Staccato Loxapine Pulmonary Safety in Healthy Volunteers

Pulmonary Safety of Repeat Doses of Staccato® Loxapine for Inhalation in Healthy Volunteers

The objective of this trial is to assess the pulmonary safety of 2 inhaled doses of Staccato Loxapine within a day.

The planned study is a multiple dose, double-blind, placebo-controlled, randomized, 2-sequence, 2-period crossover study investigating pulmonary safety in healthy volunteers.

Inclusion Criteria:

• nonsmoker subjects in good general health with normal spirometry at screening AND baseline

Exclusion Criteria:

• history of asthma, COPD, or any other acute or chronic pulmonary disease or bronchodilator use