Clinical trial NCT03789734: Safety Study of BLS-M22 in Healthy Volunteers
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Muscular Dystrophy, Duchenne
Lead sponsor: BioLeaders Corporation
Sponsor class: INDUSTRY
First posted: 2018-12-31
Enrollment: 37
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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 BLS-M22.

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 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)).

Eligibility criteria: 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

Primary outcomes:
measure: Adverse events
timeFrame: up to 4-5 weeks
Secondary outcomes:
measure: AUClast
timeFrame: From 0 hours to 24 hours
measure: Immunogenicity(Myostatin specific IgG level in serum)
timeFrame: up to 4-5 weeks
Other outcomes:
measure: Changes in muscle mass after Administration
timeFrame: up to 4-5 weeks
Locations:
city: Gyeonggi-do
country: Korea, Republic of
facility: BioLeaders Co., Ltd.
state: Yongin-si
Study officials:
affiliation: BioLeaders corp
name: Doyoung Lee, PhD
role: STUDY_DIRECTOR
References: