TABLE 5.
BRII-196 and BRII-198 pharmacokinetic parameters following a single intravenous infusion administration to the healthy adult participants.
| Antibody | Dose (mg) | Number of subject | Cmax (μg/ml) | Tmax (hour) | t1/2 (day) | CL (ml/day) | Vss (L) | AUClast (day× μg/mL) | AUCinf (day× μg/mL) |
|---|---|---|---|---|---|---|---|---|---|
| BRII-196 | 750 | 3 | 268 (19.9) | 4.6 | 48.6 (4.57) | 76.8 (11.2) | 4.86 (0.563) | 8,240 (764) | 8,950 (1,040) |
| 1500 | 6 | 598 (77.1) | 5.4 | 46.0 (8.11) | 72.3 (10.0) | 4.50 (0.567) | 19,300 (2,430) | 21,100 (2,900) | |
| 3,000 | 3 | 1300 (91.7) | 6.6 | 44.7 (6.76) | 72.0 (3.97) | 4.37 (0.298) | 38,900 (2,510) | 41,700 (2,200) | |
| BRII-198 | 750 | 3 | 244 (35.5) | 4.7 | 76.0 (8.99) | 59.4 (5.54) | 6.19 (0.746) | 10,400 (911) | 12,800 (1,240) |
| 1500 | 6 | 509 (107) | 5.4 | 72.3 (8.46) | 57.0 (9.46) | 5.78 (0.983) | 20,900 (2,950) | 26,900 (4,720) | |
| 3,000 | 3 | 1020 (149) | 6.8 | 83.2 (37.7) | 53.8 (8.82) | 6.08 (2.19) | 42,800 (9,680) | 56,700 (8,710) |
Abbreviations: SD; standard deviation; Cmax, observed maximum serum concentration; Tmax, time to reach observed maximum serum concentration; t1/2, terminal half-life; CL, systemic clearance; Vss, volume of distribution at steady state; AUClast, area under the concentration–time curve from time zero to the last measurable concentration; AUCinf, area under the concentration–time curve from time zero to infinity. All parameters are reported with mean and standard deviation in three significant figures except Tmax that is reported with median values.