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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):
Armata Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE April 27, 2016
First Posted Date  ICMJE May 2, 2016
Last Update Posted Date August 31, 2016
Study Start Date  ICMJE May 2016
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 9, 2016)
  • 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
  • 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)
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: April 28, 2016)
  • Adverse Events [ Time Frame: From first dose through the End of Study visit (Day 14 ± 2 days) ]
    Occurrence, intensity, and relationship of AEs from first dose through the End of Study visit
  • 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)
  • 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
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ascending Dose Study of the Safety of AB-SA01 When Topically Applied to Intact Skin of Healthy Adults
Official Title  ICMJE Ascending Dose Study of the Safety of AB-SA01 When Topically Applied to Intact Skin of Healthy Adults
Brief Summary This study will examine the safety of ascending doses of AB-SA01 when topically applied to intact skin of healthy adults.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Masking: Double (Participant, Investigator)
Condition  ICMJE Healthy Volunteers
Intervention  ICMJE
  • 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: 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 10^8)
    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.
  • 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.
Study Arms  ICMJE
  • Experimental: Cohort 10^8
    AB-SA01 (10^8) and Placebo
    Interventions:
    • Biological: AB-SA01 (10^8 PFU per phage)
    • Biological: Placebo (for Cohort 10^8)
  • Experimental: Cohort 10^9
    AB-SA01 (10^9) and Placebo
    Interventions:
    • Biological: AB-SA01 (10^9 PFU per phage)
    • Biological: Placebo (for Cohort 10^9)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 28, 2016)
12
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2016
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02757755
Other Study ID Numbers  ICMJE AB-SA01-01
WRAIR-2285 ( Other Identifier: Walter Reed Army Institute of Research )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Armata Pharmaceuticals, Inc.
Study Sponsor  ICMJE Armata Pharmaceuticals, Inc.
Collaborators  ICMJE Walter Reed Army Institute of Research (WRAIR)
Investigators  ICMJE
Principal Investigator: Jeffrey Livezey, MD Walter Reed Army Institute of Research (WRAIR)
PRS Account Armata Pharmaceuticals, Inc.
Verification Date August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP