Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Bisphosphocin Nu-3 · 1 trial · 1 indication
The severity of each adverse event, as judged by the investigator, was graded according to the CTCAE v4.02. Treatment-emergent adverse events are defined as adverse events with onset times after dosing, or pre-existing adverse events that worsened during the study.
The microbiological response to bisphosphocin Nu-3 based on aerobic and anaerobic culture and sensitivity was determined by measuring the reduction of pathogenic bacteria following Nu-3 treatment. Each laboratory used their own standards to decide whether the cultures were normal or abnormal.
| Arm | Type | Description |
|---|---|---|
| Bisphosphocin Nu-3 | EXPERIMENTAL | Dosage Form: Topical Antimicrobial, Dosage: 1mg/mL, 10 mg/mL, 20 mg/mL, 50 mg/mL, 100 mg/mL Frequency: QD for day 1, 2x daily for 7 days, Duration: 8 days |
| Placebo | PLACEBO_COMPARATOR | Dosage Form: Diluent, Frequency: QD for day 1, 2x daily for 7 days, Duration: 8 days |
| Name | Type | Description |
|---|---|---|
| Bisphosphocin Nu-3 | DRUG | - |
| Placebo | DRUG | - |
Inclusion Criteria: 1. Men and women between the ages of 18 and 85. 2. Voluntary written consent, given before performance of any clinical investigation-related procedure not part of standard medical care, and with the understanding that consent may be withdrawn at any time without prejudice to fut...
Bisphosphocin Nu-3 is an investigational small molecule being developed for the treatment of diabetic foot infections. It is applied topically to infected diabetic ulcers in patients with type I or II diabetes mellitus. The drug is currently in Phase 1 clinical development.
Bisphosphocin Nu-3 is being developed by Lakewood-Amedex Biotherapeutics Inc., a biopharmaceutical company. The company is conducting clinical trials to evaluate the drug's safety and efficacy in treating diabetic foot infections.
Bisphosphocin Nu-3 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 1 clinical trial has been completed to assess its use in patients with diabetic foot infections.
Bisphosphocin Nu-3 has been studied in a completed Phase 1 clinical trial with the identifier NCT02737722. The trial evaluated topically applied Bisphosphocin Nu-3 on infected diabetic ulcers in subjects with type I or II diabetes mellitus. The study enrolled 31 participants in the United States.
Bisphosphocin Nu-3 is the drug name used in clinical development. It is a small molecule being investigated for diabetic foot infections. The drug is not approved and remains in clinical trials.