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

NCT03819881 | Unknown Phase 1 FDA Drug

• 1 other identifier: STMC-103H-101
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

STMC-103H

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

STMC-103H BIOLOGICAL

Live bacterial product

STMC-103H

Placebo BIOLOGICAL

Inactive placebo substance

Placebo

Eligibility Criteria

• Age: 2 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Siolta Therapeutics, Inc.: lead
• Integrium: collaborator

Study Sites (2)

Bensch Clinical Research LLC

Stockton, California, 95207, United States

RECRUITING

Orange County Research Center

Tustin, California, 92780, United States

RECRUITING

Study Officials

• Joel Neutel, MD

  Orange County Research Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elizabeth Chesnut

CONTACT

404-803-0358; echesnut@sioltatherapeutics.com

Nikole Kimes, PhD

CONTACT

843-480-2637; nkimes@sioltatherapeutics.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: January 10, 2019
• First Posted: January 29, 2019
• Study Start: October 10, 2018
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2019
• Last Updated: January 29, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)