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

Study Overview
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Brief Summary
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The primary objective of this study is to assess the safety and tolerability of STMC-103H compared to placebo in allergic subjects who are otherwise healthy.

Detailed Description
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This is a first-in-human trial of this live biotherapeutic product. The primary objective is to assess safety and tolerability in allergic subjects who are otherwise healthy, with twice daily dosing in descending age groups.

Official Title
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A Phase 1b, Multi-centered, Randomized, Double-blind, Placebo-controlled, Parallel Group, Three Sequential Part Study of STMC-103H in Multi-Sensitized Allergic Subjects Who Are Otherwise Healthy

Conditions
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Atopic Immunoglobulin E-Mediated Allergic Disorder

Intervention / Treatment
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* Biological: STMC-103H
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Voluntary informed consent from subject or legally acceptable representative and/or child assent from the subject (as applicable). For part 1, subjects of 18 years to 40 years of age at the timing of the signature on the informed consent. For part 2, subjects of 12 years to 17 years of age at the timing of the signature on the informed consent. For part 3, subjects of 2 years to 11 years of age at the timing of the signature on the informed consent. Good health and free of significant diseases or clinically significant abnormal findings on physical exam and laboratory evaluations. No history or presence of gastrointestinal, hepatic, or renal disease/disorder. History of allergic disease confirmed by 2 or more episodes in past 5 years. Positive skin prick test to two or more common allergens. Subjects who are of childbearing potential must agree to remain abstinent from heterosexual activity or agree to use (or have their partner use) acceptable contraception to prevent pregnancy within projected duration of the trial. 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.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Patients will be randomized into two arms in three sequential age-descending cohorts: Part 1: 18-40 years of age Part 2: 12-17 years of age Part 3: 2-11 years of age
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: STMC-103H<br>Oral administration of STMC-103H twice daily, randomized 3:1 (STMC-103H:Placebo) in three age-descending groups: Part 1: 20 subjects 18-40 years of age Part 2: 20 subjects, 12-17 years of age Part 3: 20 subjects, 2-11 years of age | Biological: STMC-103H<br>* Live bacterial product<br>|
| Placebo Comparator: Placebo<br>Oral administration of placebo twice daily, randomized 3:1 (STMC-103H:Placebo) in three age-descending groups: Part 1: 20 subjects 18-40 years of age Part 2: 20 subjects, 12-17 years of age Part 3: 20 subjects, 2-11 years of age | Biological: Placebo<br>* Inactive placebo substance<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with treatment-related adverse events (AEs) assessed as mild, moderate and severe, from baseline to day 29. | All adverse events (AEs) recorded during the study through the date of randomization up to 28 days after the last dose of study drug will analyzed. Treatment-emergent AEs (TEAEs), defined as any AE that starts or increases in severity after the first dose of STMC-103H or placebo, will be summarized. The total number of reported AEs will also be summarized. | From baseline to day 57 | 
| Incidence of abnormal laboratory test results from baseline to day 29 | The change in laboratory results from baseline to day 29 in multi-sensitized (to two or more allergens) subjects who are otherwise healthy and who have completed BID dosing of STMC-103H or placebo for 28 days | From baseline to day 29 | 
| Change in blood pressure from baseline to day 57 | Observed values of blood pressure obtained at screening and study Days 1, 8, 15, 22, 29, 43, and 57) and corresponding changes from baseline (Day 1) will be listed and summarized by descriptive statistics by study part and visit. | From baseline to day 57 | 
| Change in respiration rate from baseline to day 57 | Observed values of respiration rate obtained at screening and study Days 1, 8, 15, 22, 29, 43, and 57) and corresponding changes from baseline (Day 1) will be listed and summarized by descriptive statistics by study part and visit. | From baseline to day 57 | 
| Change in heart rate from baseline to day 57 | Observed values of heart rate obtained at screening and study Days 1, 8, 15, 22, 29, 43, and 57) and corresponding changes from baseline (Day 1) will be listed and summarized by descriptive statistics by study part and visit. | From baseline to day 57 |