Safety Study of BLS-M22 in Healthy Volunteers

Phase 1

Completed

• Conditions: Muscular Dystrophy, Duchenne
• Interventions: Biological: BLS-M22; Other: Placebo

• Registration Number: NCT03789734
• Lead Sponsor: BioLeaders Corporation

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)).

Study Timeline

• Study First Submitted: 2018-12-12
• Study First Submitted QC: 2018-12-26
• Study First Posted: 2018-12-31
• Study Start: 2019-06-04
• Primary Completion: 2020-04-23
• Study Completion: 2020-11-27
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-21
• Last Update Posted: 2021-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
BLS-M22 or Placebo 500mg group	Placebo	Single Ascending Dose (SAD): BLS-M22 500mg or Placebo 500mg (n=9; BLS-M22=7, Placebe=2) Oral Administration
Multiple Ascending Dose group	BLS-M22	Multiple Ascending Dose (MAD): BLS-M22 2,000mg or Placebo 2,000mg(n=10; BLS-M22=8 or Placebo=2) Oral Administration
Multiple Ascending Dose group	Placebo	Multiple Ascending Dose (MAD): BLS-M22 2,000mg or Placebo 2,000mg(n=10; BLS-M22=8 or Placebo=2) Oral Administration
BLS-M22 or Placebo 500mg group	BLS-M22	Single Ascending Dose (SAD): BLS-M22 500mg or Placebo 500mg (n=9; BLS-M22=7, Placebe=2) Oral Administration
BLS-M22 or Placebo 2,000mg group	Placebo	Single Ascending Dose (SAD): BLS-M22 2,000mg or Placebo 2,000mg (n=9; BLS-M22=7, Placebe=2) Oral Administration
BLS-M22 or Placebo 1,000mg group	Placebo	Single Ascending Dose (SAD): BLS-M22 1,000mg or Placebo 1,000mg (n=9; BLS-M22=7, Placebe=2) Oral Administration
BLS-M22 or Placebo 1,000mg group	BLS-M22	Single Ascending Dose (SAD): BLS-M22 1,000mg or Placebo 1,000mg (n=9; BLS-M22=7, Placebe=2) Oral Administration
BLS-M22 or Placebo 2,000mg group	BLS-M22	Single Ascending Dose (SAD): BLS-M22 2,000mg or Placebo 2,000mg (n=9; BLS-M22=7, Placebe=2) Oral Administration

Primary Outcome Measures

Name	Time	Method
Adverse events	up to 4-5 weeks	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Secondary Outcome Measures

Name	Time	Method
AUClast	From 0 hours to 24 hours	Evaluation of the pharmacokinetic properties after administration of BLS-M22
Immunogenicity(Myostatin specific IgG level in serum)	up to 4-5 weeks	Evaluation of the immunogenicity after administration of BLS-M22

Trial Locations

Locations (1)

BioLeaders Co., Ltd.; 🇰🇷 Gyeonggi-do, Yongin-si, Korea, Republic of