Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Plazomicin · 1 trial · 1 indication
Plasma PK parameter for plazomicin before and after IHD
Plasma PK parameter for plazomicin before and after IHD
Plasma PK parameter for plazomicin before and after IHD
Plasma PK parameter for plazomicin before and after IHD
Plasma PK parameter for plazomicin before and after IHD
Plasma PK parameter for plazomicin before and after IHD
Plasma PK parameter for plazomicin before and after IHD
Plasma PK parameter for plazomicin before and after IHD
| Arm | Type | Description |
|---|---|---|
| Plazomicin Injection | EXPERIMENTAL | plazomicin (30-minute IV infusion at 2.5 mg/kg) single dose given before IHD and single dose given after IHD |
| Name | Type | Description |
|---|---|---|
| Plazomicin Injection | DRUG | single dose of plazomicin |
Inclusion Criteria: * Male and female subjects between 18 and 75 years of age with a BMI ≥19 to ≤42 kg/m2 and weight of ≥40 kg * Pre-existing ESRD requiring in-center IHD for a minimum of 3 months on a schedule of three IHD sessions per week with the third weekly IHD session occurring at least 72 h...