NCT02757755

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Armata Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-05-01
• Primary completion: 2016-08-01
• Completion: 2016-08-01
• First posted: 2016-05-02
• Last updated: 2016-08-31

Locations

1 site across 1 country: United States