Infection, Bacterial Clinical Trial
Official title:
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
AntibioTx is developping ATx201 as a topical product for treatment of skin infections, including infected atopic dermatitis.
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.
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