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)).

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