BurnsPhase 1/2NCT06440239
A Study to Evaluate the Safety, Tolerability and Efficacy in Patients With Burn(s)
A Phase 1/2 study testing PMS-101 and Standard treatment in people with Burns and Burn Degree Second, run by Primoris Therapeutics at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Burns, Burn Degree Second
- What is being tested?
- PMS-101 and Standard treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteAustralia
- Study dates
- 1 Jan 2025to 28 Feb 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
- History of type 1 diabetes or active type 2 diabetes.
- History of severe endocrine disorders such as Cushing's disease, hypogonadism, and growth hormone deficiency.
- 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.
- Uncontrolled psychiatric disease including major depressive disorder, bipolar, anxiety disorder, or eating disorders such as bulimia.
- 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.
- Positive test for HIV, hepatitis B surface antigen (HBsAg), and hepatitis C virus (HCV) antibody at the initial Screening Visit.
- History of systemic active infectious diseases (eg, sepsis, tuberculosis) at the initial Screening Visit.
- Those who have a history of malignant tumor or lymphoproliferative disease or have received an organ transplant within 5 years of initial Screening Visit.
- Participants who have received systemic steroids, immunosuppressants, antiplatelet agents or anticoagulants within 1 week before application of this clinical trial drug.
- History of abnormal wound healing such as keloids or hypertrophic scars.
- History of significant drug abuse within 12 months prior to Screening or positive urine drug test at Screening.
- Chronic kidney disease Stages 1 to 5.
Trial locations and contacts
1 site in 1 country.
Australia1 site
The Concord Repatriation General Hospital
Sydney, New South Wales, 2139
About this study
Official title: A Phase 1/Phase 2a Study to Evaluate the Safety, Tolerability and Efficacy of PMS-101 Administration in Patients With Burn(s)
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.
Read the detailed description
Phase 1 is a single arm, open label, non-randomised study designed to assess the safety, tolerability and efficacy of 2 planned dose levels of PMS-101. The decision to continue dosing in Cohort 2(higher level dose) at the planned dosage regimen will be made by the Safety Review Committee (SRC) following the review of the safety and tolerability data of the participants in Cohort 1(lower level dose). The tolerability assessment of all the enrolled participants will be completed to determine the RP2D.
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
- Burns, Burn Degree Second
- Being tested
- PMS-101, Standard treatment
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PMS-101Drug
PMS-101
Standard treatmentOther
Standard treatment according to physicians
| Study group | Role | What they receive |
|---|---|---|
| Investigational Product | Experimental | PMS-101 Receives: Drug: PMS-101 |
| Control | Other | Standard of care or treatment Receives: Other: Standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerability assessed by dose-limiting toxicity (Phase 1)
Measured: Day7, Day9, Day11, Day14, Day17, Day21, Day28, Day56
Time to complete healing of wound site (Phase 2a)
Measured: Day7, Day9, Day11, Day14, Day17, Day21, Day28, Day56, Day84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2024
- Study start1 Jan 2025 (estimated)
- Primary completion28 Feb 2025 (estimated)
- Study completion28 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Primoris Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joanneke Joanneke, Dr, Principal investigator, The Concord Repatriation General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06440239
- Sponsor's protocol ID
- PMS-101-A001
- Status last verified
- Jul 2024
- First submitted
- 22 May 2024
- Last updated
- 5 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/Phase 2a Study to Evaluate the Safety, Tolerability and Efficacy of PMS-101 Administration in Patients With Burn(s)
- ClinicalTrials.gov ID
- NCT06440239
- Acronym / sponsor ID
- PMS-101-A001
- Conditions
- Burns, Burn Degree Second
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Primoris TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 28 Feb 2025 (estimated)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 3 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Phase 1 is a single arm, open label, non-randomised study designed to assess the safety, tolerability and efficacy of 2 planned dose levels of PMS-101. The decision to continue dosing in Cohort 2(higher level dose) at the planned dosage regimen will be made by the Safety Review Committee (SRC) following the review of the safety and tolerability data of the participants in Cohort 1(lower level dose). The tolerability assessment of all the enrolled participants will be completed to determine the RP2D.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Investigational Product | Experimental | Drug: PMS-101PMS-101 |
| Control | Other | Other: Standard treatmentStandard of care or treatment |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (27 listed)
- 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:
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PMS-101PMS-101 | Drug | Investigational Product |
| Standard treatmentStandard treatment according to physicians | Other | Control |
Primary outcome
Tolerability assessed by dose-limiting toxicity (Phase 1)
Time frame: Day7, Day9, Day11, Day14, Day17, Day21, Day28, Day56
Time to complete healing of wound site (Phase 2a)
Time frame: Day7, Day9, Day11, Day14, Day17, Day21, Day28, Day56, Day84
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joanneke Joanneke, Dr principal investigator
The Concord Repatriation General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing PMS-101 and Standard treatment in people with Burns and Burn Degree Second, run by Primoris Therapeutics at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joanneke Maitz, Dr (+61408865606, jo.maitz@skingineering.com.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tolerability assessed by dose-limiting toxicity (Phase 1) (time frame: Day7, Day9, Day11, Day14, Day17, Day21, Day28, Day56). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2024.