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Safety Study of BLS-M22 in Healthy Volunteers

Primary Purpose

Muscular Dystrophy, Duchenne

Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
BLS-M22
Placebo
Sponsored by
BioLeaders Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Muscular Dystrophy, Duchenne

Eligibility Criteria

19 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • BioLeaders Co., Ltd.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

BLS-M22 or Placebo 500mg group

BLS-M22 or Placebo 1,000mg group

BLS-M22 or Placebo 2,000mg group

Multiple Ascending Dose group

Arm Description

Single Ascending Dose (SAD): BLS-M22 500mg or Placebo 500mg (n=9; BLS-M22=7, Placebe=2) Oral Administration

Single Ascending Dose (SAD): BLS-M22 1,000mg or Placebo 1,000mg (n=9; BLS-M22=7, Placebe=2) Oral Administration

Single Ascending Dose (SAD): BLS-M22 2,000mg or Placebo 2,000mg (n=9; BLS-M22=7, Placebe=2) Oral Administration

Multiple Ascending Dose (MAD): BLS-M22 2,000mg or Placebo 2,000mg(n=10; BLS-M22=8 or Placebo=2) Oral Administration

Outcomes

Primary Outcome Measures

Adverse events
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Secondary Outcome Measures

AUClast
Evaluation of the pharmacokinetic properties after administration of BLS-M22
Immunogenicity(Myostatin specific IgG level in serum)
Evaluation of the immunogenicity after administration of BLS-M22

Full Information

First Posted
December 12, 2018
Last Updated
April 21, 2021
Sponsor
BioLeaders Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT03789734
Brief Title
Safety Study of BLS-M22 in Healthy Volunteers
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
June 4, 2019 (Actual)
Primary Completion Date
April 23, 2020 (Actual)
Study Completion Date
November 27, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BioLeaders Corporation

4. Oversight

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

5. Study Description

Brief Summary
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.
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)).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscular Dystrophy, Duchenne

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BLS-M22 or Placebo 500mg group
Arm Type
Experimental
Arm Description
Single Ascending Dose (SAD): BLS-M22 500mg or Placebo 500mg (n=9; BLS-M22=7, Placebe=2) Oral Administration
Arm Title
BLS-M22 or Placebo 1,000mg group
Arm Type
Experimental
Arm Description
Single Ascending Dose (SAD): BLS-M22 1,000mg or Placebo 1,000mg (n=9; BLS-M22=7, Placebe=2) Oral Administration
Arm Title
BLS-M22 or Placebo 2,000mg group
Arm Type
Experimental
Arm Description
Single Ascending Dose (SAD): BLS-M22 2,000mg or Placebo 2,000mg (n=9; BLS-M22=7, Placebe=2) Oral Administration
Arm Title
Multiple Ascending Dose group
Arm Type
Experimental
Arm 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(s)
BLS-M22
Intervention Description
BLS-M22 250mg/capsule
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
BLS-M22 placebo 250mg/capsule
Primary Outcome Measure Information:
Title
Adverse events
Description
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame
up to 4-5 weeks
Secondary Outcome Measure Information:
Title
AUClast
Description
Evaluation of the pharmacokinetic properties after administration of BLS-M22
Time Frame
From 0 hours to 24 hours
Title
Immunogenicity(Myostatin specific IgG level in serum)
Description
Evaluation of the immunogenicity after administration of BLS-M22
Time Frame
up to 4-5 weeks
Other Pre-specified Outcome Measures:
Title
Changes in muscle mass after Administration
Description
Evaluation of the efficacy after Administraion of BLS-M22
Time Frame
up to 4-5 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Male and female subjects between 19-55 years of age BMI: 19~28kg/m2(male), 18~25kg/m2(female) at screening test Able to provide consent to participate and having signed an Informed Consent Form (ICF) The subjects can obey the demands of the scheme Exclusion Criteria: 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. Hypersensitive to the lactobacillus-containing food (such as yogurt) and the lactobacillus preparation and the investigational drug Subject has received a investigational drug or a bioequivalence study drug within 90 days of the randomization Subject has received steroids or other immunosuppressive drugs within 30 days of randomization Positive serum test results for hepatitis C virus, hepatitis B virus, HIV or syphilis Those who do not use of a medically acceptable method of contraception during the trial, or who plan to provide sperm Pregnant women Subject has genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption Subject has abnormal clinical laboratory test results Any other ineligible condition at the discretion of the investigator that would be ineligible to participate the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Doyoung Lee, PhD
Organizational Affiliation
BioLeaders corp
Official's Role
Study Director
Facility Information:
Facility Name
BioLeaders Co., Ltd.
City
Gyeonggi-do
State/Province
Yongin-si
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Safety Study of BLS-M22 in Healthy Volunteers

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