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

NCT07379684 | Recruiting Phase 1 DMC FDA Drug

• 4 other identifiers: BETA-TS-001224842/Z/21/ZAgreement dated 02/28/2023Agreement Dated 01/30/2023
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 4

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. 1.Is Amicidin-β topical solution safe to test in larger clinical trials?
2. 2.Is Amicidin-β topical solution absorbed into the bloodstream from local wound application?
3. 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

Keywords

Surgical wound infection; Traumatic wound infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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.

  From Day 1 to Day 3

Study Arms (4)

SOC + Amicidin-β topical solution - 15 mL

EXPERIMENTAL

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; Drug: Standard of Care (SOC)

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

EXPERIMENTAL

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: Amicidin-β topical solution - 50 mL; Drug: Standard of Care (SOC)

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

EXPERIMENTAL

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: Amicidin-β topical solution - 50 mL; Drug: Standard of Care (SOC)

SOC

ACTIVE COMPARATOR

Patients will receive Standard of Care (SOC) only

Drug: Standard of Care (SOC)

Interventions

Amicidin-β topical solution - 15 mL DRUG

Amicidin-β topical solution for local administration - 15 mL

SOC + Amicidin-β topical solution - 15 mL

Amicidin-β topical solution - 50 mL DRUG

Amicidin-β topical solution for local administration - 50 mL

SOC + Amicidin-β topical solution - 50 mL - Scheme 1; SOC + Amicidin-β topical solution - 50 mL - Scheme 2

Standard of Care (SOC) DRUG

Per institutional Standard Of Care

SOC; SOC + Amicidin-β topical solution - 15 mL; SOC + Amicidin-β topical solution - 50 mL - Scheme 1; SOC + Amicidin-β topical solution - 50 mL - Scheme 2

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (4)

Lundquist Institute

Torrance, California, 90502, United States

RECRUITING

Snake River Research, PLLC

Idaho Falls, Idaho, 83404, United States

RECRUITING

LifeBridge Health

Baltimore, Maryland, 21215, United States

RECRUITING

The Ohio State University

Columbus, Ohio, 43210, United States

RECRUITING

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Daniel J Gowen-Huang, MBA

CONTACT

(323) 717-0302; dgowenhuang@macrobiologics.com

Michael P Bevilacqua, MD, PhD

CONTACT

(303) 881-5169; mpb@macrobiologics.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2026
• First Posted: January 30, 2026
• Study Start (Estimated): May 31, 2026
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 28, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)