Ascending Dose Study of the Safety 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.

Inclusion criteria

• Male or female, 18 to 60 years of age, inclusive, at the time of the first treatment
• Willing and able to sign the informed consent and adhere to the study schedule
• Healthy subject as determined by the principal investigator or designee via medical history and clinical examination before enrollment in the study
• Normal skin of the volar aspect of the forearms, as determined by the principal investigator or designee via examination
• If female, the subject is not pregnant or breastfeeding and has a negative urine pregnancy test at screening, and prior to receiving the first study treatment
• If female of childbearing potential, the subject agrees to use adequate contraception from screening, throughout the study period, and for 30 days after completion of treatment.
• If male, subjects with female partners of childbearing potential must agree to use adequate contraception from screening, throughout the study period, and for 30 days after completion of treatment

Exclusion criteria

• Any past use of a bacteriophage product, or planned use from the time of screening and during the entire study period
• Planned participation in another clinical trial and/or use of any product that is investigational, drug, biologic or device, within 30 days preceding screening and during the entire study period
• Skin lesions, chronic skin conditions, scars or tattoo placement, as established by skin examination before enrollment in the study that would interfere with study treatment.
• Chronic administration (defined as more than 14 days total in the past 6 months) of immunosuppressant or other immune-modifying drugs within 6 months prior to the first study treatment
• Chronic administration of topical steroids to the volar aspect of the forearms (defined as more than 14 days total in the 6 months prior to the first study treatment)
• Any other prohibited medication or treatment
• Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history, physical examination, and screening serology (HIV, HbsAg, and anti-HCV)
• History of congenital or hereditary immunodeficiency
• History of any severe allergic reaction or hypersensitivity (anaphylaxis)
• History of allergic reaction or irritant contact dermatitis due to wound dressings (eg, adhesive tapes, bandages, gauze)
• History of allergic reaction to castor oil
• Acute disease and/or fever at the time of study treatment
• Acute or chronic, clinically significant pulmonary, cardiovascular, neurologic, hepatic, or renal functional abnormality as determined by medical history, physical examination, or laboratory screening tests
• Screening lab results with any Grade 2 or higher abnormality or clinically significant Grade 1 abnormality, as determined by the Common Terminology Criteria for Adverse Events (CTCAE).
• Administration of immunoglobulins and/or any blood products within the 3 months preceding the first study treatment or planned administration during the study period
• Recent (within 12 months prior to screening) history of chronic alcohol abuse, defined as a history of ethanol consumption on average > 40 g/day for women and 60 g/day for men for at least 12 months prior to Baseline.
• Recent (within 12 months prior to screening) history of illicit drug abuse
• Inability to comply with study requirements and restrictions
• Any reason, considered by the principal investigator or designee, to preclude subject involvement in the study