Safety Study of BLS-M22 in Healthy Volunteers

Muscular Dystrophy, Duchenne Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03789734
• Other study ID #: BLS-M22-101
• Status: Completed
• Phase: Phase 1
• Start date: June 4, 2019
• Est. completion date: November 27, 2020

Study information

• Verified date: April 2021
• Source: BioLeaders Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: November 27, 2020
• Est. primary completion date: April 23, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Muscular Dystrophies
• Muscular Dystrophy, Duchenne

Intervention

Biological:
• BLS-M22
BLS-M22 250mg/capsule

Other:
• Placebo
BLS-M22 placebo 250mg/capsule

Locations

Country	Name	City	State
Korea, Republic of	BioLeaders Co., Ltd.	Gyeonggi-do	Yongin-si

Sponsors (1)

Lead Sponsor	Collaborator
BioLeaders Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in muscle mass after Administration	Evaluation of the efficacy after Administraion of BLS-M22	up to 4-5 weeks
Primary	Adverse events	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	up to 4-5 weeks
Secondary	AUClast	Evaluation of the pharmacokinetic properties after administration of BLS-M22	From 0 hours to 24 hours
Secondary	Immunogenicity(Myostatin specific IgG level in serum)	Evaluation of the immunogenicity after administration of BLS-M22	up to 4-5 weeks