A Phase 1b Study of STMC-103H in Multi-Sensitized Allergic Subjects Who Are Otherwise Healthy

Exclusion Criteria

• •Presence or history of any significant acute or chronic medical illness, except for allergic disease.
• •BMI \> 32 kg/m2 at the time of signing consent.
• •Current or persistent moderate to sever asthma that requires use of control medication (Step 3 or above, according to Asthma Step Program).
• •Presence of rhinitis secondary to causes other than allergy.
• •History of anaphylaxis.
• •Any known allergies to two or more of the following three antibiotics: Augmentin, tetracycline, or bacitracin.
• •Inability to be venipunctured and/or tolerate venous access (Parts 1 and 2 only).
• •Consistent consumption of probiotics ≥ 2 days / week over multiple weeks within the 3 months prior to the study Baseline Visit.
• •Regular use of any of the following medications:
• •* Intranasal or systemic corticosteroids (in 1 month prior to screening or during study)
• •* Leukotriene modifiers (in 1 month prior to screening or during study)
• •* Intranasal cromolyn (in 2 weeks prior to screening or during study)
• •* Intranasal or systemic decongestants (in 3 days prior to screening or during study)
• •* Cetirizine, fexofenadine, loratadine, desloratadine, hydroxyzine (in 10 days prior to screening or during study)
• •* Intranasal antihistamines (in 3 days prior to screening or during study)
• •* Other systemic antihistamines (in 3 days prior to screening or during study)
• •Allergies to excipients in the Investigational Product formulation.
• •Allergy to soy in any form.
• •Presently consuming alcohol more than 2 glasses per day or has history of alcohol dependence or alcohol abuse during the past one year prior to screening.
• •Presently a smoker or ex-smoker with history of smoking (subject must abstain from smoking throughout the study).
• •History or presence of significant recreational or illicit drug abuse in past 1 year.
• •Participation in another clinical study within 30 days prior to screening.
• •Use of any probiotic or prebiotic in the past 3 months prior to screening.