NCT03789734

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: BioLeaders Corporation · Industry
• Sex: All
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

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.

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

Interventions

Type	Name	Description
BIOLOGICAL	BLS-M22	BLS-M22 250mg/capsule
OTHER	Placebo	BLS-M22 placebo 250mg/capsule

Timeline

• Start date: 2019-06-04
• Primary completion: 2020-04-23
• Completion: 2020-11-27
• First posted: 2018-12-31
• Last updated: 2021-04-22

Locations

1 site across 1 country: South Korea