Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 developed by Armata Pharmaceuticals, Inc. (ticker ARMP). It is a bacteriophage-based therapy designed to act against Staphylococcus aureus, and it has been studied in healthy adult volunteers rather than in patients with an active infection. It remains in clinical development and is not an approved medicine.
AB-SA01 targets Staphylococcus aureus, a bacterium. Its target class is bacteria, so it is an antibacterial agent rather than a drug aimed at a human protein or receptor. The Phase 1 program evaluated topical application to intact skin in healthy adults to assess safety and tolerability of the product.
AB-SA01 is developed by Armata Pharmaceuticals, Inc., which trades under the ticker ARMP. The company sponsored the clinical work for the asset. AB-SA01 is also referred to as AB-SA01 (10^8 PFU per phage), a description that reflects the phage concentration used in the formulation.
AB-SA01 is in Phase 1 clinical development. It has not been approved by the FDA or any other regulator, and it remains an investigational product. The completed Phase 1 study enrolled 12 participants and was conducted in the United States.
AB-SA01 has been studied in one clinical trial, NCT02757755, titled "Ascending Dose Study of the Safety of AB-SA01 When Topically Applied to Intact Skin of Healthy Adults." That Phase 1 trial was completed, enrolled 12 participants, was randomized, double blind, and controlled, and included only healthy volunteers aged 18 years and older.
Yes. AB-SA01 (10^8 PFU per phage) is another way of naming AB-SA01, describing the phage concentration of 10^8 plaque-forming units per phage in the formulation. Both names refer to the same investigational Armata Pharmaceuticals product studied in the Phase 1 skin safety trial.