Muscular Dystrophy, DuchennePhase 1NCT03789734
Safety Study of BLS-M22 in Healthy Volunteers
A Phase 1 study testing BLS-M22 in people with Muscular Dystrophy, Duchenne, run by BioLeaders Corporation at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscular Dystrophy, Duchenne
- What is being tested?
- BLS-M22
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 37 participants
- Where
- 1 siteSouth Korea
- Study dates
- 4 Jun 2019to 27 Nov 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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)).
- Conditions
- Muscular Dystrophy, Duchenne
- Being tested
- BLS-M22, Placebo
- Medical subject headings
- Muscular Dystrophy, Duchenne
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BLS-M22Biological
BLS-M22 250mg/capsule
PlaceboOther
BLS-M22 placebo 250mg/capsule
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Biological: BLS-M22; Other: 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 Receives: Biological: BLS-M22; Other: 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 Receives: Biological: BLS-M22; Other: 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 Receives: Biological: BLS-M22; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: up to 4-5 weeks
Secondary outcomes (2)
AUClast
Evaluation of the pharmacokinetic properties after administration of BLS-M22
Measured: From 0 hours to 24 hours
Immunogenicity(Myostatin specific IgG level in serum)
Evaluation of the immunogenicity after administration of BLS-M22
Measured: up to 4-5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2018
- Study start4 Jun 2019
- Primary completion23 Apr 2020
- Study completion27 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscular Dystrophy, DuchenneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioLeaders Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Doyoung Lee, PhD, Study director, BioLeaders corp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03789734
- Sponsor's protocol ID
- BLS-M22-101
- Status last verified
- Apr 2021
- First submitted
- 12 Dec 2018
- Last updated
- 22 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03789734
- Acronym / sponsor ID
- BLS-M22-101
- Conditions
- Muscular Dystrophy, Duchenne
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- BioLeaders CorporationIndustry (pharma, biotech, devices)
- Study start
- 4 Jun 2019 (actual)
- Primary completion
- 23 Apr 2020 (actual)
- Study completion
- 27 Nov 2020 (actual)
- First posted
- 31 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| BLS-M22 or Placebo 500mg group | Experimental | Biological: BLS-M22, Other: PlaceboSingle Ascending Dose (SAD): BLS-M22 500mg or Placebo 500mg (n=9; BLS-M22=7, Placebe=2) Oral Administration |
| BLS-M22 or Placebo 1,000mg group | Experimental | Biological: BLS-M22, Other: PlaceboSingle 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 | Experimental | Biological: BLS-M22, Other: PlaceboSingle Ascending Dose (SAD): BLS-M22 2,000mg or Placebo 2,000mg (n=9; BLS-M22=7, Placebe=2) Oral Administration |
| Multiple Ascending Dose group | Experimental | Biological: BLS-M22, Other: PlaceboMultiple Ascending Dose (MAD): BLS-M22 2,000mg or Placebo 2,000mg(n=10; BLS-M22=8 or Placebo=2) Oral Administration |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BLS-M22BLS-M22 250mg/capsule | Biological | BLS-M22 or Placebo 1,000mg group, BLS-M22 or Placebo 2,000mg group, BLS-M22 or Placebo 500mg group, Multiple Ascending Dose group |
| PlaceboBLS-M22 placebo 250mg/capsule | Other | BLS-M22 or Placebo 1,000mg group, BLS-M22 or Placebo 2,000mg group, BLS-M22 or Placebo 500mg group, Multiple Ascending Dose group |
Primary outcome
Adverse events
Time frame: up to 4-5 weeks
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
2 secondary outcomes
AUClast
Time frame: From 0 hours to 24 hours
Immunogenicity(Myostatin specific IgG level in serum)
Time frame: up to 4-5 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Doyoung Lee, PhD study director
BioLeaders corp
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BLS-M22 in people with Muscular Dystrophy, Duchenne, run by BioLeaders Corporation at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (time frame: up to 4-5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2021.