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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06440239




Registration number
NCT06440239
Ethics application status
Date submitted
22/05/2024
Date registered
3/06/2024
Date last updated
5/07/2024

Titles & IDs
Public title
A Study to Evaluate the Safety, Tolerability and Efficacy in Patients With Burn(s)
Scientific title
A Phase 1/Phase 2a Study to Evaluate the Safety, Tolerability and Efficacy of PMS-101 Administration in Patients With Burn(s)
Secondary ID [1] 0 0
PMS-101-A001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Burns 0 0
Burn Degree Second 0 0
Condition category
Condition code
Injuries and Accidents 0 0 0 0
Burns

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - PMS-101
Other interventions - Standard treatment

Experimental: Investigational Product - PMS-101

Other: Control - Standard of care or treatment


Treatment: Drugs: PMS-101
PMS-101

Other interventions: Standard treatment
Standard treatment according to physicians
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Tolerability assessed by dose-limiting toxicity (Phase 1)
Timepoint [1] 0 0
Day7, Day9, Day11, Day14, Day17, Day21, Day28, Day56
Primary outcome [2] 0 0
Time to complete healing of wound site (Phase 2a)
Timepoint [2] 0 0
Day7, Day9, Day11, Day14, Day17, Day21, Day28, Day56, Day84

Eligibility
Key inclusion criteria
1. The combined TBSA of all burns is 10% or less.
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.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. 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.
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/01/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
28/02/2025
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
The Concord Repatriation General Hospital - Sydney
Recruitment postcode(s) [1] 0 0
2139 - Sydney

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Primoris Therapeutics
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT06440239
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Joanneke Joanneke, Dr
Address 0 0
The Concord Repatriation General Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Joanneke Maitz, Dr
Address 0 0
Country 0 0
Phone 0 0
+61408865606
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06440239