Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
37 participants
INTERVENTIONAL
2019-06-04
2020-11-27
Brief Summary
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Detailed Description
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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)).
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
QUADRUPLE
Study Groups
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BLS-M22 or Placebo 500mg group
Single Ascending Dose (SAD): BLS-M22 500mg or Placebo 500mg (n=9; BLS-M22=7, Placebe=2) Oral Administration
BLS-M22
BLS-M22 250mg/capsule
Placebo
BLS-M22 placebo 250mg/capsule
BLS-M22 or Placebo 1,000mg group
Single Ascending Dose (SAD): BLS-M22 1,000mg or Placebo 1,000mg (n=9; BLS-M22=7, Placebe=2) Oral Administration
BLS-M22
BLS-M22 250mg/capsule
Placebo
BLS-M22 placebo 250mg/capsule
BLS-M22 or Placebo 2,000mg group
Single Ascending Dose (SAD): BLS-M22 2,000mg or Placebo 2,000mg (n=9; BLS-M22=7, Placebe=2) Oral Administration
BLS-M22
BLS-M22 250mg/capsule
Placebo
BLS-M22 placebo 250mg/capsule
Multiple Ascending Dose group
Multiple Ascending Dose (MAD): BLS-M22 2,000mg or Placebo 2,000mg(n=10; BLS-M22=8 or Placebo=2) Oral Administration
BLS-M22
BLS-M22 250mg/capsule
Placebo
BLS-M22 placebo 250mg/capsule
Interventions
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BLS-M22
BLS-M22 250mg/capsule
Placebo
BLS-M22 placebo 250mg/capsule
Eligibility Criteria
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Inclusion Criteria
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
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
19 Years
55 Years
ALL
Yes
Sponsors
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BioLeaders Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Doyoung Lee, PhD
Role: STUDY_DIRECTOR
BioLeaders corp
Locations
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BioLeaders Co., Ltd.
Gyeonggi-do, Yongin-si, South Korea
Countries
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Other Identifiers
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BLS-M22-101
Identifier Type: -
Identifier Source: org_study_id
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