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This is a dose escalation trial. The dosing regimen involves a single-dose study. This is a single-center, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability and pharmacokinetic characteristics of TQC3927 powder for inhalation in healthy adults subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TQC3927 powder for inhalation | Experimental | TQC3927 powder for inhalation is administered as a single dose |
|
| TQC3927 powder for inhalation placebo | Placebo Comparator | TQC3927 powder for inhalation placebo is administered as a single dose |
|
| 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). | From the use of the investigational drug until the last study visit, up to Day 9. |
| 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 9. |
| Abnormal security check | The frequency, incidence, and severity of laboratory tests, vital signs, physical examinations, electrocardiogram examinations, etc. | From the use of the investigational drug until the last study visit, up to Day 9. |
| Pharmacokinetics:Peak concentration (Cmax) | The Cmax is the maximum observed plasma concentration of study drug. | Single Day1: pre-dose, at 5,15,30,45 minutes,1,2,4,6,8,12,24,36,48,72 hours after-dose. |
| Area Under the Concentration-Time Curve From 0 to Last Observation (AUC [0-t]) | 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. | Single Day1: pre-dose, at 5,15,30,45 minutes,1,2,4,6,8,12,24,36,48,72 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. | Single Day1: pre-dose, at 5,15,30,45 minutes,1,2,4,6,8,12,24,36,48,72 hours after-dose. |
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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 |
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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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| TQC3927 powder for inhalation placebo |
| Drug |
TQC3927 powder for inhalation placebo contains no active substance. |
|
| 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 | Single Day1: pre-dose, at 5,15,30,45 minutes,1,2,4,6,8,12,24,36,48,72 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. | Single Day1: pre-dose, at 5,15,30,45 minutes,1,2,4,6,8,12,24,36,48,72 hours after-dose. |
| Apparent volume of distribution(Vd/F) | Apparent volume of distribution of the TQC3927 in plasma. | Single Day1: pre-dose, at 5,15,30,45 minutes,1,2,4,6,8,12,24,36,48,72 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. | Single Day1: pre-dose, at 5,15,30,45 minutes,1,2,4,6,8,12,24,36,48,72 hours after-dose. |
| End elimination rate (λz) | Derived from semi logarithmic linear regression of eliminating phase concentration points. | Single Day1: pre-dose, at 5,15,30,45 minutes,1,2,4,6,8,12,24,36,48,72 hours after-dose. |
| Residual area percentage of the TQC3927 (AUC_%Extrap) | Residual area percentage of the TQC3927 in plasma | Single Day1: pre-dose, at 5,15,30,45 minutes,1,2,4,6,8,12,24,36,48,72 hours after-dose |
| Mean residence time from zero to last measurable concentration (MRT0-t) | The average residence time from 0:00 to the last measurable concentration time point. | Single Day1: pre-dose, at 5,15,30,45 minutes,1,2,4,6,8,12,24,36,48,72 hours after-dose. |
| Mean residence time from zero to infinity (MRT0-∞) | Average residence time from 0:00 to infinity. | Single Day1: pre-dose, at 5,15,30,45 minutes,1,2,4,6,8,12,24,36,48,72 hours after-dose. |
| Accumulated excretion of drugs in urine and feces (Aecum) | Accumulated excretion of drugs in urine and feces from zero to time t. | Single Day1: pre-dose, at 5,15,30,45 minutes,1,2,4,6,8,12,24,36,48,72 hours after-dose. |
| Accumulated excretion of drugs in urine (Aeu,cum) | Accumulated excretion of drugs in urine from zero to time t. | Single Day1: pre-dose, at 5,15,30,45 minutes,1,2,4,6,8,12,24,36,48,72 hours after-dose. |
| Accumulated excretion of drugs in feces(Aef,cum) | Accumulated excretion of drugs in feces from zero to time t. | Single Day1: pre-dose, at 5,15,30,45 minutes,1,2,4,6,8,12,24,36,48,72 hours after-dose. |
| Renal clearance (CLr) | The ability of the kidneys to clear certain substances from plasma within 1 minute. | Single Day1: pre-dose, at 5,15,30,45 minutes,1,2,4,6,8,12,24,36,48,72 hours after-dose. |
| Total drug excretion ratio in urine and feces (Fe%) | The total excretion ratio of drugs in urine and feces from zero to time t. | Single Day1: pre-dose, at 5,15,30,45 minutes,1,2,4,6,8,12,24,36,48,72 hours after-dose. |
| Drug excretion ratio in urine (Fe%u) | The proportion of drug excretion in urine from zero to time t. | Single Day1: pre-dose, at 5,15,30,45 minutes,1,2,4,6,8,12,24,36,48,72 hours after-dose. |
| Drug excretion ratio in feces (Fe%f) | The proportion of drug excretion in feces from zero to time t. | Single Day1: pre-dose, at 5,15,30,45 minutes,1,2,4,6,8,12,24,36,48,72 hours after-dose. |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |