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

NCT07122648 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2025-08-14

No results posted yet for this study

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

Conditions

  • Polymyositis
  • Dermatomyositis

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.

Sponsors & Collaborators

  • Paean Biotechnology Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-31
Primary Completion
2027-04-30
Completion
2027-04-30

Countries

  • South Korea

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07122648 on ClinicalTrials.gov