Safety Study of BLS-M22 in Healthy Volunteers

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

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.

Study Overview

• Status: Completed
• Conditions: Muscular Dystrophy, Duchenne
• Intervention / Treatment: Biological: BLS-M22; Other: Placebo

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 Type: Interventional
• Enrollment (Actual): 37
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Yongin-si
    • Gyeonggi-do, Yongin-si, Korea, Republic of
      • BioLeaders Co., Ltd.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Biological: BLS-M22; BLS-M22 250mg/capsule; Other: Placebo; BLS-M22 placebo 250mg/capsule
Experimental: 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	Biological: BLS-M22; BLS-M22 250mg/capsule; Other: Placebo; BLS-M22 placebo 250mg/capsule
Experimental: 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	Biological: BLS-M22; BLS-M22 250mg/capsule; Other: Placebo; BLS-M22 placebo 250mg/capsule
Experimental: 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	Biological: BLS-M22; BLS-M22 250mg/capsule; Other: Placebo; BLS-M22 placebo 250mg/capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	up to 4-5 weeks

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in muscle mass after Administration	Evaluation of the efficacy after Administraion of BLS-M22	up to 4-5 weeks

Collaborators and Investigators

• Sponsor: BioLeaders Corporation
• Investigators: Study Director: Doyoung Lee, PhD, BioLeaders corp

Study record dates

Study Major Dates

• Study Start (Actual): June 4, 2019
• Primary Completion (Actual): April 23, 2020
• Study Completion (Actual): November 27, 2020

Study Registration Dates

• First Submitted: December 12, 2018
• First Submitted That Met QC Criteria: December 26, 2018
• First Posted (Actual): December 31, 2018

Study Record Updates

• Last Update Posted (Actual): April 22, 2021
• Last Update Submitted That Met QC Criteria: April 21, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Genetic Diseases, Inborn; Genetic Diseases, X-Linked; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Muscular Disorders, Atrophic; Muscular Dystrophies; Muscular Dystrophy, Duchenne
• Other Study ID Numbers: BLS-M22-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No