Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 drug being studied for use in healthy volunteers. It is being evaluated in a Phase 1 clinical trial to assess its safety when applied topically to intact skin. The drug is not yet approved and remains in clinical development.
AB-SA01 is being developed by Armata Pharmaceuticals, Inc., a company traded on the stock market under the ticker symbol ARMP. The company is conducting clinical research to evaluate the safety of this investigational drug.
AB-SA01 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The Phase 1 trial is designed to evaluate the safety of the drug when applied topically to intact skin.
AB-SA01 has one completed clinical trial, identified as NCT02757755. This was a Phase 1, ascending dose study that evaluated the safety of AB-SA01 when topically applied to intact skin of healthy adults. The trial enrolled 12 participants in the United States.
AB-SA01 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The completed trial, NCT02757755, was a safety study in healthy volunteers, and the drug has not yet progressed to later-stage trials or received regulatory approval.