This study will examine the safety of ascending doses of AB-SA01 when topically applied to intact skin of healthy adults.
AB-SA01 consists of three bacteriophages (viruses) that target Staphylococcus aureus bacteria. The safety of AB-SA01 will be assessed when topically administered once daily to the volar aspect of the forearm at a dose of 10\^8 plaque forming units (PFU) per phage for 3 consecutive days, and then at a dose of 10\^9 plaque forming units (PFU) per phage for 3 consecutive days. Both AB-SA01 and placebo will be administered to each subject to provide his/her own control for evaluation of skin reactions. The right or left placement of the placebo will be randomized and double-blinded.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
DOUBLE
Enrollment
12
Gauze pads will be saturated with AB-SA01 and then applied to each subject's volar forearm and covered with occlusive dressing once daily for 3 consecutive days. Placement of the gauze to each subject's right or left volar forearm will be randomized and double-blinded.
Gauze pads will be saturated with AB-SA01 and then applied to each subject's volar forearm and covered with occlusive dressing once daily for 3 consecutive days. Placement of the gauze to each subject's right or left volar forearm will be randomized and double-blinded.
Gauze pads will be saturated with Placebo and then applied to each subject's volar forearm and covered with occlusive dressing once daily for 3 consecutive days. Placement of the gauze to each subject's right or left volar forearm will be randomized and double-blinded.
Clinical Trials Center, WRAIR
Silver Spring, Maryland, United States
Adverse Events
Occurrence, intensity, and relationship of adverse events (AEs) from first dose through the End of Study visit
Time frame: From first dose through the End of Study visit (Day 14 ± 2 days)
Change from Baseline in Clinical Laboratory Tests
Clinical laboratory tests (hematology, chemistry, and urinalysis)
Time frame: Day 0 (pre-dose), Day 3, and Day 14 ± 2 days
Skin Reaction Change from Baseline
skin reaction assessments
Time frame: Days 0, 1, and 2 (pre- and post-dose), and on Day 3, Day 7 ± 1 day, and Day 14 ± 2 days
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Gauze pads will be saturated with Placebo and then applied to each subject's volar forearm and covered with occlusive dressing once daily for 3 consecutive days. Placement of the gauze to each subject's right or left volar forearm will be randomized and double-blinded.