Date: 2016-08-03
Type of information: Completion of patient enrollment
phase: 1
Announcement: completion of patient enrollment
Company: AmpliPhi BioSciences (USA - VA)
Product: AB-SA01 (phage cocktail targeting Staphylococcus aureus)
Action
mechanism: bacteriophage.
Disease: Staphylococcus aureus infections
Therapeutic area: Infectious diseases
Country: USA
Trial
details: This study will examine the safety of ascending doses of AB-SA01 when topically applied to intact skin of healthy adults. (NCT02757755)
Latest
news: * On August 3, 2016, AmpliPhi Biosciences announced it has completed enrollment of its Phase 1 clinical trial to evaluate the safety of AB-SA01, its proprietary phage cocktail targeting Staphylococcus aureus infections. The double-blinded, placebo-controlled study began on May 24, 2016 and AmpliPhi expects to report topline results by the end of the third quarter of 2016. AmpliPhi Biosciences also expects to have complete study reports for its Phase 1 AB-SA01 trial l in patients with chronic rhinosinusitis later this year. * On May 24, 2016, AmpliPhi Biosciences announced it has dosed the first patient in its Phase 1 clinical trial to evaluate the safety of AB-SA01, AmpliPhi’s proprietary phage cocktail targeting Staphylococcus aureus (S. aureus) infections, administered topically to the intact skin of healthy adults. The trial is being conducted under a Collaborative Research and Development Agreement with the U.S. Army and at the Walter Reed Army Institute of Research Clinical Trials Center in Silver Spring, Maryland. The double-blind, ascending dose study is designed to evaluate the safety of AB-SA01 administered topically to the skin of up to six healthy adult volunteers between the ages of 18 and 60 years in each of two dose cohorts. Participants in the low- and high-dose cohorts will receive either 1 x 108 or 1 x 109 PFU/mL of AB-SA01, respectively, administered topically to the forearm with an occlusive bandage. Placebo will be administered to the opposite forearm, allowing each participant to serve as his or her own control. Participants will receive AB-SA01 and placebo daily for three consecutive days and will be followed for 10-14 days after the final treatment.
