A Study to Evaluate the Safety, Tolerability and Efficacy in Patients With Burn(s)
NCT ID: NCT06440239
Last Updated: 2024-07-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE1/PHASE2
40 participants
INTERVENTIONAL
2025-01-01
2025-02-28
Brief Summary
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For Phase 2a, researchers will compare PMS-101 to a standard-of-care to see if PMS-101 works to treat mid-dermal burns.
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Detailed Description
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Phase 2a is a double arm, open label, randomised study designed to assess the safety and efficacy of the dose recommended after the tolerability assessments of all participants enrolled in Phase 1 study.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Investigational Product
PMS-101
PMS-101
PMS-101
Control
Standard of care or treatment
Standard treatment
Standard treatment according to physicians
Interventions
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PMS-101
PMS-101
Standard treatment
Standard treatment according to physicians
Eligibility Criteria
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Inclusion Criteria
2. Nonsmoker and must not have used any tobacco products within 2 months prior to Screening.
3. Phase 1 only: Participants with TBSA \< 10% who will undergo autologous skin grafting.
4. Phase 2a only: Participants with dermal burns who are within 5 days from the date of wound and will be enrolled.
5. 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.
6. 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.
Exclusion Criteria
2. Those with the following conditions for burns at the time of Screening in clinical trials:
1. Those who have suffered chemical or electrical burns (for Phase 2a only).
2. Persons requiring tracheal intubation or tracheostomy due to severe inhalation burns.
3. Those with burn wounds accompanied by trauma such as fractures or lacerations.
4. Persons with purulent infection of burn wounds.
5. Those who require treatment such as artificial mechanical ventilation, extracorporeal membrane oxygen therapy, or dialysis due to other concomitant diseases or conditions.
3. History of or active bleeding or coagulation diseases (eg, hemophilia, von Willebrand's disease, thrombocytopenia, disseminated intravascular coagulation).
4. History of or active autoimmune diseases (eg, systemic lupus erythematosus, rheumatoid arthritis, Sjögren's syndrome, Behcet's disease, and/or multiple sclerosis.
5. 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).
6. 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.
7. History of or active peripheral vascular disease such as deep vein thrombosis, pulmonary embolism, chronic venous insufficiency, claudication, or lymphedema.
8. History of active pulmonary diseases including chronic obstructive pulmonary disease, pulmonary fibrosis, moderate-to-severe sleep apnea, and moderate-to-severe asthma.
9. Active malignancy, other than local subcutaneous squamous cell and basal cell carcinomas.
10. History of immunosuppressive, chemotherapeutic, or radiation treatment within the last 12 months prior to Screening.
11. History of type 1 diabetes or active type 2 diabetes.
12. History of severe endocrine disorders such as Cushing's disease, hypogonadism, and growth hormone deficiency.
13. History or presence of severe active acute or chronic liver disease (eg, cirrhosis), hepatic insufficiency defined as Child Pugh Class A or higher, nonalcoholic fatty liver disease (NAFLD), nonalcoholic steatohepatitis (NASH), general hepatic disease including serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 3 × the upper limit of normal.
14. Uncontrolled psychiatric disease including major depressive disorder, bipolar, anxiety disorder, or eating disorders such as bulimia.
15. Those with serious diseases or condition that the Investigator believes may affect wound healing, such as a malnourished, clinically significant vitamin and/or mineral deficiencies.
16. Positive test for HIV, hepatitis B surface antigen (HBsAg), and hepatitis C virus (HCV) antibody at the initial Screening Visit.
17. History of systemic active infectious diseases (eg, sepsis, tuberculosis) at the initial Screening Visit.
18. Those who have a history of malignant tumor or lymphoproliferative disease or have received an organ transplant within 5 years of initial Screening Visit.
19. Participants who have received systemic steroids, immunosuppressants, antiplatelet agents or anticoagulants within 1 week before application of this clinical trial drug.
20. History of abnormal wound healing such as keloids or hypertrophic scars.
21. History of significant drug abuse within 12 months prior to Screening or positive urine drug test at Screening.
22. Chronic kidney disease Stages 1 to 5.
18 Years
70 Years
ALL
No
Sponsors
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Primoris Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Joanneke Joanneke, Dr
Role: PRINCIPAL_INVESTIGATOR
The Concord Repatriation General Hospital
Locations
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The Concord Repatriation General Hospital
Sydney, New South Wales, Australia
Countries
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Central Contacts
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Other Identifiers
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PMS-101-A001
Identifier Type: -
Identifier Source: org_study_id
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