Approximately 48 healthy volunteers participated in the study, with 16 recruited for each of three dose groups. In each dose group, 12 volunteers received a single dose of Bioral Amphotericin B and four received a placebo.
Amphotericin B plasma concentrations were measured over a period of 14 days. The study identified doses that were well-tolerated with no meaningful changes in laboratory safety values including those associated with renal function.
The preliminary pharmacokinetic evaluation also revealed that plasma concentrations were comparable to those seen in prior animal toxicology studies using the same formulation. In previous animal studies conducted by BioDelivery Sciences International (BDSI), doses used in toxicology studies have been shown to produce measurable tissue concentrations and efficacy against the fungal infections candidiasis and aspergillosis.
BDSI currently has collaborations for the development of Bioral amphotericin B with the National Institutes of Health (NIH), which has supported in part the preclinical program, and for clinical development in cutaneous leishmaniasis with Walter Reed Army Institute for Research.
David Blum, vice president of clinical research and medical affairs of BDSI, said: This study provides the important initial support for us to progress the clinical development of Bioral amphotericin B. We plan to conduct additional pharmacokinetic studies in healthy volunteers followed by Phase II studies in infected patients.