NCT07122648View on ClinicalTrials.gov

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

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

December 31, 2025

Primary Completion Date

April 30, 2027

Study Completion Date

April 30, 2027

Conditions
PolymyositisDermatomyositis
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.

Trial Locations (5)

14353

Chung-Ang University Gwang Myeong Hospital, Gwangmyeong

02447

Kyung Hee University Medical Center, Seoul

03080

Seoul National University, Seoul

04401

Soon Chun Hyang University Hospital Seoul, Seoul

06973

Chung-Ang University Hospital, Seoul

Sponsors
All Listed Sponsors
lead

Paean Biotechnology Inc.

INDUSTRY