Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
514G3 plus standard antibiotic treatment · 1 trial · 1 indication
Dose limiting Toxicity are defined as any Grade 3 or greater AE which is probably or definitely related to 514G3 occurring during the FU period after dosing. This measure determines and assesses the maximum tolerated dose (MTD) through participants who experienced DLT at different dose levels.
A summary of SAEs and other non-serious AEs, regardless of causality
| Arm | Type | Description |
|---|---|---|
| Phase I | EXPERIMENTAL | A phase I of the trial is a dose escalation study intended to assess the possible toxicity and to determine the recommended phase 2 dose (RP2D) of the study drug (514G3). Randomized subjects were administered the study drug at 3 dose levels i.e. 2 mg/kg, 10 mg/kg, and 40 mg/kg or placebo. |
| Phase II | EXPERIMENTAL | A phase 2 of the trial is a dose expansion study designed to assess the preliminary efficacy. Eligible subjects are randomized (2:1) and received a single dose of 40 mg/kg study drug (514G3) with standard IV treatment versus placebo with standard IV treatment. |
| Name | Type | Description |
|---|---|---|
| 514G3 (2 mg/kg) plus standard IV antibiotic treatment | BIOLOGICAL | - |
| 514G3 (10 mg/kg) plus standard IV antibiotic treatment | BIOLOGICAL | - |
| 514G3 (40 mg/kg) plus standard IV antibiotic treatment | BIOLOGICAL | - |
| Placebo plus standard IV antibiotic treatment | OTHER | Sterile isotonic formulation buffered at pH 6.2 - 6.5 plus standard IV antibiotic treatment |
| 514G3 (40 mg/kg) plus standard IV antibiotic treatment: Phase II | BIOLOGICAL | A single dose of 514G3 plus standard IV antibiotic therapy |
| Placebo plus standard IV antibiotic treatment: Phase II | OTHER | A single dose of placebo plus standard IV antibiotic therapy |
Inclusion Criteria: 1. One or more blood cultures positive for staphylococcus aureus within 2 days of initiating treatment with 514G3. 2. Temperature ≥ 38.0°C 3. Age ≥18, male or female subjects. 4. Adequate renal function, defined by serum creatinine ≤ 2 times the upper limit of normal (ULN). 5. A...