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

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

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Biological: AB-SA01 (10^8 PFU per phage); Biological: Placebo (for Cohort 10^8); Biological: AB-SA01 (10^9 PFU per phage); Biological: Placebo (for Cohort 10^9)

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: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Silver Spring, Maryland, United States, 20910
      • Clinical Trials Center, WRAIR

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	Occurrence, intensity, and relationship of adverse events (AEs) from first dose through the End of Study visit	From first dose through the End of Study visit (Day 14 ± 2 days)
Change from Baseline in Clinical Laboratory Tests	Clinical laboratory tests (hematology, chemistry, and urinalysis)	Day 0 (pre-dose), Day 3, and Day 14 ± 2 days
Skin Reaction Change from Baseline	skin reaction assessments	Days 0, 1, and 2 (pre- and post-dose), and on Day 3, Day 7 ± 1 day, and Day 14 ± 2 days

Collaborators and Investigators

• Sponsor: Armata Pharmaceuticals, Inc.
• Collaborators: Walter Reed Army Institute of Research (WRAIR)
• Investigators: Principal Investigator: Jeffrey Livezey, MD, Walter Reed Army Institute of Research (WRAIR)

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: April 27, 2016
• First Submitted That Met QC Criteria: April 28, 2016
• First Posted (Estimate): May 2, 2016

Study Record Updates

• Last Update Posted (Estimate): August 31, 2016
• Last Update Submitted That Met QC Criteria: August 29, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: AB-SA01-01; WRAIR-2285 (Other Identifier: Walter Reed Army Institute of Research)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided