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

NCT06440239 | Not Yet Recruiting Phase 1

• 1 other identifier: PMS-101-A001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Tolerability assessed by dose-limiting toxicity (Phase 1)

  Day7, Day9, Day11, Day14, Day17, Day21, Day28, Day56

• Time to complete healing of wound site (Phase 2a)

  Day7, Day9, Day11, Day14, Day17, Day21, Day28, Day56, Day84

Study Arms (2)

Investigational Product

EXPERIMENTAL

PMS-101

Drug: PMS-101

Control

OTHER

Standard of care or treatment

Other: Standard treatment

Interventions

PMS-101 DRUG

PMS-101

Investigational Product

Standard treatment OTHER

Standard treatment according to physicians

Control

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The combined TBSA of all burns is 10% or less.
• Nonsmoker and must not have used any tobacco products within 2 months prior to Screening.
• Phase 1 only: Participants with TBSA \< 10% who will undergo autologous skin grafting.
• Phase 2a only: Participants with dermal burns who are within 5 days from the date of wound and will be enrolled.
• Phase 1 only: Those who have confirmed at least 1 donor wound site with an even distribution of depth and extent of maximum 1% TBSA as judged by the Investigator.
• Phase 2a only: Those who have confirmed at least 2 dermal burn sites with similar depth and extent of 50 cm2 or more each as judged by the Investigator.

You may not qualify if:

• Those who are allergic to or have experienced hypersensitivity to any components of the IP or its excipients such as gelatin or hyaluronic acid ingredients.
• Those with the following conditions for burns at the time of Screening in clinical trials:
• Those who have suffered chemical or electrical burns (for Phase 2a only).
• Persons requiring tracheal intubation or tracheostomy due to severe inhalation burns.
• Those with burn wounds accompanied by trauma such as fractures or lacerations.
• Persons with purulent infection of burn wounds.
• Those who require treatment such as artificial mechanical ventilation, extracorporeal membrane oxygen therapy, or dialysis due to other concomitant diseases or conditions.
• History of or active bleeding or coagulation diseases (eg, hemophilia, von Willebrand's disease, thrombocytopenia, disseminated intravascular coagulation).
• History of or active autoimmune diseases (eg, systemic lupus erythematosus, rheumatoid arthritis, Sjögren's syndrome, Behcet's disease, and/or multiple sclerosis.
• History of or active cardiovascular disease including clinically significant arrhythmias, uncontrolled hypertension, coronary artery disease (CAD), and/or prolonged QT interval (QTc \> 450 msec for males and \> 470 msec for females).
• History of or active ischemic, hemorrhagic, or anatomical neurovascular disease including, but not limited to, trans ischemic attack, cerebrovascular accident, arterio-venous malformation, or brain aneurysm.
• History of or active peripheral vascular disease such as deep vein thrombosis, pulmonary embolism, chronic venous insufficiency, claudication, or lymphedema.
• History of active pulmonary diseases including chronic obstructive pulmonary disease, pulmonary fibrosis, moderate-to-severe sleep apnea, and moderate-to-severe asthma.
• Active malignancy, other than local subcutaneous squamous cell and basal cell carcinomas.
• History of immunosuppressive, chemotherapeutic, or radiation treatment within the last 12 months prior to Screening.

Sponsors & Collaborators

• Primoris Therapeutics: lead

Study Sites (1)

The Concord Repatriation General Hospital

Sydney, New South Wales, 2139, Australia

Location

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Joanneke Joanneke, Dr

  The Concord Repatriation General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joanneke Maitz, Dr

CONTACT

+61408865606; jo.maitz@skingineering.com.au

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2024
• First Posted: June 3, 2024
• Study Start: January 1, 2025
• Primary Completion: February 28, 2025
• Study Completion: February 28, 2025
• Last Updated: July 5, 2024

Record last verified: 2024-07

Locations

AU (1)