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Safety Study of BLS-M22 in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT03789734
Recruitment Status : Not yet recruiting
First Posted : December 31, 2018
Last Update Posted : January 4, 2019
Sponsor:
Information provided by (Responsible Party):
BioLeaders Corporation

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.

Condition or disease Intervention/treatment Phase
Muscular Dystrophy, Duchenne Biological: BLS-M22 Other: Placebo Phase 1

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)).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 37 participants
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Estimated Study Start Date : March 2019
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : December 2019


Arm Intervention/treatment
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
Biological: BLS-M22
BLS-M22 250mg/capsule

Other: Placebo
BLS-M22 placebo 250mg/capsule

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
Biological: BLS-M22
BLS-M22 250mg/capsule

Other: Placebo
BLS-M22 placebo 250mg/capsule

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
Biological: BLS-M22
BLS-M22 250mg/capsule

Other: Placebo
BLS-M22 placebo 250mg/capsule

Experimental: Multiple Ascending Dose group
Multiple Ascending Dose (MAD): TBD, under MTD(BLS-M22 or Placebo) Oral Administration
Biological: BLS-M22
BLS-M22 250mg/capsule

Other: Placebo
BLS-M22 placebo 250mg/capsule




Primary Outcome Measures :
  1. Adverse events [ Time Frame: up to 4-5 weeks ]
    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0


Secondary Outcome Measures :
  1. AUClast [ Time Frame: From 0 hours to 24 hours ]
    Evaluation of the pharmacokinetic properties after administration of BLS-M22

  2. Immunogenicity(Myostatin specific IgG level in serum) [ Time Frame: up to 4-5 weeks ]
    Evaluation of the immunogenicity after administration of BLS-M22


Other Outcome Measures:
  1. Changes in muscle mass after Administration [ Time Frame: up to 4-5 weeks ]
    Evaluation of the efficacy after Administraion of BLS-M22



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Ages Eligible for Study:   19 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03789734


Contacts
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Contact: Cho Rong Park +82312809646 ext +82312809646 crpark@bioleaders.co.kr

Locations
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Korea, Republic of
Bioleaders corp Not yet recruiting
Gyeonggi-do, Yongin-si, Korea, Republic of
Contact: Jae Hyung Lee    +82-31-280-9622    jhlee@bioleaders.co.kr   
Sponsors and Collaborators
BioLeaders Corporation
Investigators
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Study Director: Jae Hyung Lee BioLeaders corp

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Responsible Party: BioLeaders Corporation
ClinicalTrials.gov Identifier: NCT03789734     History of Changes
Other Study ID Numbers: BLS-M22-101
First Posted: December 31, 2018    Key Record Dates
Last Update Posted: January 4, 2019
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Muscular Dystrophies
Muscular Dystrophy, Duchenne
Muscular Disorders, Atrophic
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Genetic Diseases, Inborn
Genetic Diseases, X-Linked