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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01189396 | Escalating and Cumulative-Dose Study of Pharmacokinetics (PK), Pharmacodynamics (PD) and Safety of A006 | PHASE2 | COMPLETED | 27 | — | — | Jul 1, 2010 | Jan 1, 2011 | Jul 2, 2017 | 4 | United States |
Area Under the Curve (AUC)0-t of percent change in Forced Expiratory Volume in 1 second (FEV1), which is defined as the area under curve of post-dose FEV1 percentage changes from the Pre-dose Baseline FEV1 (FEV10) versus time. Doses are at 0, 30, 60 and 90 min.
| Arm | Type | Description |
|---|---|---|
| T | EXPERIMENTAL | Four doses of A006 taken in 30 minute intervals. Doses will have an escalating number of inhalations (1, 1, 2, and 4 inhalations). Total cumulative Albuterol dose at 90 minutes is 1440 mcg. |
| R | ACTIVE_COMPARATOR | Four doses of Proventil-HFA taken in 30 minute intervals. Doses will have an escalating number of inhalations (2, 2, 4, and 8 inhalations). Total cumulative Albuterol dose at 90 minutes is 1440 mcg. |
| P | PLACEBO_COMPARATOR | Four doses of Placebo DPI taken in 30 minute intervals. Doses will have an escalating number of inhalations (1, 1, 2, and 4 inhalations). Total cumulative Albuterol dose at 90 minutes is 0 mcg. |
| Name | Type | Description |
|---|---|---|
| A006 | DRUG | Albuterol DPI with 180 mcg Albuterol/inhalation |
| Placebo DPI | DRUG | Placebo DPI with 0 mcg Albuterol/inhalation |
| Proventil-HFA | DRUG | Albuterol MDI with 90 mcg Albuterol/inhalation |
Inclusion Criteria: * Body weight ≥ 50 kg for men and ≥ 45 kg for women, and BMI within the range of 18.5 - 30.0 kg/m2 inclusive; * Sitting blood pressure ≤ 135/90 mmHg; * Demonstrating negative alcohol/drug screen tests; * Demonstrating negative HIV, HBsAg and HCV-Ab screen tests; * With mild-to-m...