drugset / Trial / NCT02667483

Study of DS-5141b in Patients With Duchenne Muscular Dystrophy

NCT02667483 ↗

Phase 1/2 Completed 8 enrolled Daiichi Sankyo
NaSingle-groupOpen-labelTreatment

Summary

This is a phase I/II study to evaluate the safety, tolerability, efficacy, and pharmacokinetic (PK) profile of DS-5141b in patients with Duchenne muscular dystrophy (DMD) amenable to exon 45 skipping and to determine the dosage for subsequent studies.

Timeline

Start
2015-10
Primary completion
2020-10-20
Completion
2020-10-20

Drugs

EvaluationDrugModalityDoseRoute
Subject DS-5141b Unknown 0.1 mg/kg Subcutaneous
Subject DS-5141b Unknown 0.5 mg/kg Subcutaneous
Subject DS-5141b Unknown 2 mg/kg Subcutaneous
Subject DS-5141b Unknown 6 mg/kg Subcutaneous