Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02757755 | Ascending Dose Study of the Safety of AB-SA01 When Topically Applied to Intact Skin of Healthy Adults | PHASE1 | COMPLETED | 12 | — | — | May 1, 2016 | Aug 1, 2016 | Aug 31, 2016 | 1 | United States |
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...