Approval Probability
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Also known as AB-SA01 (10^8 PFU per phage)
AB-SA01 · 1 trial · 1 indication
Occurrence, intensity, and relationship of adverse events (AEs) from first dose through the End of Study visit
Clinical laboratory tests (hematology, chemistry, and urinalysis)
skin reaction assessments
| Arm | Type | Description |
|---|---|---|
| Cohort 10^8 | EXPERIMENTAL | AB-SA01 (10\^8) and Placebo |
| Cohort 10^9 | EXPERIMENTAL | AB-SA01 (10\^9) and Placebo |
| Name | Type | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
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 e...
AB-SA01 is an investigational antibacterial product being developed by Armata Pharmaceuticals, Inc. (ticker ARMP). It is a biologic therapy designed to act against Staphylococcus aureus bacteria. AB-SA01 has been studied in a Phase 1 clinical trial involving healthy adult volunteers, and it is not an approved medicine.
AB-SA01 targets Staphylococcus aureus, a type of bacteria. Its target class is bacteria, which distinguishes it from drugs that act on human proteins or other molecular targets. By acting on Staphylococcus aureus directly, AB-SA01 is being developed as an antibacterial agent rather than as a treatment aimed at a human host target.
AB-SA01 is being developed by Armata Pharmaceuticals, Inc., which trades under the ticker symbol ARMP. Armata is the company responsible for advancing the program. The candidate has completed one Phase 1 clinical trial to date, and no other developer is named for this asset.
AB-SA01 is in Phase 1 development. One Phase 1 trial has been completed, and no active trials are currently listed for the program. Because it remains in clinical development, AB-SA01 is investigational and has not been approved by the FDA for any use.
AB-SA01 has been studied in one completed Phase 1 trial, NCT02757755, titled "Ascending Dose Study of the Safety of AB-SA01 When Topically Applied to Intact Skin of Healthy Adults." The trial enrolled 12 participants in the United States, used a randomized, double-blind, controlled design, and included healthy volunteers aged 18 years and older.
Yes, AB-SA01 (10^8 PFU per phage) is an alternative way of referring to AB-SA01. The parenthetical describes the dose strength of 10^8 plaque-forming units per phage. Both names refer to the same investigational product developed by Armata Pharmaceuticals, Inc. under the ticker ARMP.