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NOT YET RECRUITING
NCT07122648
PHASE2

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

Sponsor: Paean Biotechnology Inc.

View on ClinicalTrials.gov

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

Official title: A Prospective, Multi-center, Randomized, Double-blinded, Placebo-controlled, Parallel, Phase 2 Trial to Evaluate the Efficacy, Safety of PN-101(Mitochondria Isolated From Allogeneic Umbilical Cord-derived Mesenchymal Stem Cells) Single Dose in Patients With Refractory Polymyositis or Dermatomyositis

Key Details

Gender

All

Age Range

19 Years - Any

Study Type

INTERVENTIONAL

Enrollment

36

Start Date

2025-12

Completion Date

2027-04

Last Updated

2025-08-14

Healthy Volunteers

No

Interventions

BIOLOGICAL

placebo

Participants will receive a single IV dose of 300 µg of placebo

BIOLOGICAL

PN-101

Participants will receive a single IV dose of 300 µg of PN-101

BIOLOGICAL

PN-101

Participants will receive a single IV dose of 600 µg of PN-101.

Locations (5)

Chung-Ang University Gwang Myeong Hospital

Gwangmyeong, Gyeonggi-do, South Korea

Kyung Hee University Medical Center

Seoul, South Korea

Seoul National University

Seoul, South Korea

Soon Chun Hyang University Hospital Seoul

Seoul, South Korea

Chung-Ang University Hospital

Seoul, South Korea