Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06440239
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-05-22
Brief Title:
A Study to Evaluate the Safety Tolerability and Efficacy in Patients With Burns
Sponsor:
Primoris Therapeutics
Organization:
Primoris Therapeutics
Study Overview
Official Title:
A Phase 1Phase 2a Study to Evaluate the Safety Tolerability and Efficacy of PMS-101 Administration in Patients With Burns
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 2higher 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 1lower 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None