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Safety Study of BLS-M22 in Healthy Volunteers
study id #: NCT03789734
condition: Muscular Dystrophy, Duchenne
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.
intervention: BLS-M22, Placebo
mechanism of action: Anti-myostatin to promote muscle growth
last updated: November 14, 2020
start date: June 4, 2019
estimated completion: June 2020
phase of development: Phase 1
size / enrollment: 37
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, 1000mg, 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)).
- Adverse events [ Time Frame: up to 4-5 weeks ]
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
- AUClast [ Time Frame: From 0 hours to 24 hours ]
Evaluation of the pharmacokinetic properties after administration of BLS-M22
- Immunogenicity(Myostatin specific IgG level in serum) [ Time Frame: up to 4-5 weeks ]
Evaluation of the immunogenicity after administration of BLS-M22
• Eligible Sexes: all
• 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
• 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 an 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
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