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Safety Study of BLS-M22 in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03789734
Recruitment Status : Recruiting
First Posted : December 31, 2018
Last Update Posted : February 7, 2020
Sponsor:
Information provided by (Responsible Party):
BioLeaders Corporation

Tracking Information
First Submitted Date  ICMJE December 12, 2018
First Posted Date  ICMJE December 31, 2018
Last Update Posted Date February 7, 2020
Actual Study Start Date  ICMJE June 4, 2019
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 1, 2019)
Adverse events [ Time Frame: up to 4-5 weeks ]
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Original Primary Outcome Measures  ICMJE
 (submitted: December 26, 2018)
Adverse events [ Time Frame: up to 4-5 weeks ]
Evaluation of the safety of BLS-M22 in 37 healthy volunteers.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 1, 2019)
  • AUClast [ Time Frame: From 0 hours to 24 hours ]
    Evaluation of the pharmacokinetic properties after administration of BLS-M22
  • Immunogenicity(Myostatin specific IgG level in serum) [ Time Frame: up to 4-5 weeks ]
    Evaluation of the immunogenicity after administration of BLS-M22
Original Secondary Outcome Measures  ICMJE
 (submitted: December 26, 2018)
  • AUClast [ Time Frame: From 0 hours to 24 hours ]
    Evaluation of the pharmacokinetic properties after administration of BLS-M22
  • Myostatin specific IgG in serum [ Time Frame: up to 4-5 weeks ]
    Evaluation of the immunogenicity after administration of BLS-M22
Current Other Pre-specified Outcome Measures
 (submitted: December 26, 2018)
Changes in muscle mass after Administration [ Time Frame: up to 4-5 weeks ]
Evaluation of the efficacy after Administraion of BLS-M22
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Safety Study of BLS-M22 in Healthy Volunteers
Official Title  ICMJE 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
Brief Summary BLS-M22 is being developed as an anti-myotatin 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.
Detailed Description

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)).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Muscular Dystrophy, Duchenne
Intervention  ICMJE
  • Biological: BLS-M22
    BLS-M22 250mg/capsule
  • Other: Placebo
    BLS-M22 placebo 250mg/capsule
Study Arms  ICMJE
  • Experimental: BLS-M22 or Placebo 500mg group
    Single Ascending Dose (SAD): BLS-M22 500mg or Placebo 500mg (n=9; BLS-M22=7, Placebe=2) Oral Administration
    Interventions:
    • Biological: BLS-M22
    • Other: Placebo
  • Experimental: BLS-M22 or Placebo 1,000mg group
    Single Ascending Dose (SAD): BLS-M22 1,000mg or Placebo 1,000mg (n=9; BLS-M22=7, Placebe=2) Oral Administration
    Interventions:
    • Biological: BLS-M22
    • Other: Placebo
  • Experimental: BLS-M22 or Placebo 2,000mg group
    Single Ascending Dose (SAD): BLS-M22 2,000mg or Placebo 2,000mg (n=9; BLS-M22=7, Placebe=2) Oral Administration
    Interventions:
    • Biological: BLS-M22
    • Other: Placebo
  • Experimental: Multiple Ascending Dose group
    Multiple Ascending Dose (MAD): BLS-M22 2,000mg or Placebo 2,000mg(n=10; BLS-M22=8 or Placebo=2) Oral Administration
    Interventions:
    • Biological: BLS-M22
    • Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 26, 2018)
37
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2020
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Male and female subjects between 19-55 years of age
  2. BMI: 19~28kg/m2(male), 18~25kg/m2(female) at screening test
  3. Able to provide consent to participate and having signed an Informed Consent Form (ICF)
  4. The subjects can obey the demands of the scheme

Exclusion Criteria:

  1. Subject has a clinically significant disease or history of liver, kidney, cardiovascular system, endocrine system, musculoskeletal system, digestive system, respiratory system, neuropsychiatry, blood∙tumor system.
  2. Hypersensitive to the lactobacillus-containing food (such as yogurt) and the lactobacillus preparation and the investigational drug
  3. Subject has received a investigational drug or a bioequivalence study drug within 90 days of the randomization
  4. Subject has received steroids or other immunosuppressive drugs within 30 days of randomization
  5. Positive serum test results for hepatitis C virus, hepatitis B virus, HIV or syphilis
  6. Those who do not use of a medically acceptable method of contraception during the trial, or who plan to provide sperm
  7. Pregnant women
  8. Subject has genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
  9. Subject has abnormal clinical laboratory test results
  10. Any other ineligible condition at the discretion of the investigator that would be ineligible to participate the study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Jae Hyung Lee +82312809622 ext +82312809646 jhlee@bioleaders.com
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03789734
Other Study ID Numbers  ICMJE BLS-M22-101
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party BioLeaders Corporation
Study Sponsor  ICMJE BioLeaders Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Jae Hyung Lee BioLeaders corp
PRS Account BioLeaders Corporation
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP