Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
RPX2003 · 1 trial · 2 indications
Number of patients with adverse events; assessed by patient reporting, collection of vital signs, ECGs and absolute values and changes over time of hematology, chemistry and urinalysis.
| Arm | Type | Description |
|---|---|---|
| RPX2003 (Biapenem) | EXPERIMENTAL | Single and multiple dose of RPX2003 (Biapenem). |
| Normal Saline | PLACEBO_COMPARATOR | Single and multiple doses of normal saline. |
| Name | Type | Description |
|---|---|---|
| RPX2003 (Biapenem) | DRUG | Six (6) cohorts of 3 active or 8 subjects of 6 active are planned for evaluation. Single dose followed by multiple dose, three times a day. |
| Placebo | DRUG | Six (6) cohorts of 1 placebo or 8 subjects of 2 placebo are planned for evaluation. Single dose followed by multiple dose, three times a day. |
Inclusion Criteria: * Healthy adult males and/or females, 18 to 55 years of age * Body mass index (BMI) ≥ 18.5 and ≤ 29.9 (kg/m2) and weight between 55.0 and 100.0 kg (inclusive). * Medically healthy with clinically insignificant screening results * Non-tobacco/nicotine-containing product users for...