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drugset / Trial / NCT07379684

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

NCT07379684 ↗

Phase 1 Recruiting 44 enrolled Macro Biologics, Inc. Biomedical Advanced Research and Development Authority · collabGermany's Federal Ministry of Education and Research (BMBF) Agreement Dated 1/30/23 · collabGlobal Antimicrobial Resistance Innovation Fund-(GAMRIF) · collabNovo Nordisk Foundation (NNF23SA0088536) · collabUK Secretary of State for Health and Social Care ("DHSC"), Agreement dated 02/28/2023 · collabUS NIH Grant/Contract Award Number: HHS/BARDA OTA No. 75A50122C00028 · collabWellcome Trust 224842/Z/21/Z · collab
RandomizedSequentialOpen-labelTreatment

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.

Timeline

Start
2026-05-31
Primary completion
2027-02-28
Completion
2027-02-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Amicidin-β Unknown 15 ml Topical
Subject Amicidin-β Unknown 50 ml Topical

Indications

No indication recorded.