Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
A006 · 1 trial · 3 indications
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...
A006 is an investigational small molecule being developed for the treatment of asthma. It is also being studied for related respiratory conditions, including bronchospasm and chronic obstructive pulmonary disease (COPD). The drug is currently in Phase 2 clinical development and has not been approved by the FDA.
A006 is being developed by Amphastar Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol AMPH. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with respiratory conditions.
A006 is in Phase 2 clinical development. It is an investigational drug, meaning it has not yet received FDA approval. One Phase 2 clinical trial has been completed, which enrolled 27 participants to study the drug's pharmacokinetics, pharmacodynamics, and safety.
A006 has one completed clinical trial registered under NCT01189396. This was a Phase 2, randomized, double-blind, placebo-controlled study titled "Escalating and Cumulative-Dose Study of Pharmacokinetics (PK), Pharmacodynamics (PD) and Safety of A006." The trial enrolled 27 adults in the United States with asthma, bronchospasm, or COPD.
No alternative names for A006 have been disclosed. The drug is identified solely by its development code A006 in clinical trial registrations and company communications. It is a distinct investigational compound being developed by Amphastar Pharmaceuticals.