NCT03009734

Evaluation of ATx201 as a Topical Antibiotic Agent

A Prospective, Single Center, Randomized, Double-blind, Placebo Controlled Study in Two Phases to Evaluate the Safety and Efficacy of ATx201 as a Topical Antibiotic Agent

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 73 (actual)
• Sponsor: UNION therapeutics · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

AntibioTx is developping ATx201 as a topical product for treatment of skin infections, including infected atopic dermatitis.

Detailed description

Treatment of skin infections, including infected atopic dermatitis, is plagued by inactivity of or resistance towards the main topical antibiotics. Accordingly, the infections are either not effectively treated or harsher systemic antibiotics with side effects are needed. Infections in atopic dermatitis are predominantly caused by Staphylococcus aureus and various species of Streptococcus. ATx201 is a potent antibiotic against these and other organisms. ATx201 overcomes current resistance problems such as methicillin resistant Staphylococcus aureus (MRSA), vancomycin resistant enterococci (VRE) as well as resistance towards all topical antibiotics. ATx201 also exhibits an extraordinarily strong ability to delay the onset of de novo resistance compared to currently marketed antibiotics. The study is a combined Phase I/II study with 36 healthy volunteers and 40 patients. The primary objective is to demonstrate the safety and tolerability of new topical formulations of ATx201 in healthy volunteers, and in a population of patients with infected atopic dermatitis. Efficacy of ATx201 in eradicating S. aureus compared to vehicle after 4 and 7 days of treatment will be evaluated. In Phase I of the study, three formulations of ATx201 including the respective Placebos will be applied to healthy volunteers. One formulation will advance into Phase II, where patients will be treated with the respective formulation or Placebo.

Conditions

• Infection, Bacterial

Interventions

Type	Name	Description
DRUG	ATx201 dermal formulations 2%	Topical application of ATx201 dermal formulations 2%

Timeline

• Start date: 2016-12-01
• Primary completion: 2018-03-01
• Completion: 2018-03-01
• First posted: 2017-01-04
• Last updated: 2018-03-20

Locations

1 site across 1 country: Austria