Amicidin-β for Wound Infections

Recruiting at 3 trial locations

Overseen By Michael P Bevilacqua, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Macro Biologics, Inc.

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

44 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

Inclusion Criteria

I have hard areas around my tumor.

I have pus coming from a wound.

I have skin redness.

What Are the Treatments Tested in This Trial?

Interventions

• Amicidin-β Topical Solution

How Is the Trial Designed?

Group I: SOC + Amicidin-β topical solution - 50 mL - Scheme 2 Experimental Treatment 2 Interventions

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

Group II: SOC + Amicidin-β topical solution - 50 mL - Scheme 1 Experimental Treatment 2 Interventions

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

Group III: SOC + Amicidin-β topical solution - 15 mL Experimental Treatment 2 Interventions

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.

Group IV: SOC Active Control 1 Intervention

Patients will receive Standard of Care (SOC) only

Who Is Running the Clinical Trial?

Macro Biologics, Inc.

Lead Sponsor

Biomedical Advanced Research and Development Authority

Collaborator

Trials

108

Recruited

574,000+

Novo Nordisk Foundation (NNF23SA0088536)

Collaborator

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

Collaborator

Global Antimicrobial Resistance Innovation Fund-(GAMRIF)

Collaborator

Trials

1

Recruited

160+

Wellcome Trust 224842/Z/21/Z

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