Recruiting
Phase 1

Amicidin-β

Sponsor:

Macro Biologics, Inc.

Code:

NCT07379684

Conditions

Surgical Wound Infection

Traumatic Wound Infection

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Amicidin-β topical solution - 15 mL

Amicidin-β topical solution - 50 mL

Standard of Care (SOC)

Study Details

Brief 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.

Conditions

Surgical Wound Infection

Traumatic Wound Infection

Study ID

NCT07379684

Start date

Sep 30, 2026

Status verified date

Jan, 2026

Completion date

Feb 28, 2027

Anticipated

Primary completion date

Feb 28, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 an interventional procedure, such as incision, drainage, irrigation, and/or debridement.
  • If female of childbearing potential, must have been practicing an acceptable method of birth control as judged by the Investigator for at least one month prior to enrollment.
  • Females of childbearing potential must agree that for the entire duration of the study (about 30 days), they will either practice true abstinence consistent with their preferred and usual lifestyle, or use double contraceptive methods.

Main Exclusion Criteria:

Patients with any of the following will be excluded:

  • Surgical or traumatic wound associated with surrounding cellulitis extending ≥10 cm from the wound edge
  • Confirmed necrotizing fasciitis or gangrenous ulcer
  • Multiple surgical or traumatic wound infections at different sites
  • Surgical or traumatic wound infection overlying bone fracture, with radiological evidence of non-union
  • Surgical or traumatic wound infection with open peritoneal cavity
  • Surgical or traumatic wound infection extending to an organ space
  • Surgical or traumatic wound infection extending to implanted surgical hardware or protesis. Note: surgical drains and packing are permitted
  • Surgical or traumatic wound infection involving head and neck
  • Surgical or traumatic wound infection involving burn injury
  • Suspected or confirmed osteomyelitis or septic arthritis
  • Surgical or traumatic wound infection known or suspected to be caused by fungal or mycobacterial organisms
  • Wound with diagnosis of neuropathic or diabetic foot ulcer or a previous diagnosis of moderate to severe chronic venous insufficiency of a lower extremity in patients with an infected surgical to traumatic wound of the lower extremity
  • Wound due to malignancy
  • Antibiotic therapy for an infection other than the surgical or traumatic wound infection
  • Patient requires supplemental O2 or mechanical ventilation
  • Pulse Oximetry (SpO2) reading of ≤ 92% on room air (confirmed by two additional readings ≤92% over 15 min). At geographic locations of high altitude, a lower SpO2 limit (e.g., ≤ 91%) may be used at Investigator's discretion

Study Design

Enrollment

44 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: SOC + Amicidin-β topical solution - 15 mL

In addition to Standard of Care (SOC), patients will receive Amicidin-β topical solution - 15 mL immediately prior to wound closure/dressing, with rinsing out with saline.

experimental: SOC + Amicidin-β topical solution - 50 mL - Scheme 1

In addition to Standard of Care (SOC), patients will be receive Amicidin-β topical solution - 50 mL immediately prior to wound closure/dressing, with rinsing out with saline

experimental: SOC + Amicidin-β topical solution - 50 mL - Scheme 2

In addition to Standard of Care (SOC), patients will be receive Amicidin-β topical solution - 50 mL immediately prior to wound closure/dressing, without rinsing out with saline

active comparator: SOC

Patients will receive Standard of Care (SOC) only

Interventions

Amicidin-β topical solution - 15 mL

Amicidin-β topical solution for local administration - 15 mL

Amicidin-β topical solution - 50 mL

Amicidin-β topical solution for local administration - 50 mL

Standard of Care (SOC)

Per institutional Standard Of Care

Primary outcome measure

  • Overall comparison of treatment emergent adverse events (TEAES) of combined SOC + Amicidin-β topical solution recipients to SOC only recipients across 3 cohorts. [ Time Frame: From Day 1 to Day 30 ]

Central Contacts and Locations

Central contacts

Daniel J Gowen-Huang, MBA

(323) 717-0302dgowenhuang@macrobiologics.com

Michael P Bevilacqua, MD, PhD

(303) 881-5169mpb@macrobiologics.com

Locations

Lundquist Institute

Recruiting

Torrance, California, United States, 90502

Snake River Research, PLLC

Recruiting

Idaho Falls, Idaho, United States, 83404

LifeBridge Health

Recruiting

Baltimore, Maryland, United States, 21215

Washington University in St. Louis

Recruiting

St Louis, Missouri, United States, 631110

The Ohio State University

Recruiting

Columbus, Ohio, United States, 43210

More Information

Sponsor

Macro Biologics, Inc.

Last update posted

Aug 17, 2026

Last verified

Jan, 2026

Keywords

  • Surgical wound infection
  • Traumatic wound infection

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Macro Biologics, Inc. on 2026-08-17.