NCT06440239

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

A Phase 1/Phase 2a Study to Evaluate the Safety, Tolerability and Efficacy of PMS-101 Administration in Patients With Burn(s)

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Primoris Therapeutics · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DRUG	PMS-101	PMS-101
OTHER	Standard treatment	Standard treatment according to physicians

Timeline

• Start date: 2025-01-01
• Primary completion: 2025-02-28
• Completion: 2025-02-28
• First posted: 2024-06-03
• Last updated: 2024-07-05

Locations

1 site across 1 country: Australia