<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/NCT03789734</url>
  </required_header>
  <id_info>
    <org_study_id>BLS-M22-101</org_study_id>
    <nct_id>NCT03789734</nct_id>
  </id_info>
  <brief_title>Safety Study of BLS-M22 in Healthy Volunteers</brief_title>
  <official_title>A Dose Block-randomized, Double-blind, Placebo-controlled and Dose-escalation Phase I Clinical Trial to Evaluate Safety of BLS-M22 Following Single/Multiple Oral Administration in Healthy Adult Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>BioLeaders Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>BioLeaders Corporation</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      BLS-M22 is being developed as an anti-myostatin agent for the treatment of Duchenne Muscular&#xD;
      Dystrophy (Muscular Dystrophy). A total of 37 subjects participated in this study to confirm&#xD;
      the safety of BLS-M22.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a dose Block-randomized, Double-blind, Placebo-controlled and Dose-escalation&#xD;
      Phase I Clinical Trial to Evaluate Safety of BLS-M22.&#xD;
&#xD;
      The single ascending dose group participated in 9 patients in each group(500mg, 1,000mg,&#xD;
      2000mg/BLS-M22 or Placebo(n=7:2)). The multiple ascending dose group participated in 10&#xD;
      patients(determined dose in SAD/BLS-M22 or Placebo(n=8:2)).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 4, 2019</start_date>
  <completion_date type="Actual">November 27, 2020</completion_date>
  <primary_completion_date type="Actual">April 23, 2020</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Adverse events</measure>
    <time_frame>up to 4-5 weeks</time_frame>
    <description>Number of participants with treatment-related adverse events as assessed by CTCAE v4.0</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>AUClast</measure>
    <time_frame>From 0 hours to 24 hours</time_frame>
    <description>Evaluation of the pharmacokinetic properties after administration of BLS-M22</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immunogenicity(Myostatin specific IgG level in serum)</measure>
    <time_frame>up to 4-5 weeks</time_frame>
    <description>Evaluation of the immunogenicity after administration of BLS-M22</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Changes in muscle mass after Administration</measure>
    <time_frame>up to 4-5 weeks</time_frame>
    <description>Evaluation of the efficacy after Administraion of BLS-M22</description>
  </other_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">37</enrollment>
  <condition>Muscular Dystrophy, Duchenne</condition>
  <arm_group>
    <arm_group_label>BLS-M22 or Placebo 500mg group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single Ascending Dose (SAD): BLS-M22 500mg or Placebo 500mg (n=9; BLS-M22=7, Placebe=2) Oral Administration</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BLS-M22 or Placebo 1,000mg group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single Ascending Dose (SAD): BLS-M22 1,000mg or Placebo 1,000mg (n=9; BLS-M22=7, Placebe=2) Oral Administration</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BLS-M22 or Placebo 2,000mg group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single Ascending Dose (SAD): BLS-M22 2,000mg or Placebo 2,000mg (n=9; BLS-M22=7, Placebe=2) Oral Administration</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Multiple Ascending Dose group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Multiple Ascending Dose (MAD): BLS-M22 2,000mg or Placebo 2,000mg(n=10; BLS-M22=8 or Placebo=2) Oral Administration</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>BLS-M22</intervention_name>
    <description>BLS-M22 250mg/capsule</description>
    <arm_group_label>BLS-M22 or Placebo 1,000mg group</arm_group_label>
    <arm_group_label>BLS-M22 or Placebo 2,000mg group</arm_group_label>
    <arm_group_label>BLS-M22 or Placebo 500mg group</arm_group_label>
    <arm_group_label>Multiple Ascending Dose group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>BLS-M22 placebo 250mg/capsule</description>
    <arm_group_label>BLS-M22 or Placebo 1,000mg group</arm_group_label>
    <arm_group_label>BLS-M22 or Placebo 2,000mg group</arm_group_label>
    <arm_group_label>BLS-M22 or Placebo 500mg group</arm_group_label>
    <arm_group_label>Multiple Ascending Dose group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male and female subjects between 19-55 years of age&#xD;
&#xD;
          2. BMI: 19~28kg/m2(male), 18~25kg/m2(female) at screening test&#xD;
&#xD;
          3. Able to provide consent to participate and having signed an Informed Consent Form&#xD;
             (ICF)&#xD;
&#xD;
          4. The subjects can obey the demands of the scheme&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subject has a clinically significant disease or history of liver, kidney,&#xD;
             cardiovascular system, endocrine system, musculoskeletal system, digestive system,&#xD;
             respiratory system, neuropsychiatry, blood∙tumor system.&#xD;
&#xD;
