Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as 5% Nu-3 gel, 5% Nu-3, 10% Nu-3 gel, 10% Nu-3, Antimicrobial agent
Nu-3 · 2 trials · 2 indications
The rate reduction in CFUs by ≥ 2 logs per pathogen, which is identified as typical and highly suspicious for being the cause of the infection compared to baseline.
Number of AEs overall and those assessed by the investigators as possibly, probably, and definitely related to the study drug as well as the number of SAEs per patient and cohort.
Number of AEs overall and those assessed by the investigators as possibly, probably, and definitely related to the study drug; number of SAEs per patient and cohort
The rate of reduction in CFUs by \>=2 logs per pathogen identified as typical and highly suspicious for being the cause of the infection, in each treatment group compared to placebo group at Day 7 compared to Day 0, and Day 14 compared to Day 0.
| Arm | Type | Description |
|---|---|---|
| 2.5mg dose | EXPERIMENTAL | Twice daily application for 14 days |
| 5mg dose | EXPERIMENTAL | Twice daily application for 14 days |
| 10mg dose | EXPERIMENTAL | Twice daily application for 14 days |
| 5% Nu-3 gel once daily | EXPERIMENTAL | The 5% Nu-3 gel is applied once per day and placebo is applied once per day. |
| 5% Nu-3 gel twice daily | EXPERIMENTAL | The 5% Nu-3 gel is applied twice per day. |
| 10% Nu-3 gel once daily | EXPERIMENTAL | The 10% Nu-3 gel is applied once per day and placebo is applied once per day. |
| 10% Nu-3 gel twice daily | EXPERIMENTAL | The 10% Nu-3 gel is applied twice per day. |
| Placebo | PLACEBO_COMPARATOR | The placebo is applied twice per day. |
| Name | Type | Description |
|---|---|---|
| Antimicrobial agent | DRUG | Topical antimicrobial gel application twice a day for 2 weeks |
| 5% Nu-3 gel | DRUG | The gel is called Nu-3 which is either applied once per day or twice per day to the infected ulcer. |
| 10% Nu-3 gel | DRUG | The gel is called Nu-3 which is either applied once per day or twice per day to the infected ulcer. |
| Placebo | DRUG | Placebo gel is either applied once per day or twice per day to the infected ulcer. |
Inclusion Criteria: 1. Male and female subjects ≥18 years of age. 2. Voluntary written informed consent, including information about the provisions of the Health Insurance Portability and accountability act (HIPAA) as applicable. 3. Non-hospitalized ambulatory subjects diagnosed with diabetes melli...