Epinephrine Inhalation Aerosol USP, CLINICAL STUDY-B3 FOR ASSESSMENT OF PHARMACOKINETICS

The current study is designed to complement and expand the previous PK studies,
API-E004-CL-B and API-E004-CL-B2, with emphasis on lower E004 dose strengths (at 90 and 100
mcg per inhalation), for a more thorough evaluation of the E004 PK profiles. Safety of E004
will also be evaluated, under augmented dose conditions.

Inclusion Criteria:

- Generally healthy at screening;

- Body weight ≥ 50 kg for men and ≥ 45 kg for women;

- Sitting blood pressure ≤ 135/90 mmHg;

- Demonstrating negative hIV, HBsAG and DCV-Ab screen tests;

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

- Properly consented

- Other criteria apply

Exclusion Criteria:

- A smoking history of ≥10 pack-years, or having smoked within 6 months prior to
Screening;

- Upper respiratory tract infections within 2 wk, or lower respiratory tract infection
within 4 wk, prior to Screening;

- Any current or recent respiratory conditions that might significantly affect
pharmacodynamic response to the study drugs;

- Known intolerance or hypersensitivity to the study MDI ingredients;

- Having been on other investigational drug/device studies, or donated blood, in the
last 30 days prior to Screening;

- Other criteria apply