A Phase 1 Study to Assess Safety and Tolerability of Amicidin-β Topical Solution in Adult Patients Undergoing Interventional Management of a Surgical or Traumatic Wound Infection
Macro Biologics, Inc.
Summary
The goal of this Phase 1 clinical trial is to learn about the safety profile of Amicidin-β topical solution applied directly into infected surgical or traumatic wounds during a surgical procedure. The main questions it aims to answer are: 1. Is Amicidin-β topical solution safe to test in larger clinical trials? 2. Is Amicidin-β topical solution absorbed into the bloodstream from local wound application? 3. Is Amicidin-β topical solution easy for the surgeon to use? Participants will receive either standard of care alone, or standard of care with intrawound Amicidin-β topical solution for the management of their wound infection. Researchers will compare these two groups (standard of care alone to standard of care with Amicidin-β topical solution) to see if there are any study drug-related adverse effects.
Description
This is a Standard of Care (SOC)- controlled study of approximately 44 patients divided into three sequential cohorts of 8, 12, and 24 patients. Within each sequential cohort, patients will be randomized to SOC only or to SOC plus Amicidin-β topical solution in a 1:3 ratio.
Eligibility
- Age range
- 18–79 years
- Sex
- All
- Healthy volunteers
- No
Main Inclusion Criteria: * Body Mass Index between 18.5 kg/square meter and 39.9kg/square meter * Surgical or traumatic wound determined by the Investigator to be infected within 90 days of surgery or trauma, with longest dimension between 3 and 15 cm. The diagnosis should include one or more of the following signs or symptoms: * Purulent drainage * Erythema * Surrounding induration * Fever or localized heat surrounding the wound * Reported localized pain or localized tenderness on examination * Infected surgical or traumatic wound that is determined by the Investigator to required…
Interventions
- DrugAmicidin-β topical solution - 15 mL
Amicidin-β topical solution for local administration - 15 mL
- DrugAmicidin-β topical solution - 50 mL
Amicidin-β topical solution for local administration - 50 mL
- DrugStandard of Care (SOC)
Per institutional Standard Of Care
Locations (4)
- Lundquist InstituteTorrance, California
- Snake River Research, PLLCIdaho Falls, Idaho
- LifeBridge HealthBaltimore, Maryland
- The Ohio State UniversityColumbus, Ohio