Effects of Inhaled Epinephrine on Systemic Allergic Reactions During Allergy Testing, Immunotherapy or Oral Challenges

This is a Phase 1b, multi-center, open label exploratory study evaluating the effects of inhaled epinephrine in patients who are undergoing planned allergy testing, SCIT, oral challenges (with food and/or drug), or OIT and are not eligible for the GHL-101 study. This study will enroll and dose up to 100 patients.

The maximum duration of subject participation is approximately 1 week.

• Inhaled Epinephrine (Drug): 0.125 mg per inhalation. The maximum proposed dose to be administered is 1.0 mg (consisting of 8 inhalations of 0.125 mg over 6 minutes).

Primary outcomes

• Time to resolution of systemic symptoms [From first dose administration to 60 minutes following first dose administration]: Defined as a reduction in systemic allergic reaction (SAR) Grade to ≤ 1. Grade 0 is considered the absence of any symptoms and per World Allergy Organisation's Grading System for Systemic Allergic Reactions, Grade 1 is least severe and Grade 5 is most severe.
• Time to complete resolution of systemic symptoms [From first dose administration to 60 minutes following first dose administration]: Defined as a reduction in systemic allergic reaction (SAR) Grade to 0. Grade 0 is considered the absence of any symptoms and per World Allergy Organisation's Grading System for Systemic Allergic Reactions, Grade 1 is least severe and Grade 5 is most severe.

Sex: All, ages: 12 Years to any

Inclusion Criteria:

1. Males or females, aged ≥ 12 years with known or suspected allergen sensitivity who can also have a clinical history of immunoglobulin E (IgE)-mediated allergy, including a documented sensitivity to allergens (i.e., positive skin prick test, or positive in vitro serum IgE).
2. Have undergone either a) allergy testing for suspected sensitivity/allergy, b) future oral challenge (food and/or drug) or future OIT to treat existing allergies or c) SCIT AND experienced a SAR Grade 2 or higher, following allergy testing, SCIT, or oral challenges (food and/or drug) for future OIT, and deemed eligible for enrollment by the Principal Investigator.
3. For females of child-bearing potential, not pregnant or lactating, willing to use an acceptable contraception* method between Screening and End-of-Study Visits.

Exclusion Criteria:

1. Known reaction or sensitivity to epinephrine or any of the ingredients of inhaled epinephrine.
2. Known history or presence of clinically disease/condition that could confound the results of the study or place the subject at undue or additional risk per the judgment of the Investigator.
3. Abnormal vital signs at screening (i.e., systolic blood pressure: < 90 or >140 mmHg, diastolic blood pressure: < 40 or > 90 mmHg or, heart rate: < 45 or > 100 bpm), respiration rate < 8 or > 20 resp./min.
4. Females who are pregnant, plan to become pregnant or lactating.
5. Participation in another clinical study involving an investigational drug within 30 days prior to screening, an investigational biologic within 60 days prior to screening, or current/planned participation in another interventional study during this study.
6. Previous treatment in this study.
7. Any other reason that, in the opinion of the Investigator, is likely to unfavorably alter subject risk-benefit, confound results, or make it difficult for the subject to fully comply with study requirements.

• George H. Luciuk, MD, Principal investigator, Kokua Pharma Inc.