Pharmacokinetics (PK) Study of Epinephrine Inhalation Aerosol in Healthy Volunteers

This study is a randomized, evaluator-blind, single dose, three-arm, crossover, PK study, to
be conducted in ~18 healthy, male and female, adult volunteers. PK will be studied at two
dose strengths (Arm T1 and Arm T2). A currently marketed, non-labeled, Epinephrine CFC-MDI
will be used as a Reference Control (Arm C).

- At the Screening Visit and the beginning of each Study Visit, each subject will be
trained on the correct self-administration of MDI. The following three randomized
treatments will be self-administered, at three Study Visits:

- Treatment T1: Ten (10) inhalations of the low dose E004(125 mcg/inhalation),
totaling 1.25 mg of epinephrine;

- Treatment T2: Ten (10) inhalations of the high dose E004 (160 mcg/inhalation),
totaling 1.60 mg of epinephrine;

- Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation,
totaling 2.2 mg of epinephrine base equivalent).

- PK blood samples will be taken from a vein at scheduled time points.

- Safety parameters and adverse drug events, if any, will be monitored and documented at
each study visit. An End-of-Study (EOS) safety evaluation will be conducted.

Inclusion Criteria:

- Generally healthy, male and female adults, 18-30 yrs of age at Screening;

- Having no clinically significant respiratory, cardiovascular and other systemic or
organic illnesses, per investigator discretion;

- Women of child-bearing potential must be non-pregnant, non-lactating, and practicing a
clinically acceptable form of birth control;

- Having properly consented and satisfied all other inclusion/exclusion criteria as
required for this protocol.

- Other criteria apply.

Exclusion Criteria:

- A recent or significant smoking history;

- Use of prohibited drugs or failure to observe the drug washout restrictions;

- Having been on other investigational drug/device studies in the last 30 days prior to
Screening.

- Other criteria apply