          2. Hypersensitive to the lactobacillus-containing food (such as yogurt) and the&#xD;
             lactobacillus preparation and the investigational drug&#xD;
&#xD;
          3. Subject has received a investigational drug or a bioequivalence study drug within 90&#xD;
             days of the randomization&#xD;
&#xD;
          4. Subject has received steroids or other immunosuppressive drugs within 30 days of&#xD;
             randomization&#xD;
&#xD;
          5. Positive serum test results for hepatitis C virus, hepatitis B virus, HIV or syphilis&#xD;
&#xD;
          6. Those who do not use of a medically acceptable method of contraception during the&#xD;
             trial, or who plan to provide sperm&#xD;
&#xD;
          7. Pregnant women&#xD;
&#xD;
          8. Subject has genetic problems such as galactose intolerance, Lapp lactase deficiency or&#xD;
             glucose-galactose malabsorption&#xD;
&#xD;
          9. Subject has abnormal clinical laboratory test results&#xD;
&#xD;
         10. Any other ineligible condition at the discretion of the investigator that would be&#xD;
             ineligible to participate the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Doyoung Lee, PhD</last_name>
    <role>Study Director</role>
    <affiliation>BioLeaders corp</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>BioLeaders Co., Ltd.</name>
      <address>
        <city>Gyeonggi-do</city>
        <state>Yongin-si</state>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>December 12, 2018</study_first_submitted>
  <study_first_submitted_qc>December 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 31, 2018</study_first_posted>
  <last_update_submitted>April 21, 2021</last_update_submitted>
  <last_update_submitted_qc>April 21, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 22, 2021</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>Muscular Dystrophies</mesh_term>
    <mesh_term>Muscular Dystrophy, Duchenne</mesh_term>
  </condition_browse>
  <!-- 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/NCT03789734
org study id: BLS-M22-101
nct id: NCT03789734
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
BLS-M22 is being developed as an anti-myostatin agent for the treatment of Duchenne Muscular
      Dystrophy (Muscular Dystrophy). A total of 37 subjects participated in this study to confirm
      the safety of BLS-M22.
This study is a dose Block-randomized, Double-blind, Placebo-controlled and Dose-escalation
      Phase I Clinical Trial to Evaluate Safety of BLS-M22.

      The single ascending dose group participated in 9 patients in each group(500mg, 1,000mg,
      2000mg/BLS-M22 or Placebo(n=7:2)). The multiple ascending dose group participated in 10
      patients(determined dose in SAD/BLS-M22 or Placebo(n=8:2)).
allocation: Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Adverse events
time frame: up to 4-5 weeks
description: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
measure: AUClast
time frame: From 0 hours to 24 hours
description: Evaluation of the pharmacokinetic properties after administration of BLS-M22
measure: Immunogenicity(Myostatin specific IgG level in serum)
time frame: up to 4-5 weeks
description: Evaluation of the immunogenicity after administration of BLS-M22
measure: Changes in muscle mass after Administration
time frame: up to 4-5 weeks
description: Evaluation of the efficacy after Administraion of BLS-M22
arm group label: BLS-M22 or Placebo 500mg group
arm group type: Experimental
description: Single Ascending Dose (SAD): BLS-M22 500mg or Placebo 500mg (n=9; BLS-M22=7, Placebe=2) Oral Administration
arm group label: BLS-M22 or Placebo 1,000mg group
arm group type: Experimental
description: Single Ascending Dose (SAD): BLS-M22 1,000mg or Placebo 1,000mg (n=9; BLS-M22=7, Placebe=2) Oral Administration
arm group label: BLS-M22 or Placebo 2,000mg group
arm group type: Experimental
description: Single Ascending Dose (SAD): BLS-M22 2,000mg or Placebo 2,000mg (n=9; BLS-M22=7, Placebe=2) Oral Administration
arm group label: Multiple Ascending Dose group
arm group type: Experimental
description: Multiple Ascending Dose (MAD): BLS-M22 2,000mg or Placebo 2,000mg(n=10; BLS-M22=8 or Placebo=2) Oral Administration
intervention type: Biological
intervention name: BLS-M22
description: BLS-M22 250mg/capsule
arm group label: BLS-M22 or Placebo 1,000mg group
arm group label: BLS-M22 or Placebo 2,000mg group
arm group label: BLS-M22 or Placebo 500mg group
arm group label: Multiple Ascending Dose group
intervention type: Other
intervention name: Placebo
description: BLS-M22 placebo 250mg/capsule
arm group label: BLS-M22 or Placebo 1,000mg group
arm group label: BLS-M22 or Placebo 2,000mg group
arm group label: BLS-M22 or Placebo 500mg group
arm group label: Multiple Ascending Dose group
criteria: 
gender: All
minimum age: 19 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Doyoung Lee, PhD
role: Study Director
affiliation: BioLeaders corp
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Muscular Dystrophies
mesh term: Muscular Dystrophy, Duchenne