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

NCT02757755 | Completed Phase 1

• 2 other identifiers: AB-SA01-01WRAIR-2285
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Cohort 10^8

EXPERIMENTAL

AB-SA01 (10\^8) and Placebo

Biological: AB-SA01 (10^8 PFU per phage); Biological: Placebo (for Cohort 10^8)

Cohort 10^9

EXPERIMENTAL

AB-SA01 (10\^9) and Placebo

Biological: AB-SA01 (10^9 PFU per phage); Biological: Placebo (for Cohort 10^9)

Interventions

AB-SA01 (10^8 PFU per phage) BIOLOGICAL

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.

Cohort 10^8

AB-SA01 (10^9 PFU per phage) BIOLOGICAL

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.

Cohort 10^9

Placebo (for Cohort 10^8) BIOLOGICAL

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.

Cohort 10^8

Placebo (for Cohort 10^9) BIOLOGICAL

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.

Cohort 10^9

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Armata Pharmaceuticals, Inc.: lead
• Walter Reed Army Institute of Research (WRAIR): collaborator

Study Sites (1)

Clinical Trials Center, WRAIR

Silver Spring, Maryland, 20910, United States

Location

Study Officials

• Jeffrey Livezey, MD

  Walter Reed Army Institute of Research (WRAIR)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2016
• First Posted: May 2, 2016
• Study Start: May 1, 2016
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: August 31, 2016

Record last verified: 2016-08

Locations

US (1)