Ciraparantag serum and BAP urine PK parameters from the phase 1 clinical trial, during period 1
| PK parameter, median (range) . | Ciraparantag dose, mg . | ||||||
|---|---|---|---|---|---|---|---|
| 5 . | 15 . | 25 . | 50 . | 100 . | 200 . | 300 . | |
| Ciraparantag serum | |||||||
| Tmax, h | 0.08 (0.07-0.13) | 0.08 (0.07-0.10) | 0.10 (0.07-0.10) | 0.09 (0.08-0.12) | 0.15 (0.13-0.17) | 0.14 (0.13-0.17) | 0.15 (0.13-0.17) |
| Cmax, ng/mL | 173 (85-249) | 634 (447-800) | 861 (702-1060) | 861 (702-1060) | 3860 (3250-4920) | 7755 (6280-10900) | 10570 (9660-12200) |
| t1/2, h | NA | 0.20 (0.16-0.33) | 0.19 (0.16-0.29) | 0.24 (0.17-0.36) | 0.24 (0.20-0.31) | 0.33 (0.24-0.39) | 0.32 (0.24-0.42) |
| CL, L/h | NA | 90.5 (71.6-133.7) | 116.0 (67.9-126.5) | 77.8 (65.3-104.3) | 76.1 (58.1-92.2) | 65.7 (49.4-90.4) | 79.9 (63.4-100.8) |
| V, L | NA | 25.4 (23.0-36.9) | 31.0 (28.2-34.9) | 26.6 (20.7-40.3) | 26.1 (22.9-36.1) | 30.4 (22.7-48.2) | 34.6 (29.4-47.7) |
| BAP urine | |||||||
| Ae0-24h, μg* | 5.26 (0.00-21.59) | 41.20 (0.00-77.50) | 76.04 (0.00-138.60) | 621.21 (249.76-1021.60) | 2527.32 (130.73-27919.18) | 40764.38 (4960.56-65748.24) | 43654.29 (12544.68-91064.80) |
| Fm0-24h, %† | 0.11 (0.00-0.43) | 0.27 (0.00-0.52) | 0.30 (0.00-0.55) | 1.24 (0.50-2.04) | 1.24 (0.50-2.04) | 20.38 (2.48-32.87) | 14.55 (4.18-30.35) |
| CLr, L/h | NA | NA | 1.16 (0.00-2.30) | 3.88 (1.16-7.26) | 5.73 (0.37-48.52) | 29.72 (4.55-74.70) | 23.38 (8.44-48.92) |
| PK parameter, median (range) . | Ciraparantag dose, mg . | ||||||
|---|---|---|---|---|---|---|---|
| 5 . | 15 . | 25 . | 50 . | 100 . | 200 . | 300 . | |
| Ciraparantag serum | |||||||
| Tmax, h | 0.08 (0.07-0.13) | 0.08 (0.07-0.10) | 0.10 (0.07-0.10) | 0.09 (0.08-0.12) | 0.15 (0.13-0.17) | 0.14 (0.13-0.17) | 0.15 (0.13-0.17) |
| Cmax, ng/mL | 173 (85-249) | 634 (447-800) | 861 (702-1060) | 861 (702-1060) | 3860 (3250-4920) | 7755 (6280-10900) | 10570 (9660-12200) |
| t1/2, h | NA | 0.20 (0.16-0.33) | 0.19 (0.16-0.29) | 0.24 (0.17-0.36) | 0.24 (0.20-0.31) | 0.33 (0.24-0.39) | 0.32 (0.24-0.42) |
| CL, L/h | NA | 90.5 (71.6-133.7) | 116.0 (67.9-126.5) | 77.8 (65.3-104.3) | 76.1 (58.1-92.2) | 65.7 (49.4-90.4) | 79.9 (63.4-100.8) |
| V, L | NA | 25.4 (23.0-36.9) | 31.0 (28.2-34.9) | 26.6 (20.7-40.3) | 26.1 (22.9-36.1) | 30.4 (22.7-48.2) | 34.6 (29.4-47.7) |
| BAP urine | |||||||
| Ae0-24h, μg* | 5.26 (0.00-21.59) | 41.20 (0.00-77.50) | 76.04 (0.00-138.60) | 621.21 (249.76-1021.60) | 2527.32 (130.73-27919.18) | 40764.38 (4960.56-65748.24) | 43654.29 (12544.68-91064.80) |
| Fm0-24h, %† | 0.11 (0.00-0.43) | 0.27 (0.00-0.52) | 0.30 (0.00-0.55) | 1.24 (0.50-2.04) | 1.24 (0.50-2.04) | 20.38 (2.48-32.87) | 14.55 (4.18-30.35) |
| CLr, L/h | NA | NA | 1.16 (0.00-2.30) | 3.88 (1.16-7.26) | 5.73 (0.37-48.52) | 29.72 (4.55-74.70) | 23.38 (8.44-48.92) |