drugset / Trial / NCT07122648

Phase 2 Trial to Evaluate the Efficacy, Safety of Allogeneic Mitochondria (PN-101) in Patients With Refractory Polymyositis or Dermatomyositis

NCT07122648 ↗

Phase 2 Not yet recruiting 36 enrolled Paean Biotechnology Inc.
RandomizedParallel-groupDouble-blindTreatment

Summary

The efficacy of PN-101 in subjects with polymyositis or dermatomyositis will be evaluated at Week 12 using IMACS-TIS in comparison with the placebo control group. The safety and efficacy will be evaluated following administration of PN-101 to subjects with polymyositis or dermatomyositis, in comparison with the placebo group

Timeline

Start
2025-12
Primary completion
2027-04
Completion
2027-04

Drugs

EvaluationDrugModalityDoseRoute
Subject PN-101 Unknown 300 ug Intravenous
Subject PN-101 Unknown 600 ug Intravenous

Indications