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A Study to Evaluate the Safety, Tolerability and Efficacy in Patients With Burn(s)

NCT06440239 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-07-05

No results posted yet for this study

Summary

For Phase 1, researchers will explore the safety, and tolerability of PMS-101 and determine the recommended Phase 2 dose (RP2D) using the donor site.

For Phase 2a, researchers will compare PMS-101 to a standard-of-care to see if PMS-101 works to treat mid-dermal burns.

Conditions

  • Burns
  • Burn Degree Second

Interventions

DRUG

PMS-101

PMS-101

OTHER

Standard treatment

Standard treatment according to physicians

Sponsors & Collaborators

  • Primoris Therapeutics

    lead INDUSTRY

Principal Investigators

  • Joanneke Joanneke, Dr · The Concord Repatriation General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-01
Primary Completion
2025-02-28
Completion
2025-02-28

Countries

  • Australia

Study Locations

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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 NCT06440239 on ClinicalTrials.gov