Study | Test Article | Route | Dose | Dose Number | n | NAUC_168 h | Npeak | NT_max |
---|---|---|---|---|---|---|---|---|
μg/kg; MIU/kg | h·ng/ml | ng/ml | h | |||||
1 | IFN β-1a | IM | 5; 1 | 1 | 5 | 1970 (689) | 21.0 (6.8) | 27.2 (4.38) |
1 | IFN β-1a | SC | 5; 1 | 1 | 5 | 1680 (327) | 21.4 (3.71) | 25.6 (3.58) |
1 | PEG-IFN β-1a | IM | 10.8; 1 | 1 | 5 | 2050 (266) | 21.8 (3.29) | 24.0 (0) |
1 | PEG-IFN β-1a | SC | 10.8; 1 | 1 | 5 | 2050 (441) | 20.2 (3.76) | 28.8 (4.38) |
2 | PEG-IFN β-1a | SC | 2; 0.22 | 1 | 4 | 1090 (539) | 10.4 (4.1) | 36.0 (13.9) |
2 | PEG-IFN β-1a | SC | 10; 1.1 | 1 | 4 | 1560 (462) | 14.8 (4.7) | 24.0 (0.0) |
2 | PEG-IFN β-1a | SC | 100; 11 | 1 | 4 | 2640 (573) | 22.8 (5.4) | 42.0 (12.0) |
2 | PEG-IFN β-1a | IM | 100; 11 | 1 | 3a | 3190 (625) | 27.0 (3.4) | 32.0 (13.9) |
3 | Control | IM, SC | 0 | 1 | 12 | N.A. | 5.02 (2.60)b | 24 (0)b |
3 | Control | IM, SC | 0 | 3 | 12 | N.A. | 3.66 (3.06)b | 24 (0)b |
3 | Control | IM, SC | 0 | 5 | 12 | N.A. | 3.39 (2.64)b | 24 (0)b |
3 | PEG-IFN β-1a | SC | 2; 0.22 | 1 | 8 | N.A. | 9.27 (6.01)b | 24 (0)b |
3 | PEG-IFN β-1a | SC | 2; 0.22 | 3 | 8 | N.A. | 8.28 (7.80)b | 24 (0)b |
3 | PEG-IFN β-1a | SC | 2; 0.22 | 5 | 8 | N.A. | 5.28 (5.55)b | 24 (0)b |
3 | PEG-IFN β-1a | SC | 10; 1.1 | 1 | 8 | N.A. | 13.4 (2.88)b | 24 (0)b |
3 | PEG-IFN β-1a | SC | 10; 1.1 | 3 | 8 | N.A. | 9.27 (3.38)b | 24 (0)b |
3 | PEG-IFN β-1a | SC | 10; 1.1 | 5 | 8 | N.A. | 5.85 (5.69)b | 24 (0)b |
3 | PEG-IFN β-1a | SC | 100; 11 | 1 | 12 | N.A. | 26.9 (5.95)b | 24 (0)b |
3 | PEG-IFN β-1a | SC | 100; 11 | 3 | 12 | N.A. | 16.4 (6.90)b | 24 (0)b |
3 | PEG-IFN β-1a | SC | 100; 11 | 5 | 12 | N.A. | 7.32 (3.89)b | 24 (0)b |
3 | PEG-IFN β-1a | IM | 100; 11 | 1 | 12 | N.A. | 23.2 (5.12)b | 24 (0)b |
3 | PEG-IFN β-1a | IM | 100; 11 | 3 | 12 | N.A. | 16.7 (6.23)b | 24 (0)b |
3 | PEG-IFN β-1a | IM | 100; 11 | 5 | 12 | N.A. | 4.81 (3.43)b | 24 (0)b |
IM, intramuscular; SC, subcutaneous; N.A., not available.
a Data from one monkey were excluded because of unusually high predose and postdose peak concentration (25.8 and 100 ng/ml, respectively).
b One postdose sample was collected at 24 h as an approximation of Npeak after administration of doses 1, 3, and 5; hence, NAUC_168 h was not available and NT_MAX was 24 h for all animals in study 3.