NCT03789734

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jun 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 12, 2018

Completed
19 days until next milestone

First Posted

Study publicly available on registry

December 31, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

June 4, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 23, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 27, 2020

Completed
Last Updated

April 22, 2021

Status Verified

April 1, 2021

Enrollment Period

11 months

First QC Date

December 12, 2018

Last Update Submit

April 21, 2021

Conditions

Muscular Dystrophy, Duchenne

Outcome Measures

Primary Outcomes (1)

  • Adverse events

    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    up to 4-5 weeks

Secondary Outcomes (2)

  • AUClast

    From 0 hours to 24 hours

  • Immunogenicity(Myostatin specific IgG level in serum)

    up to 4-5 weeks

Other Outcomes (1)

  • Changes in muscle mass after Administration

    up to 4-5 weeks

Study Arms (4)

BLS-M22 or Placebo 500mg group

EXPERIMENTAL

Single Ascending Dose (SAD): BLS-M22 500mg or Placebo 500mg (n=9; BLS-M22=7, Placebe=2) Oral Administration

Biological: BLS-M22Other: Placebo

BLS-M22 or Placebo 1,000mg group

EXPERIMENTAL

Single Ascending Dose (SAD): BLS-M22 1,000mg or Placebo 1,000mg (n=9; BLS-M22=7, Placebe=2) Oral Administration

Biological: BLS-M22Other: Placebo

BLS-M22 or Placebo 2,000mg group

EXPERIMENTAL

Single Ascending Dose (SAD): BLS-M22 2,000mg or Placebo 2,000mg (n=9; BLS-M22=7, Placebe=2) Oral Administration

Biological: BLS-M22Other: Placebo

Multiple Ascending Dose group

EXPERIMENTAL

Multiple Ascending Dose (MAD): BLS-M22 2,000mg or Placebo 2,000mg(n=10; BLS-M22=8 or Placebo=2) Oral Administration

Biological: BLS-M22Other: Placebo

Interventions

BLS-M22BIOLOGICAL

BLS-M22 250mg/capsule

BLS-M22 or Placebo 1,000mg groupBLS-M22 or Placebo 2,000mg groupBLS-M22 or Placebo 500mg groupMultiple Ascending Dose group
PlaceboOTHER

BLS-M22 placebo 250mg/capsule

BLS-M22 or Placebo 1,000mg groupBLS-M22 or Placebo 2,000mg groupBLS-M22 or Placebo 500mg groupMultiple Ascending Dose group

Eligibility Criteria

Age19 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male and female subjects between 19-55 years of age
  • BMI: 19\~28kg/m2(male), 18\~25kg/m2(female) at screening test
  • Able to provide consent to participate and having signed an Informed Consent Form (ICF)
  • The subjects can obey the demands of the scheme

You may not qualify if:

  • 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.
  • Hypersensitive to the lactobacillus-containing food (such as yogurt) and the lactobacillus preparation and the investigational drug
  • Subject has received a investigational drug or a bioequivalence study drug within 90 days of the randomization
  • Subject has received steroids or other immunosuppressive drugs within 30 days of randomization
  • Positive serum test results for hepatitis C virus, hepatitis B virus, HIV or syphilis
  • Those who do not use of a medically acceptable method of contraception during the trial, or who plan to provide sperm
  • Pregnant women
  • Subject has genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
  • Subject has abnormal clinical laboratory test results
  • Any other ineligible condition at the discretion of the investigator that would be ineligible to participate the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BioLeaders Co., Ltd.

Gyeonggi-do, Yongin-si, South Korea

Location

MeSH Terms

Conditions

Muscular Dystrophy, Duchenne

Condition Hierarchy (Ancestors)

Muscular DystrophiesMuscular Disorders, AtrophicMuscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesGenetic Diseases, X-LinkedGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Doyoung Lee, PhD

    BioLeaders corp

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2018

First Posted

December 31, 2018

Study Start

June 4, 2019

Primary Completion

April 23, 2020

Study Completion

November 27, 2020

Last Updated

April 22, 2021

Record last verified: 2021-04

Locations

KR(1)