Recruiting
Phase 1

STMC-103H

Sponsor:

Siolta Therapeutics, Inc.

Code:

NCT03819881

Conditions

Atopic Immunoglobulin E-Mediated Allergic Disorder

Eligibility Criteria

Sex: All

Age: 2 - 40

Healthy Volunteers: Accepted

Interventions

STMC-103H

Placebo

Study Details

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.

Conditions

Atopic Immunoglobulin E-Mediated Allergic Disorder

Study ID

NCT03819881

Start date

Oct 10, 2018

Status verified date

Jan, 2019

Completion date

Nov, 2019

Anticipated

Primary completion date

Nov, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2 - 40

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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

placebo comparator: 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

Interventions

STMC-103H

Live bacterial product

Placebo

Inactive placebo substance

Primary outcome measure

  • Number of patients with treatment-related adverse events (AEs) assessed as mild, moderate and severe, from baseline to day 29. [ Time Frame: From baseline to day 57 ]
  • Incidence of abnormal laboratory test results from baseline to day 29 [ Time Frame: From baseline to day 29 ]
  • Change in blood pressure from baseline to day 57 [ Time Frame: From baseline to day 57 ]
  • Change in respiration rate from baseline to day 57 [ Time Frame: From baseline to day 57 ]
  • Change in heart rate from baseline to day 57 [ Time Frame: From baseline to day 57 ]

Central Contacts and Locations

Central contacts

Elizabeth Chesnut

404-803-0358echesnut@sioltatherapeutics.com

Nikole Kimes, PhD

843-480-2637nkimes@sioltatherapeutics.com

Locations

Bensch Clinical Research LLC

Recruiting

Stockton, California, United States, 95207

Contacts

Sandra Vallery

209-951-6741sandyval@aol.com

Principal Investigator:

George W Bensch, MD

Orange County Research Center

Recruiting

Tustin, California, United States, 92780

Contacts

Ashley Castro

714-263-7328ashley.castro@OCResearchCenter.com

Principal Investigator:

Joel Neutel, MD

More Information

Sponsor

Siolta Therapeutics, Inc.

Last update posted

Jan 29, 2019

Last verified

Jan, 2019

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Siolta Therapeutics, Inc. on 2019-01-29.