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

A

Armata Pharmaceuticals

Status and phase

Completed
Phase 1

Conditions

Healthy Volunteers

Treatments

Biological: Placebo (for Cohort 10^8)
Biological: AB-SA01 (10^9 PFU per phage)
Biological: AB-SA01 (10^8 PFU per phage)
Biological: Placebo (for Cohort 10^9)

Study type

Interventional

Funder types

Industry
Other U.S. Federal agency

Identifiers

NCT02757755
WRAIR-2285 (Other Identifier)
AB-SA01-01

Details and patient eligibility

About

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

Full 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.

Enrollment

12 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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.
  • Recent (within 12 months prior to screening) history of illicit drug abuse
  • Inability to comply with study requirements and restrictions
  • Any reason, considered by the principal investigator or designee, to preclude subject involvement in the study

Trial design

12 participants in 2 patient groups

Cohort 10^8
Experimental group
Description:
AB-SA01 (10^8) and Placebo
Treatment:
Biological: AB-SA01 (10^8 PFU per phage)
Biological: Placebo (for Cohort 10^8)
Cohort 10^9
Experimental group
Description:
AB-SA01 (10^9) and Placebo
Treatment:
Biological: Placebo (for Cohort 10^9)
Biological: AB-SA01 (10^9 PFU per phage)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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