NCT07379684

A Study of Amicidin-β Topical Solution for Patients With Surgical or Traumatic Wound Infections

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: Macro Biologics, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Surgical Wound Infection
• Traumatic Wound Infection

Interventions

Type	Name	Description
DRUG	Amicidin-β topical solution - 15 mL	Amicidin-β topical solution for local administration - 15 mL
DRUG	Amicidin-β topical solution - 50 mL	Amicidin-β topical solution for local administration - 50 mL
DRUG	Standard of Care (SOC)	Per institutional Standard Of Care

Timeline

• Start date: 2026-04-30
• Primary completion: 2027-02-28
• Completion: 2027-02-28
• First posted: 2026-01-30
• Last updated: 2026-04-09

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study