A Study to Evaluate the Safety, Tolerability and Efficacy in Patients With Burn(s)
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorPrimoris Therapeutics
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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 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.
Trial design
Treatments tested in this trial
- PMS-101
- Standard treatment
Treatment groups
40 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov