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

NCT ID: NCT03819881

Last Updated: 2019-01-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-10
• Study Completion Date: 2019-11-30

Brief Summary

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

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.

Conditions

Atopic Immunoglobulin E-Mediated Allergic Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

STMC-103H

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

Group Type: EXPERIMENTAL

STMC-103H

Intervention Type: BIOLOGICAL

Live bacterial product

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

Inactive placebo substance

Interventions

STMC-103H

Live bacterial product

Intervention Type: BIOLOGICAL

Placebo

Inactive placebo substance

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Integrium

INDUSTRY

Sponsor Role: collaborator

Siolta Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joel Neutel, MD

Role: PRINCIPAL_INVESTIGATOR

Orange County Research Center

Locations

Bensch Clinical Research LLC

Stockton, California, United States

Site Status: RECRUITING

Orange County Research Center

Tustin, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Elizabeth Chesnut

Role: CONTACT

echesnut@sioltatherapeutics.com

404-803-0358

Nikole Kimes, PhD

Role: CONTACT

nkimes@sioltatherapeutics.com

843-480-2637

Facility Contacts

Sandra Vallery

Role: primary

sandyval@aol.com

209-951-6741

Ashley Castro

Role: primary

ashley.castro@OCResearchCenter.com

714-263-7328

Other Identifiers

STMC-103H-101

Identifier Type: -

Identifier Source: org_study_id