Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
RPX7009 · 3 trials · 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.
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.
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 |
|---|---|---|
| Single and multiple dose of RPX7009 | EXPERIMENTAL | Single and multiple dose of RPX7009 |
| Single and multiple dose of RPX2014 | EXPERIMENTAL | Single and multiple dose of RPX2014 |
| Normal Saline | PLACEBO_COMPARATOR | Single and multiple dose of normal saline |
| Combination RPX7009 and RPX2014 | EXPERIMENTAL | Single and Multiple dose of Combination RPX7009 and RPX2014 |
| Single dose IV of biapenem or RPX7009 | EXPERIMENTAL | Single dose IV infusion of biapenem or RPX7009 |
| Single dose of biapenem or RPX7009 | EXPERIMENTAL | Single IV dose of biapenem or RPX7009 (for those on active drug, this will be the drug not given in the first IV treatment) |
| Biapenem and RPX7009 in combination | EXPERIMENTAL | Single dose followed by a multiple dose of biapenem and RPX7009 in combination |
| Ascending Single and Multiple dose of RPX7009 | EXPERIMENTAL | Ascending Single and Multiple dose of RPX7009 |
| Name | Type | Description |
|---|---|---|
| RPX7009 | DRUG | Two (2) groups of 15 subjects (12 active and 3 placebo) are planned for evaluation in cohort 1. Cohorts 2-5, 14 subjects (11 active and 3 placebo) are planned for evaluation in each cohort. 14 subjects (12 active and 2 placebo) are planned for evaluation in cohort 6. |
| RPX2014 | DRUG | Two (2) groups of 15 subjects (12 active and 3 placebo) are planned for evaluation for cohort 1. Cohorts 2-5, 14 subjects (11 active and 3 placebo) are planned for evaluation in each cohort. 14 subjects (12 active and 2 placebo) are planned for evaluation in cohort 6. |
| Placebo | DRUG | Two (2) groups of 15 subjects (12 active and 3 placebo) are planned for evaluation for cohort 1. Cohorts 2-5, 14 subjects (11 active and 3 placebo) are planned for evaluation in each cohort. 14 subjects (12 active and 2 placebo) are planned for evaluation in cohort 6. |
| Combination RPX7009 and RPX2014 | DRUG | Two (2) groups of 15 subjects (12 active and 3 placebo) are planned for evaluation in cohort 1. Cohorts 2-5, 14 subjects (11 active and 3 placebo) are planned for evaluation in each cohort. 14 subjects (12 active and 2 placebo) are planned for evaluation in cohort 6. |
| Biapenem | DRUG | Up to three (3) cohorts of 10 healthy adult subjects (8 active, 2 placebo) |
| Normal saline | DRUG | Up to three (3) cohorts of 10 healthy adult subjects (8 active, 2 placebo) |
Inclusion Criteria: 1. Healthy adult males and females, 18 to 55 years of age (inclusive) at the time of screening. 2. Body mass index (BMI) ≥ 18.5 and ≤ 29.9 (kg/m2) and weight between 55.0 and 100.0 kg (inclusive). 3. Medically healthy with clinically insignificant screening results (e.g., labora...