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)).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
37
BioLeaders Co., Ltd.
Gyeonggi-do, Yongin-si, South Korea
Adverse events
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: up to 4-5 weeks
AUClast
Evaluation of the pharmacokinetic properties after administration of BLS-M22
Time frame: From 0 hours to 24 hours
Immunogenicity(Myostatin specific IgG level in serum)
Evaluation of the immunogenicity after administration of BLS-M22
Time frame: up to 4-5 weeks
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