the average change from baseline | The area under the FEV1 curve of the average change from baseline after administration of D1 and D7 ranges from 0-6h (AUC0-6h), 0-12h (AUC0-12h), 12-24h (AUC12-24h), 0-24h (AUC0-24h), and FVC AUC (0-24h). | After administration of Day1 and Day7,before administration of Day3 and Day5 |
| Measure | Description | Time Frame |
|---|---|---|
| Peak concentration (Cmax) | The Cmax is the maximum observed plasma concentration of study drug. | Day1: pre-dose, at 15,30,45 minutes,1,2,4,6,8,12,24 hours after-dose, Day5: pre-dose, Day6: pre-dose, Day7: pre-dose, at 15,30,45 minutes,1,2,4,6,8,12,24,48,72 hours after-dose |
| Area Under the Concentration-Time Curve From 0 to Last Observation (AUC [0-t]) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China Japan Friendship Hospital | Beijing | Beijing Municipality | 100000 | China | ||
| Aerospace Center Hospital |
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| TQC3927 powder for inhalation placebo |
| Drug |
A placebo without drug substance. |
|
| The change in chronic obstructive pulmonary disease (CAT) score from baseline | The change in chronic obstructive pulmonary disease (CAT) score from baseline on the day after Day7 administration. | After administration of Day1 and Day7,before administration of Day3 and Day5 |
To characterize the pharmacokinetics of TQC3927 by assessment of area under the plasma concentration time curve from the first dose to a certain time point. |
| Day1: pre-dose, at 15,30,45 minutes,1,2,4,6,8,12,24 hours after-dose, Day5: pre-dose, Day6: pre-dose, Day7: pre-dose, at 15,30,45 minutes,1,2,4,6,8,12,24,48,72 hours after-dose |
| Area Under the Concentration-Time Curve From Zero to Infinity (AUC [0-infinity]) | To characterize the pharmacokinetics of TQC3927 by assessment of area under the plasma concentration time curve from 0 extrapolated to infinity. | Day1: pre-dose, at 15,30,45 minutes,1,2,4,6,8,12,24 hours after-dose, Day5: pre-dose, Day6: pre-dose, Day7: pre-dose, at 15,30,45 minutes,1,2,4,6,8,12,24,48,72 hours after-dose |
| Time to reach maximum (peak) plasma concentration following drug administration (Tmax) | To characterize the pharmacokinetics of TQC3927 by assessment of time to reach maximum plasma concentration after single and multiple dosing. | Day1: pre-dose, at 15,30,45 minutes,1,2,4,6,8,12,24 hours after-dose, Day5: pre-dose, Day6: pre-dose, Day7: pre-dose, at 15,30,45 minutes,1,2,4,6,8,12,24,48,72 hours after-dose |
| Half-life (t1/2) | Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma. | Day1: pre-dose, at 15,30,45 minutes,1,2,4,6,8,12,24 hours after-dose, Day5: pre-dose, Day6: pre-dose, Day7: pre-dose, at 15,30,45 minutes,1,2,4,6,8,12,24,48,72 hours after-dose |
| Apparent volume of distribution(Vd/F) | Apparent volume of distribution of the TQC3927 in plasma | Day1: pre-dose, at 15,30,45 minutes,1,2,4,6,8,12,24 hours after-dose, Day5: pre-dose, Day6: pre-dose, Day7: pre-dose, at 15,30,45 minutes,1,2,4,6,8,12,24,48,72 hours after-dose |
| Apparent clearance (CLz/F) | Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the body. | Day1: pre-dose, at 15,30,45 minutes,1,2,4,6,8,12,24 hours after-dose, Day5: pre-dose, Day6: pre-dose, Day7: pre-dose, at 15,30,45 minutes,1,2,4,6,8,12,24,48,72 hours after-dose |
| End elimination rate (λz) | Derived from semi logarithmic linear regression of eliminating phase concentration points. | Day1: pre-dose, at 15,30,45 minutes,1,2,4,6,8,12,24 hours after-dose, Day5: pre-dose, Day6: pre-dose, Day7: pre-dose, at 15,30,45 minutes,1,2,4,6,8,12,24,48,72 hours after-dose |
| Residual area percentage (AUC_%Extrap) | Residual area percentage of the TQC3927 in plasma. | Day1: pre-dose, at 15,30,45 minutes,1,2,4,6,8,12,24 hours after-dose, Day5: pre-dose, Day6: pre-dose, Day7: pre-dose, at 15,30,45 minutes,1,2,4,6,8,12,24,48,72 hours after-dose |
| Average dwell time(MRT0-t) | The average residence time from 0:00 to the last measurable concentration time point. | Day1: pre-dose, at 15,30,45 minutes,1,2,4,6,8,12,24 hours after-dose, Day5: pre-dose, Day6: pre-dose, Day7: pre-dose, at 15,30,45 minutes,1,2,4,6,8,12,24,48,72 hours after-dose |
| Average dwell time(MRT0-∞) | Average residence time from 0:00 to infinity. | Day1: pre-dose, at 15,30,45 minutes,1,2,4,6,8,12,24 hours after-dose, Day5: pre-dose, Day6: pre-dose, Day7: pre-dose, at 15,30,45 minutes,1,2,4,6,8,12,24,48,72 hours after-dose |
| Beijing |
| Beijing Municipality |
| 100049 |
| China |
| The First Affiliated Hospital of Nanchang University | Nanchang | Jiangxi | 330038 | China |
| Heze Municipal Hospital | Heze | Shandong | 274031 | China |
| Zibo Municipal Hospital | Zibo | Shandong | 255400 | China |
| The Third People Hospital of Chengdu | Chengdu | Sichuan | 610031 | China |
| The Second Affiliated Hospital of Wenzhou Medical University | Wenzhou | Zhejiang | 325027 | China |
| 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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| 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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