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A Study to Evaluate the Safety, Tolerability and Efficacy 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.
Study details:
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2025-01-01
Primary completion: 2025-02-28
Study completion finish: 2025-02-28
Study type
TREATMENT
Phase
PHASE1
PHASE2
Trial ID
NCT06440239
Intervention or treatment
DRUG: PMS-101
OTHER: Standard treatment
Conditions
- • Burns
- • Burn Degree Second
Find a site
Closest Location:
The Concord Repatriation General Hospital
Research sites nearby
Select from list below to view details:
The Concord Repatriation General Hospital
Sydney, New South Wales, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Investigational Product
| DRUG: PMS-101
|
OTHER: Control
| OTHER: Standard treatment
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Tolerability assessed by dose-limiting toxicity (Phase 1) | Not Specified | Day7, Day9, Day11, Day14, Day17, Day21, Day28, Day56 |
Time to complete healing of wound site (Phase 2a) | Not Specified | Day7, Day9, Day11, Day14, Day17, Day21, Day28, Day56, Day84 |
Secondary outcome
Frequently Asked Questions
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