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

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

Interventions

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

Sponsors & Collaborators

• Biomedical Advanced Research and Development Authority

  collaborator FED

• Novo Nordisk Foundation (NNF23SA0088536)

  collaborator UNKNOWN

• Global Antimicrobial Resistance Innovation Fund-(GAMRIF)

  collaborator UNKNOWN

• US NIH Grant/Contract Award Number: HHS/BARDA OTA No. 75A50122C00028

  collaborator UNKNOWN

• Wellcome Trust 224842/Z/21/Z

  collaborator UNKNOWN

• Germany's Federal Ministry of Education and Research (BMBF) Agreement Dated 1/30/23

  collaborator UNKNOWN

• UK Secretary of State for Health and Social Care ("DHSC"), Agreement dated 02/28/2023

  collaborator UNKNOWN

• Macro Biologics, Inc.

  lead INDUSTRY

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Max Age

79 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-05-31

Primary Completion

2027-02-28

Completion

2027-02-28

FDA Drug

Yes

Countries

• United States

Study Locations