Trial of STAHIST in Seasonal Allergic Rhinitis

Phase 3 clinical trial will be conducted in conformance with Good Clinical Practices and is a
multi-center, double-blind, randomized, placebo-controlled, parallel-group study evaluating
the safety and efficacy of STAHIST (IMP) in 300 adult and adolescent subjects 12-60 years of
age, of either sex or any race with a minimum 2-year history of seasonal allergic rhinitis
(SAR) and a baseline minimum total symptom score (TSS) of not less than 8 on the S5 Subject
Diary. Subjects will be treated twice daily with IMP or placebo for a period of two weeks.
Subjects will visit the study site for at least 4 visits: screening, randomization/study
inception, end-of-week one, final visit, and unscheduled visits as appropriate.

Run In (washout period): Subjects will be required to stop using oral nasal decongestants or
first generation antihistamines for 48 hours, second generation antihistamines and Singulair
for seven days, systemic corticosteroids for 30 days, and nasal or ocular corticosteroid
medications for two weeks. Use of these drugs will also not be allowed during the study.

The first dose will be administered at the study site and subjects will be monitored on-site
for one hour following dosing. There will be 24-hour on-call telephone access between
physician/office staff and study subjects.

A Study Flow Chart will be used to facilitate trial management, record completed tasks as
well as document their time of completion (See Study Flow Chart and Source Documents—Appendix
D).

Safety evaluations will include monitoring of subject-reported AEs, measurement of vital
signs, and assessment of safety laboratory data. Qualified independent, non-study
administration individuals will be selected prior to the start of treatment for the purpose
of safety monitoring.

300 subjects will be randomized. Assuming a screen failure test rate of approximately 33%,
approximately 450 subjects will be screened.

At the conclusion of the study, the CSR will be prepared by the Sponsor, reviewed and
approved by the Principal/Coordinator Investigator before submission.

Inclusion Criteria:

1. Male and females of any ethnic group between 12 and 60 years of age.

2. History of moderate to severe Seasonal Allergic Rhinitis (SAR) for at least two years.

3. Subjects' symptoms resulting from the irritation of sinus, nasal and upper respiratory
tract tissues will include the five symptoms ("S5") that are the focus of this study:
nasal congestion, rhinorrhea, nasal itching, sneezing, and post nasal drip. Subjects
must have an average TSS baseline score of at least 8 on the S5 Subject Diary.

4. Prior to study drug administration, subjects' good health will be confirmed by medical
history & physical examination, including pregnancy test (urine dip) before study
inception.

5. Allergic hypersensitivity will be confirmed by the physician or well established
patient medical history.

6. Subject's compliance with requisite run-in period for the individual will be confirmed
by the investigator/designee.

Exclusion Criteria:

1. Pregnancy or lactation.

2. Immunotherapy unless at stable maintenance dose.

3. Presence of a medical condition that might interfere with treatment evaluation or
require a change in therapy including but not limited to high blood pressure or
urinary retention problems.

4. Alcohol dependence.

5. Use of any other investigational drug in the previous month.

6. Subjects presenting with asthma requiring corticosteroid treatment.

7. Subjects with multiple drug allergies.

8. Subjects known to have an idiosyncratic reaction to any of the ingredients in IMP.

9. Subject who has used any investigational drugs within 30 days of the screening visit.

10. Subject who is participating in any other clinical study.

11. Subject who is unable to meet washout requirements.

12. Subject with clinically significant abnormal vital sign or laboratory value that
precludes participation.

13. Subjects with any family relationship to Sponsor, Investigator, or staff of Sponsor or
Investigator.

14. A URI within 4 weeks of study inception.

15. Subjects taking beta blockers or tri-cyclic antidepressants will not be allowed to
participate in the study.