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Groups 1, 3, 4, 5 and 6 of this research team adopted a single-center, open-label design. Group 2 used a three-sequence, three-period crossover design, where participants in this dose group were randomly assigned to the three sequences in a 1:1:1 ratio to undergo three-period crossover administration. Healthy adult subjects were selected to use TQC3302 inhalation spray to evaluate the safety, tolerability, and pharmacokinetic characteristics of single and multiple inhalations of TQC3302 inhalation spray in healthy participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TQC3302 inhalation spray (50/2.5/2.5μg) | Experimental | Administered as a single dose |
|
| TQC3302/Spiolto® Respimat® /Pulmicort® | Experimental | Each drug is administered as a single dose. TQC3302 inhalation spray (200/2.5/2.5μg); Spiolto® Respimat® : Tiotropium bromide and olodaterol hydrochloride inhalation spray (2.5/2.5μg); Pulmicort® : Budesonide Powder for Inhalation (200μg) |
|
| Pulmicort®/Spiolto® Respimat® | Experimental | Each drug is administered as a single dose. Spiolto® Respimat®: Tiotropium bromide and olodaterol hydrochloride inhalation spray (2.5/2.5μg) ; Pulmicort®: Budesonide Powder for Inhalation (200μg) TQC3302 inhalation spray (200/2.5/2.5μg) |
|
| Spiolto® Respimat® /Pulmicort®/TQC3302 | Experimental | Each drug is administered as a single dose. Pulmicort®: Budesonide Powder for Inhalation (200μg); TQC3302 inhalation spray (200/2.5/2.5μg); Spiolto® Respimat®: Tiotropium bromide and olodaterol hydrochloride inhalation spray (2.5/2.5μg) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TQC3302 inhalation spray | Drug | TQC3302 inhalation spray is a targeted inhibitor |
|
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Emergent Adverse Event | The incidence and severity of adverse events after treatment From the use of the investigational drug until the last study visit. | From the use of the investigational drug until the last study visit, up to Day 14 |
| The subject with 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 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax after dose | The Cmax is the maximum observed plasma concentration of study drug | Single dose：pre-dose, at 2,5,8,12,25,45 minutes,1,2,4,8,12,24, 48,72,120 hours after-dose (When using Budesonide Powder for Inhalation, there is no need to monitor at 48, 72, and 120 hours after the end of administration) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jintong Li, Doctor | Contact | 15300059186 | gcpljt@189.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China Japan Friendship Hospital Beijing | Recruiting | Beijing | Beijing Municipality | 100000 | China |
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| TQC3302 inhalation spray (200/5/5μg)-single dose | Experimental | TQC3302 inhalation spray is administered as a single dose. |
|
| TQC3302 inhalation spray (400/5/5μg) | Experimental | TQC3302 inhalation spray is administered as a single dose |
|
| TQC3302 inhalation spray (200/5/5μg) | Experimental | Single dose during Day 1-Day 7 |
|
| TQC3302 inhalation spray (400/5/5μg)-single dose | Experimental | single dose during Day 1-Day 7 |
|
| TQC3302 inhalation spray (400/5/5μg) -two dose | Experimental | Two dose during Day 1-Day 7 |
|
| TQC3302 inhalation spray+Tiotropium bromide and olodaterol hydrochloride inhalation spray +Budesonide Powder for Inhalation | Drug | TQC3302 inhalation spray is a targeted inhibitor, Tiotropium bromide and olodaterol hydrochloride inhalation spray is a targeted inhibitor, Budesonide Powder for Inhalation is a Inhaled Corticosteroids. |
|
| Tiotropium bromide and olodaterol hydrochloride inhalation spray +Budesonide Powder for Inhalation+ TQC3302 inhalation spray | Drug | TQC3302 inhalation spray is a targeted inhibitor, Tiotropium bromide and olodaterol hydrochloride inhalation spray is a targeted inhibitor, Budesonide Powder for Inhalation is a Inhaled Corticosteroids. |
