Muscular Dystrophy, Duchenne
Conditions
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)).
Interventions
OTHERPlacebo
BLS-M22 placebo 250mg/capsule
BIOLOGICALBLS-M22
BLS-M22 250mg/capsule
Sponsors
BioLeaders Corporation
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | up to 4-5 weeks | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AUClast | From 0 hours to 24 hours | Evaluation of the pharmacokinetic properties after administration of BLS-M22 |
| Immunogenicity(Myostatin specific IgG level in serum) | up to 4-5 weeks | Evaluation of the immunogenicity after administration of BLS-M22 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Changes in muscle mass after Administration | up to 4-5 weeks | Evaluation of the efficacy after Administraion of BLS-M22 |
Countries
South Korea
Outcome results
None listed