Programs and studies

Clinical study

Ascending Dose Study of the Safety of AB-SA01 When Topically Applied to Intact Skin of Healthy Adults

StatusCompleted
TypeTrial
CountriesUnited States
Conditions studiedHealthy Volunteers
Study years2016–2016
Entry review2026-10-03

Participation

Check the study record or contact the study team for current recruitment and eligibility.

Study eligibility

Inclusion Criteria: 1. Male or female, 18 to 60 years of age, inclusive, at the time of the first treatment 2. Willing and able to sign the informed consent and adhere to the study schedule 3. Healthy subject as determined by the principal investigator or designee via medical history and clinical examination before enrollment in the study 4. Normal skin of the volar aspect of the forearms, as determined by the principal investigator or designee via examination 5. 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 6. 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. 7. 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: 1. Any past use of a bacteriophage product, or planned use from the time of screening and during the entire study period 2. 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 3. 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. 4. 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 5. 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) 6. Any other prohibited medication or treatment 7. Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history, physical examination, and screening serology (HIV, HbsAg, and anti-HCV) 8. History of congenital or hereditary immunodeficiency 9. History of any severe allergic reaction or hypersensitivity (anaphylaxis) 10. History of allergic reaction or irritant contact dermatitis due to wound dressings (eg, adhesive tapes, bandages, gauze) 11. History of allergic reaction to castor oil 12. Acute disease and/or fever at the time of study treatment 13. Acute or chronic, clinically significant pulmonary, cardiovascular, neurologic, hepatic, or renal functional abnormality as determined by medical history, physical examination, or laboratory screening tests 14. 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). 15. Administration of immunoglobulins and/or any blood products within the 3 months preceding the first study treatment or planned administration during the study period 16. 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. 17. Recent (within 12 months prior to screening) history of illicit drug abuse 18. Inability to comply with study requirements and restrictions 19. Any reason, considered by the principal investigator or designee, to preclude subject involvement in the study

Study description

This study will examine the safety of ascending doses of AB-SA01 when topically applied to intact skin of healthy adults.

Study registrations

ClinicalTrials.govNCT02757755
Recorded study locations (1)

Locations listed in the study record; this does not confirm current recruitment or treatment outside the study. A site label may be older than the overall study status.

Clinical Trials Center, WRAIR

Silver Spring, Maryland, United States

Recorded site status: Not separately listed. Study location source ↗

Sources and updates

Entry reviewed . This is the date of our source review, not a confirmation of availability today.

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Study ID
nct02757755