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A Study to Evaluate the Safety, Tolerability and Efficacy in Patients With Burn(s)

ConditionsBurnsBurn Degree Second
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • PMS-101

    Drug

    PMS-101

  • Standard treatment

    Other intervention

    Standard treatment according to physicians

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Investigational ProductExperimental treatment 1 intervention
Group B: ControlOther 1 intervention

Trial outcomes

Primary outcomes

1

Tolerability assessed by dose-limiting toxicity (Phase 1)

Time frame
Day7, Day9, Day11, Day14, Day17, Day21, Day28, Day56
2

Time to complete healing of wound site (Phase 2a)

Time frame
Day7, Day9, Day11, Day14, Day17, Day21, Day28, Day56, Day84

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Primoris Therapeutics

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: