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NCT03789734
Safety Study of BLS-M22 in Healthy Volunteers
Phase 1 trial testing BLS-M22 in Muscular Dystrophy, Duchenne in 37 participants. Completed in 27 November 2020.
23 April 2020
Quick facts
| Lead sponsor | BioLeaders Corporation |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | sequential |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 37 |
| Start date | 4 June 2019 |
| Primary completion | 23 April 2020 |
| Estimated completion | 27 November 2020 |
| Sites | 1 location across South Korea |
Drugs / interventions tested
- BLS-M22 — full drug profile →
- Placebo
Conditions studied
- Muscular Dystrophy, Duchenne — all drugs for Muscular Dystrophy, Duchenne →
Sponsor
BioLeaders Corporation — full company profile →
Who can join
Adults 19 to 55, any sex, with Muscular Dystrophy, Duchenne. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Therapeutic applications and challenges in myostatin inhibition for enhanced skeletal muscle mass and functions.
Wetzlich B, Nyakundi BB, Yang J. · · 2025 · cited 37× · PMID 39340593 · DOI 10.1007/s11010-024-05120-y -
Myostatin Is a Quantifiable Biomarker for Monitoring Pharmaco-gene Therapy in Duchenne Muscular Dystrophy.
Mariot V, Le Guiner C, Barthélémy I, Montus M, et al · · 2020 · cited 22× · PMID 32695843 · DOI 10.1016/j.omtm.2020.06.016
Verify or expand the search:
- PubMed search for NCT03789734
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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- NCT03992430 — A Study to Compare Safety and Efficacy of High Doses of Eteplirsen in Participants With Duchenne Muscular Dystrophy (DMD · Phase 3 · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03789734 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by BioLeaders Corporation
- Last refreshed: 22 April 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03789734.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing