TABLE 3.
Serum levels of anti-rSAL-1 antibodies determined at the 50-day poststudy visit in each participant
Participant identification code | Treatment | Dose (mg/kg) | Antibody levela (μg/ml) |
---|---|---|---|
R101 | Activeb | 0.1 | NQ |
R102 | Active | 0.1 | NA |
R103 | Placebo | 0.1 | NQ |
R104 | Active | 0.1 | NQ |
R201 | Active | 0.3 | NQ |
R202 | Active | 0.3 | NQ |
R203 | Active | 0.3 | 2.833 |
R204 | Placebo | 0.3 | NQ |
R205 | Active | 0.3 | NQ |
R206 | Placebo | 0.3 | NQ |
R207 | Active | 0.3 | NQ |
R208 | Active | 0.3 | NQ |
R301 | Placebo | 1 | NQ |
R302 | Active | 1 | NQ |
R303 | Active | 1 | NQ |
R304 | Active | 1 | NQ |
R305 | Placebo | 1 | NQ |
R306 | Active | 1 | 1.916 |
R307 | Active | 1 | 3.562 |
R308 | Active | 1 | 2.035 |
R401 | Active | 3 | 12.055 |
R402 | Active | 3 | NQ |
R403 | Placebo | 3 | NQ |
R404 | Active | 3 | NQ |
R405 | Active | 3 | 5.326 |
R406 | Active | 3 | NA |
R407 | Placebo | 3 | NQ |
R408 | Active | 3 | 3.759 |
R501 | Active | 10 | NQ |
R502 | Active | 10 | 9.990 |
R503 | Active | 10 | NQ |
R504 | Placebo | 10 | NQ |
R505 | Active | 10 | 4.684 |
R506 | Active | 10 | NQ |
R507 | Placebo | 10 | NQ |
R508 | Active | 10 | 5.068 |
NQ, not quantifiable as the value was less than the LLOQ (1.563 μg/ml); NA, not assayed, as a sample was unavailable.
Active, active pharmaceutical ingredient.