Status:
COMPLETED
Safety Study of BLS-M22 in Healthy Volunteers
Lead Sponsor:
BioLeaders Corporation
Conditions:
Muscular Dystrophy, Duchenne
Eligibility:
All Genders
19-55 years
Phase:
PHASE1
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 ...
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 pat...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 4 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 27 2020
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT03789734
Start Date
June 4 2019
End Date
November 27 2020
Last Update
April 22 2021
Active Locations (1)
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1
BioLeaders Co., Ltd.
Gyeonggi-do, Yongin-si, South Korea