Ascending Dose Study of the Safety of AB-SA01 When Topically Applied to Intact Skin of Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Change from Baseline in Clinical Laboratory Tests
研究概览
简要总结
This study will examine the safety of ascending doses of AB-SA01 when topically applied to intact skin of healthy adults.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Cohort 10^8
AB-SA01 (10^8) and Placebo
干预措施: AB-SA01 (10^8 PFU per phage) (Biological)
Cohort 10^8
AB-SA01 (10^8) and Placebo
干预措施: Placebo (for Cohort 10^8) (Biological)
Cohort 10^9
AB-SA01 (10^9) and Placebo
干预措施: AB-SA01 (10^9 PFU per phage) (Biological)
Cohort 10^9
AB-SA01 (10^9) and Placebo
干预措施: Placebo (for Cohort 10^9) (Biological)
结局指标
主要结局
Change from Baseline in Clinical Laboratory Tests
时间窗: Day 0 (pre-dose), Day 3, and Day 14 ± 2 days
Clinical laboratory tests (hematology, chemistry, and urinalysis)
Skin Reaction Change from Baseline
时间窗: Days 0, 1, and 2 (pre- and post-dose), and on Day 3, Day 7 ± 1 day, and Day 14 ± 2 days
skin reaction assessments
Adverse Events
时间窗: From first dose through the End of Study visit (Day 14 ± 2 days)
Occurrence, intensity, and relationship of adverse events (AEs) from first dose through the End of Study visit
次要结局
未报告次要终点