Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
J147 Emulsion · 1 trial · 1 indication
Continuous vital signs, 12-Lead ECG, and laboratory assessments will be summarized using descriptive statistics, which includes count, mean, median, standard deviation, min and max by treatment arm and visits. Incidence and severity of adverse events and serious adverse events will be summarized with count and percentages by treatment arm, overall and by System Organ Class and Preferred Term. Deaths will be listed.
| Arm | Type | Description |
|---|---|---|
| Low Dose J147 | EXPERIMENTAL | J147 Emulsion for Injection, 1.6 mg/kg |
| Low Dose Placebo | PLACEBO_COMPARATOR | - |
| High Dose J147 | EXPERIMENTAL | J147 Emulsion for Injection, 2.5 mg/kg |
| High Dose Placebo | PLACEBO_COMPARATOR | - |
| Target Dose J147 | EXPERIMENTAL | J147 Emulsion for Injection |
| Target Dose Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| J147 Emulsion for Injection | DRUG | J147 Emulsion for Injection, 20 mg/mL for IV administration, low dose 1.6 mg/kg, high dose 2.5 mg/kg, single IV injection |
| Placebo | OTHER | Vehicle without J147, single IV injection |
Inclusion Criteria: * Signed informed consent obtained from the patient or legally authorized representative. * A new focal disabling neurologic deficit consistent with acute cerebral ischemia. * Baseline NIHSS ≥5 and ≤25 points obtained prior to randomization with a disabling neurological deficit ...