Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02271334 | Evaluation of Pharmacokinetics and Safety of A006 in Healthy Volunteers | PHASE2 | COMPLETED | 22 | — | — | Aug 1, 2014 | Mar 1, 2015 | Apr 19, 2017 | 1 | United States |
| NCT02210806 | Albuterol DPI (A006) Clinical Study-B3:Efficacy, Dose-ranging and Safety Evaluation | PHASE2 | COMPLETED | 22 | — | — | Jul 1, 2014 | Oct 1, 2014 | Apr 19, 2017 | 4 | United States |
Subject PK blood samples will be taken prior to dosing and at multiple time points, up to 8 hours after dosing during each treatment period. PK samples will be analyzed using a validated test method. Area under the curve of the drug concentration versus time curve (AUC\[0-t\]) for each treatment period will be calculated using the trapezoidal rule.
Subject PK blood samples will be taken prior to dosing and at multiple time points, up to 8 hours after dosing during each treatment period. PK samples will be analyzed using a validated test method. Peak plasma concentration (C\[max\]) will be the highest concentration of Albuterol during each treatment period.
Subject PK blood samples will be taken prior to dosing and at multiple time points, up to 8 hours after dosing during each treatment period. PK samples will be analyzed using a validated test method. Time to reach peak plasma concentration (t\[max\]) will be the time it takes to reach the highest concentration of Albuterol during each treatment period.
Subject PK blood samples will be taken prior to dosing and at multiple time points, up to 8 hours after dosing during each treatment period. PK samples will be analyzed using a validated test method. Plasma Albuterol concentrations at these time points will be reported during each treatment period.
The forced expiratory volume in the 1st second (FEV1) is measured with a clinically accepted model of spirometer. Subjects perform a pre-dose baseline FEV1 prior to dosing and perform subsequent FEV1 tests at 5, 15 and 30 minutes and 1, 1.5, 2, 3, 4, 5, and 6 hours after dosing during each treatment period. Area under the curve (AUC), from baseline to 6 hours post-dose, for the treatment period is calculated using the trapezoidal rule. Statistical analysis is performed using a one-sided t-test.
| Arm | Type | Description |
|---|---|---|
| Treatment T1 | EXPERIMENTAL | One inhalation of 110 mcg A006 DPI. Total 110 mcg |
| Treatment T2 | EXPERIMENTAL | One inhalation of 220 mcg A006 DPI. Total 220 mcg. |
| Treatment R1 | ACTIVE_COMPARATOR | One inhalation of 90 mcg Proventil® MDI. Total 90 mcg. |
| Treatment R2 | ACTIVE_COMPARATOR | Two inhalations of 90 mcg Proventil® MDI. Total 180 mcg |
| Placebo | PLACEBO_COMPARATOR | One inhalation of placebo DPI . Total 0 mcg |
| Name | Type | Description |
|---|---|---|
| A006 DPI | DRUG | Single dose 110 mcg, 1 inhalation |
| Proventil® MDI | DRUG | Single dose 90 mcg, 1 inhalation |
| Placebo DPI | OTHER | Placebo, 1 inhalation |
Inclusion Criteria: * Generally healthy, male and female adults, 18-40 years of age at Screening; * Having no clinically significant respiratory, cardiovascular and other systemic or organic illnesses; * Body weight ≥ 50 kg for men and ≥ 45 kg for women, and BMI within the range of 18.5 - 30.0 kg/m...