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

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ClinicalTrials.gov Identifier: NCT02757755
Recruitment Status : Completed
First Posted : May 2, 2016
Last Update Posted : August 31, 2016
Sponsor:
Collaborator:
Walter Reed Army Institute of Research (WRAIR)
Information provided by (Responsible Party):
AmpliPhi Biosciences Corporation

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

Condition or disease Intervention/treatment Phase
Healthy Volunteers Biological: AB-SA01 (10^8 PFU per phage) Biological: AB-SA01 (10^9 PFU per phage) Biological: Placebo (for Cohort 10^8) Biological: Placebo (for Cohort 10^9) Phase 1

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Masking: Double (Participant, Investigator)
Official Title: Ascending Dose Study of the Safety of AB-SA01 When Topically Applied to Intact Skin of Healthy Adults
Study Start Date : May 2016
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Arm Intervention/treatment
Experimental: Cohort 10^8
AB-SA01 (10^8) and Placebo
Biological: AB-SA01 (10^8 PFU per phage)
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.

Biological: Placebo (for Cohort 10^8)
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.

Experimental: Cohort 10^9
AB-SA01 (10^9) and Placebo
Biological: AB-SA01 (10^9 PFU per phage)
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.

Biological: Placebo (for Cohort 10^9)
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.




Primary Outcome Measures :
  1. Adverse Events [ Time Frame: 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

  2. Change from Baseline in Clinical Laboratory Tests [ Time Frame: Day 0 (pre-dose), Day 3, and Day 14 ± 2 days ]
    Clinical laboratory tests (hematology, chemistry, and urinalysis)

  3. Skin Reaction Change from Baseline [ Time Frame: 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



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02757755


Locations
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United States, Maryland
Clinical Trials Center, WRAIR
Silver Spring, Maryland, United States, 20910
Sponsors and Collaborators
AmpliPhi Biosciences Corporation
Walter Reed Army Institute of Research (WRAIR)
Investigators
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Principal Investigator: Jeffrey Livezey, MD Walter Reed Army Institute of Research (WRAIR)

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Responsible Party: AmpliPhi Biosciences Corporation
ClinicalTrials.gov Identifier: NCT02757755     History of Changes
Other Study ID Numbers: AB-SA01-01
WRAIR-2285 ( Other Identifier: Walter Reed Army Institute of Research )
First Posted: May 2, 2016    Key Record Dates
Last Update Posted: August 31, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided