<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03819881</url>
  </required_header>
  <id_info>
    <org_study_id>STMC-103H-101</org_study_id>
    <nct_id>NCT03819881</nct_id>
  </id_info>
  <brief_title>A Phase 1b Study of STMC-103H in Multi-Sensitized Allergic Subjects Who Are Otherwise Healthy</brief_title>
  <official_title>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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Siolta Therapeutics, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Integrium</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Siolta Therapeutics, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of this study is to assess the safety and tolerability of STMC-103H&#xD;
      compared to placebo in allergic subjects who are otherwise healthy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a first-in-human trial of this live biotherapeutic product. The primary objective is&#xD;
      to assess safety and tolerability in allergic subjects who are otherwise healthy, with twice&#xD;
      daily dosing in descending age groups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">October 10, 2018</start_date>
  <completion_date type="Anticipated">November 2019</completion_date>
  <primary_completion_date type="Anticipated">November 2019</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <intervention_model_description>Patients will be randomized into two arms in three sequential age-descending cohorts:&#xD;
Part 1: 18-40 years of age Part 2: 12-17 years of age Part 3: 2-11 years of age</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>Double-blind</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Number of patients with treatment-related adverse events (AEs) assessed as mild, moderate and severe, from baseline to day 29.</measure>
    <time_frame>From baseline to day 57</time_frame>
    <description>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.&#xD;
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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of abnormal laboratory test results from baseline to day 29</measure>
    <time_frame>From baseline to day 29</time_frame>
    <description>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</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in blood pressure from baseline to day 57</measure>
    <time_frame>From baseline to day 57</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in respiration rate from baseline to day 57</measure>
    <time_frame>From baseline to day 57</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in heart rate from baseline to day 57</measure>
    <time_frame>From baseline to day 57</time_frame>
    <description>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.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Atopic Immunoglobulin E-Mediated Allergic Disorder</condition>
  <arm_group>
    <arm_group_label>STMC-103H</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Oral administration of STMC-103H twice daily, randomized 3:1 (STMC-103H:Placebo) in three age-descending groups:&#xD;
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</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Oral administration of placebo twice daily, randomized 3:1 (STMC-103H:Placebo) in three age-descending groups:&#xD;
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</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>STMC-103H</intervention_name>
    <description>Live bacterial product</description>
    <arm_group_label>STMC-103H</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Inactive placebo substance</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Voluntary informed consent from subject or legally acceptable representative and/or&#xD;
             child assent from the subject (as applicable).&#xD;
&#xD;
          -  For part 1, subjects of 18 years to 40 years of age at the timing of the signature on&#xD;
             the informed consent.&#xD;
&#xD;
          -  For part 2, subjects of 12 years to 17 years of age at the timing of the signature on&#xD;
             the informed consent.&#xD;
&#xD;
          -  For part 3, subjects of 2 years to 11 years of age at the timing of the signature on&#xD;
             the informed consent.&#xD;
&#xD;
          -  Good health and free of significant diseases or clinically significant abnormal&#xD;
             findings on physical exam and laboratory evaluations.&#xD;
&#xD;
          -  No history or presence of gastrointestinal, hepatic, or renal disease/disorder.&#xD;
&#xD;
          -  History of allergic disease confirmed by 2 or more episodes in past 5 years.&#xD;
&#xD;
          -  Positive skin prick test to two or more common allergens.&#xD;
&#xD;
          -  Subjects who are of childbearing potential must agree to remain abstinent from&#xD;
             heterosexual activity or agree to use (or have their partner use) acceptable&#xD;
             contraception to prevent pregnancy within projected duration of the trial.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence or history of any significant acute or chronic medical illness, except for&#xD;
             allergic disease.&#xD;
&#xD;
          -  BMI &gt; 32 kg/m2 at the time of signing consent.&#xD;
&#xD;
          -  Current or persistent moderate to sever asthma that requires use of control medication&#xD;
             (Step 3 or above, according to Asthma Step Program).&#xD;
&#xD;
          -  Presence of rhinitis secondary to causes other than allergy.&#xD;
&#xD;
          -  History of anaphylaxis.&#xD;
&#xD;
          -  Any known allergies to two or more of the following three antibiotics: Augmentin,&#xD;
             tetracycline, or bacitracin.&#xD;
&#xD;
          -  Inability to be venipunctured and/or tolerate venous access (Parts 1 and 2 only).&#xD;
&#xD;
          -  Consistent consumption of probiotics ≥ 2 days / week over multiple weeks within the 3&#xD;
