Affinium Pharmaceuticals, Ltd., Announces Results of AFN-1252 Multiple Ascending Dose Phase I Clinical Trial
Affinium Pharmaceuticals announced the results of a new multiple ascending dose Phase I study of its novel, selective-spectrum, anti-staphylococcal agent, AFN-1252 in a novel oral formulation.
The study examined the tolerability, safety and pharmacokinetics of immediate release tablets of AFN-1252. Cohorts of healthy volunteers were dosed 200mg, 300mg, and 400 mg of AFN-1252 once daily for 10 days.
The pharmacokinetic results indicate that doses of either 300 mg, and 400mg, once daily or 200 mg twice daily, met or exceeded exposures necessary for the treatment of serious staphylococcal infections. Most importantly, and as in all previous Phase 1 trials, AFN-1252 showed a very favorable safety profile for all doses studied with no treatment-related trends in clinical laboratory results including biochemistry and hematology, vital sign measurements, 12 lead ECG results, or physical examination findings. Adverse events reported in the study were limited to mild headache and mild nausea.
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