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

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.

Study Overview

• Status: Recruiting
• Conditions: Surgical Wound Infection; Traumatic Wound Infection
• Intervention / Treatment: Drug: Amicidin-β topical solution - 15 mL; Drug: Standard of Care (SOC); Drug: Amicidin-β topical solution - 50 mL

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.

• Study Type: Interventional
• Enrollment (Estimated): 44
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Daniel J Gowen-Huang, MBA; Phone Number: (323) 717-0302; Email: dgowenhuang@macrobiologics.com
• Study Contact Backup: Name: Michael P Bevilacqua, MD, PhD; Phone Number: (303) 881-5169; Email: mpb@macrobiologics.com

Study Locations

• United States
  • California
    • Torrance, California, United States, 90502
      • Recruiting
      • Lundquist Institute
  • Idaho
    • Idaho Falls, Idaho, United States, 83404
      • Recruiting
      • Snake River Research, PLLC
  • Maryland
    • Baltimore, Maryland, United States, 21215
      • Recruiting
      • LifeBridge Health
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • The Ohio State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Amicidin-β topical solution - 15 mL; Amicidin-β topical solution for local administration - 15 mL; Drug: Standard of Care (SOC); Per institutional Standard Of Care
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	Drug: Standard of Care (SOC); Per institutional Standard Of Care; Drug: Amicidin-β topical solution - 50 mL; Amicidin-β topical solution for local administration - 50 mL
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	Drug: Standard of Care (SOC); Per institutional Standard Of Care; Drug: Amicidin-β topical solution - 50 mL; Amicidin-β topical solution for local administration - 50 mL
Active Comparator: SOC; Patients will receive Standard of Care (SOC) only	Drug: Standard of Care (SOC); Per institutional Standard Of Care

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with Treatment Emergent Adverse Events (TEAEs) by severity according to the study protocol.		From Day 1 to Day 30
Measurement of systemic absorption of Amicidin-β recipients.	Systemic absorption will be assessed by single molecule array (Simoa) immunoassay measurements of patient plasma.	From Day 1 to Day 3

Collaborators and Investigators

• Sponsor: Macro Biologics, Inc.
• Collaborators: Biomedical Advanced Research and Development Authority; Global Antimicrobial Resistance Innovation Fund-(GAMRIF); Novo Nordisk Foundation (NNF23SA0088536); US NIH Grant/Contract Award Number: HHS/BARDA OTA No. 75A50122C00028; Wellcome Trust 224842/Z/21/Z; Germany's Federal Ministry of Education and Research (BMBF) Agreement Dated 1/30/23; UK Secretary of State for Health and Social Care ("DHSC"), Agreement dated 02/28/2023

Study record dates

Study Major Dates

• Study Start (Estimated): May 31, 2026
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 28, 2027

Study Registration Dates

• First Submitted: January 6, 2026
• First Submitted That Met QC Criteria: January 23, 2026
• First Posted (Actual): January 30, 2026

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Surgical wound infection; Traumatic wound infection
• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Infections; Wound Infection; Pathological Conditions, Signs and Symptoms; Surgical Wound Infection; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: BETA-TS-001; 224842/Z/21/Z (Other Grant/Funding Number: Wellcome Trust); Agreement dated 02/28/2023 (Other Grant/Funding Number: UK Secretary of State for Health and Social Care ("DHSC")); Agreement Dated 01/30/2023 (Other Grant/Funding Number: Germany's Federal Ministry of Education and Research (BMBF))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No