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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02757755
• Other study ID #: AB-SA01-01
• Secondary ID: WRAIR-2285
• Status: Completed
• Phase: Phase 1
• First received: April 27, 2016
• Last updated: August 29, 2016
• Start date: May 2016
• Est. completion date: August 2016

Study information

• Verified date: August 2016
• Source: AmpliPhi Biosciences Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Clinical Trials Center, WRAIR	Silver Spring	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
AmpliPhi Biosciences Corporation	Walter Reed Army Institute of Research (WRAIR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Primary	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	No
Primary	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	No