Safety Study of BLS-M22 in Healthy Volunteers

Study Overview
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Brief Summary
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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
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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)).

Official Title
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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

Conditions
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Muscular Dystrophy, Duchenne

Intervention / Treatment
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* Biological: BLS-M22
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BLS-M22 or Placebo 500mg group<br>Single Ascending Dose (SAD): BLS-M22 500mg or Placebo 500mg (n=9; BLS-M22=7, Placebe=2) Oral Administration | Biological: BLS-M22<br>* BLS-M22 250mg/capsule<br>Other: Placebo<br>* BLS-M22 placebo 250mg/capsule<br>|
| Experimental: BLS-M22 or Placebo 1,000mg group<br>Single Ascending Dose (SAD): BLS-M22 1,000mg or Placebo 1,000mg (n=9; BLS-M22=7, Placebe=2) Oral Administration | Biological: BLS-M22<br>* BLS-M22 250mg/capsule<br>Other: Placebo<br>* BLS-M22 placebo 250mg/capsule<br>|
| Experimental: BLS-M22 or Placebo 2,000mg group<br>Single Ascending Dose (SAD): BLS-M22 2,000mg or Placebo 2,000mg (n=9; BLS-M22=7, Placebe=2) Oral Administration | Biological: BLS-M22<br>* BLS-M22 250mg/capsule<br>Other: Placebo<br>* BLS-M22 placebo 250mg/capsule<br>|
| Experimental: Multiple Ascending Dose group<br>Multiple Ascending Dose (MAD): BLS-M22 2,000mg or Placebo 2,000mg(n=10; BLS-M22=8 or Placebo=2) Oral Administration | Biological: BLS-M22<br>* BLS-M22 250mg/capsule<br>Other: Placebo<br>* BLS-M22 placebo 250mg/capsule<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | up to 4-5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUClast | Evaluation of the pharmacokinetic properties after administration of BLS-M22 | From 0 hours to 24 hours | 
| Immunogenicity(Myostatin specific IgG level in serum) | Evaluation of the immunogenicity after administration of BLS-M22 | up to 4-5 weeks |