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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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3 May 2021 |
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Main ID: |
NCT03789734 |
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Date of registration:
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12/12/2018 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Safety Study of BLS-M22 in Healthy Volunteers
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Scientific title:
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A Dose Block-randomized, Double-blind, Placebo-controlled and Dose-escalation Phase I Clinical Trial to Evaluate Safety of BLS-M22 Following Single/Multiple Oral Administration in Healthy Adult Volunteers |
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Date of first enrolment:
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June 4, 2019 |
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Target sample size:
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37 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03789734 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 1
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Countries of recruitment
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Korea, Republic of
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Contacts
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Name:
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Doyoung Lee, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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BioLeaders corp |
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Key inclusion & exclusion criteria
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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
Age minimum:
19 Years
Age maximum:
55 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Muscular Dystrophy, Duchenne
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Intervention(s)
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Biological: BLS-M22
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Other: Placebo
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Primary Outcome(s)
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Adverse events
[Time Frame: up to 4-5 weeks]
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Secondary Outcome(s)
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AUClast
[Time Frame: From 0 hours to 24 hours]
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Immunogenicity(Myostatin specific IgG level in serum)
[Time Frame: up to 4-5 weeks]
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Secondary ID(s)
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BLS-M22-101
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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