             months prior to the study Baseline Visit.&#xD;
&#xD;
          -  Regular use of any of the following medications:&#xD;
&#xD;
               -  Intranasal or systemic corticosteroids (in 1 month prior to screening or during&#xD;
                  study)&#xD;
&#xD;
               -  Leukotriene modifiers (in 1 month prior to screening or during study)&#xD;
&#xD;
               -  Intranasal cromolyn (in 2 weeks prior to screening or during study)&#xD;
&#xD;
               -  Intranasal or systemic decongestants (in 3 days prior to screening or during&#xD;
                  study)&#xD;
&#xD;
               -  Cetirizine, fexofenadine, loratadine, desloratadine, hydroxyzine (in 10 days&#xD;
                  prior to screening or during study)&#xD;
&#xD;
               -  Intranasal antihistamines (in 3 days prior to screening or during study)&#xD;
&#xD;
               -  Other systemic antihistamines (in 3 days prior to screening or during study)&#xD;
&#xD;
          -  Allergies to excipients in the Investigational Product formulation.&#xD;
&#xD;
          -  Allergy to soy in any form.&#xD;
&#xD;
          -  Presently consuming alcohol more than 2 glasses per day or has history of alcohol&#xD;
             dependence or alcohol abuse during the past one year prior to screening.&#xD;
&#xD;
          -  Presently a smoker or ex-smoker with history of smoking (subject must abstain from&#xD;
             smoking throughout the study).&#xD;
&#xD;
          -  History or presence of significant recreational or illicit drug abuse in past 1 year.&#xD;
&#xD;
          -  Participation in another clinical study within 30 days prior to screening.&#xD;
&#xD;
          -  Use of any probiotic or prebiotic in the past 3 months prior to screening.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joel Neutel, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Orange County Research Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Elizabeth Chesnut</last_name>
    <phone>404-803-0358</phone>
    <email>echesnut@sioltatherapeutics.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Nikole Kimes, PhD</last_name>
    <phone>843-480-2637</phone>
    <email>nkimes@sioltatherapeutics.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Bensch Clinical Research LLC</name>
      <address>
        <city>Stockton</city>
        <state>California</state>
        <zip>95207</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sandra Vallery</last_name>
      <phone>209-951-6741</phone>
      <email>sandyval@aol.com</email>
    </contact>
    <investigator>
      <last_name>George W Bensch, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Orange County Research Center</name>
      <address>
        <city>Tustin</city>
        <state>California</state>
        <zip>92780</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ashley Castro</last_name>
      <phone>714-263-7328</phone>
      <email>ashley.castro@OCResearchCenter.com</email>
    </contact>
    <investigator>
      <last_name>Joel Neutel, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 10, 2019</study_first_submitted>
  <study_first_submitted_qc>January 24, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 29, 2019</study_first_posted>
  <last_update_submitted>January 24, 2019</last_update_submitted>
  <last_update_submitted_qc>January 24, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 29, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypersensitivity</mesh_term>
    <mesh_term>Hypersensitivity, Immediate</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>November 10, 2020</submitted>
    <returned>December 3, 2020</returned>
    <submitted>December 7, 2020</submitted>
    <returned>December 30, 2020</returned>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03819881
org study id: STMC-103H-101
nct id: NCT03819881
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Sequential Assignment
intervention 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
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Double-blind
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
description: 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.
measure: Incidence of abnormal laboratory test results from baseline to day 29
time frame: From baseline to day 29
description: 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
measure: Change in blood pressure from baseline to day 57
time frame: From baseline to day 57
description: 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.
measure: Change in respiration rate from baseline to day 57
time frame: From baseline to day 57
description: 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.
measure: Change in heart rate from baseline to day 57
time frame: From baseline to day 57
description: 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.
arm group label: STMC-103H
arm group type: Experimental
description: 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
arm group label: Placebo
arm group type: Placebo Comparator
description: 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
intervention type: Biological
intervention name: STMC-103H
description: Live bacterial product
arm group label: STMC-103H
intervention type: Biological
intervention name: Placebo
description: Inactive placebo substance
arm group label: Placebo
criteria: 
gender: All
minimum age: 2 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Joel Neutel, MD
role: Principal Investigator
affiliation: Orange County Research Center
last name: Elizabeth Chesnut
phone: 404-803-0358
email: echesnut@sioltatherapeutics.com
last name: Nikole Kimes, PhD
phone: 843-480-2637
email: nkimes@sioltatherapeutics.com
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Hypersensitivity
mesh term: Hypersensitivity, Immediate
sharing ipd: No
submitted: November 10, 2020
returned: December 3, 2020
submitted: December 7, 2020
returned: December 30, 2020