|
| Budesonide Powder for Inhalation+ TQC3302 inhalation spray+ Tiotropium bromide and olodaterol hydrochloride inhalation spray | Drug | TQC3302 inhalation spray is a targeted inhibitor, Tiotropium bromide and olodaterol hydrochloride inhalation spray is a targeted inhibitor, Budesonide Powder for Inhalation is a Inhaled Corticosteroids. |
|
| TQC3302 inhalation spray | Drug | TQC3302 inhalation spray is a targeted inhibitor |
|
| Area Under the Concentration-Time Curve From 0 to Last Observation (AUC [0-t]) |
To characterize the pharmacokinetics of TQC3302 by assessment of area under the plasma concentration time curve from the first dose to a certain time point |
| Single dose：pre-dose, at 2,5,8,12,25,45 minutes,1,2,4,8,12,24, 48,72,120 hours after-dose (When using Budesonide Powder for Inhalation, there is no need to monitor at 48, 72, and 120 hours after the end of administration) |
| Area Under the Concentration-Time Curve From Zero to Infinity (AUC [0-infinity]) | To characterize the pharmacokinetics of TQC3302 by assessment of area under the plasma concentration time curve from 0 extrapolated to infinity. | Single dose：pre-dose, at 2,5,8,12,25,45 minutes,1,2,4,8,12,24, 48,72,120 hours after-dose (When using Budesonide Powder for Inhalation, there is no need to monitor at 48, 72, and 120 hours after the end of administration) |
| Time to reach maximum (peak) plasma concentration following drug administration (Tmax) | To characterize the pharmacokinetics of TQC3302 by assessment of time to reach maximum plasma concentration after single dosing. | Single dose：pre-dose, at 2,5,8,12,25,45 minutes,1,2,4,8,12,24, 48,72,120 hours after-dose (When using Budesonide Powder for Inhalation, there is no need to monitor at 48, 72, and 120 hours after the end of administration) |
| 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 dose：pre-dose, at 2,5,8,12,25,45 minutes,1,2,4,8,12,24, 48,72,120 hours after-dose (When using Budesonide Powder for Inhalation, there is no need to monitor at 48, 72, and 120 hours after the end of administration) |
| Apparent volume of distribution (Vd/F) | Apparent volume of distribution of the TQC3302 in plasma. | Single dose：pre-dose, at 2,5,8,12,25,45 minutes,1,2,4,8,12,24, 48,72,120 hours after-dose (When using Budesonide Powder for Inhalation, there is no need to monitor at 48, 72, and 120 hours after the end of administration) |
| Apparent clearance (CL/F) | Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the body. | Single dose：pre-dose, at 2,5,8,12,25,45 minutes,1,2,4,8,12,24, 48,72,120 hours after-dose (When using Budesonide Powder for Inhalation, there is no need to monitor at 48, 72, and 120 hours after the end of administration) |
| Peak concentration (Cmax) after the first administration | The Cmax is the maximum observed plasma concentration of study drug. | Multiple dosing: at 2, 5, 8, 12, 25, 45 minutes, 1, 2, 4, 8, 12 hours after the first administration |
| Time to reach maximum (peak) plasma concentration after the first administration (Tmax) | To characterize the pharmacokinetics of TQC3302 by assessment of time to reach maximum plasma concentration after the first administration. | Multiple dosing: at 2, 5, 8, 12, 25, 45 minutes, 1, 2, 4, 8, 12 hours after the first administration |
| Half-life after the first administration | Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma. | Multiple dosing: at 2, 5, 8, 12, 25, 45 minutes, 1, 2, 4, 8, 12 hours after the first administration |
| Area Under the Concentration-Time Curve From 0 to Last Observation after the first administration | To characterize the pharmacokinetics of TQC3302 by assessment of area under the plasma concentration time curve from the first dose to a certain time point. | Multiple dosing: at 2, 5, 8, 12, 25, 45 minutes, 1, 2, 4, 8, 12 hours after the first administration |
| Area Under the Concentration-Time Curve From Zero to Infinity after the first administration | To characterize the pharmacokinetics of TQC3302 by assessment of area under the plasma concentration time curve from 0 extrapolated to infinity | Multiple dosing: at 2, 5, 8, 12, 25, 45 minutes, 1, 2, 4, 8, 12 hours after the first administration |
| Peak concentration (Cmax) | The Cmax is the maximum observed plasma concentration of study drug | Multiple dosing: at 2, 5, 8, 12, 25, 45 minutes, 1, 2, 4, 8, 12, 24 hours after the first dose, before Day 5, 6, 7, at 2, 5, 8,1 2, 25, 45 minutes, 1, 2 , 4, 8, 12, 24, 48, 72, 120 hours after Day 7 dose |
| Time to reach maximum (peak) plasma concentration following drug administration | To characterize the pharmacokinetics of TQC3302 by assessment of time to reach maximum plasma concentration after multiple dosing | Multiple dosing: at 2, 5, 8, 12, 25, 45 minutes, 1, 2, 4, 8, 12, 24 hours after the first dose, before Day 5, 6, 7, at 2, 5, 8,1 2, 25, 45 minutes, 1, 2 , 4, 8, 12, 24, 48, 72, 120 hours after Day 7 dose |
| Area Under the Concentration-Time Curve From 0 to Last Observation (AUC [0-t]) | To characterize the pharmacokinetics of TQC3302 by assessment of area under the plasma concentration time curve from the first dose to a certain time point | Multiple dosing: at 2, 5, 8, 12, 25, 45 minutes, 1, 2, 4, 8, 12, 24 hours after the first dose, before Day 5, 6, 7, at 2, 5, 8,1 2, 25, 45 minutes, 1, 2 , 4, 8, 12, 24, 48, 72, 120 hours after Day 7 dose |
| Area Under the Concentration-Time Curve From Zero to Infinity (AUC [0-infinity]) | To characterize the pharmacokinetics of TQC3302 by assessment of area under the plasma concentration time curve from 0 extrapolated to infinity. | Multiple dosing: at 2, 5, 8, 12, 25, 45 minutes, 1, 2, 4, 8, 12, 24 hours after the first dose, before Day 5, 6, 7, at 2, 5, 8,1 2, 25, 45 minutes, 1, 2 , 4, 8, 12, 24, 48, 72, 120 hours after Day 7 dose |
| Area Under the Concentration-Time Profile From Time Zero to the Dosing Interval Tau | Area Under the Concentration-Time Profile From Time Zero to the Dosing Interval Tau (AUCtau) of TQC3302 from the first dose to a certain time point. | Multiple dosing: at 2, 5, 8, 12, 25, 45 minutes, 1, 2, 4, 8, 12, 24 hours after the first dose, before Day 5, 6, 7, at 2, 5, 8,1 2, 25, 45 minutes, 1, 2 , 4, 8, 12, 24, 48, 72, 120 hours after Day 7 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 | Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma. | Multiple dosing: at 2, 5, 8, 12, 25, 45 minutes, 1, 2, 4, 8, 12, 24 hours after the first dose, before Day 5, 6, 7, at 2, 5, 8,1 2, 25, 45 minutes, 1, 2 , 4, 8, 12, 24, 48, 72, 120 hours after Day 7 dose |
| Accumulation ratio based on peak concentration (Rac (Cmax)) | Accumulation ratio based on peak concentration (Rac (Cmax)) | Multiple dosing: at 2, 5, 8, 12, 25, 45 minutes, 1, 2, 4, 8, 12, 24 hours after the first dose, before Day 5, 6, 7, at 2, 5, 8,1 2, 25, 45 minutes, 1, 2 , 4, 8, 12, 24, 48, 72, 120 hours after Day 7 dose |
| Accumulation ratio based on AUC | Accumulation ratio based on AUC | Multiple dosing: at 2, 5, 8, 12, 25, 45 minutes, 1, 2, 4, 8, 12, 24 hours after the first dose, before Day 5, 6, 7, at 2, 5, 8,1 2, 25, 45 minutes, 1, 2 , 4, 8, 12, 24, 48, 72, 120 hours after Day 7 dose |
| 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 |
| D000069447 | Tiotropium Bromide |
| ID | Term |
|---|---|
| D015656 | Respiratory Mechanics |
| D012119 | Respiration |
| D012143 | Respiratory Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
| D012602 | Scopolamine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
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