Table 5.
Species | Study | Dose/s | Group sex and size | Findings |
---|---|---|---|---|
Sprague Dawley rat | 8 week GLP toxicology | 0 mg/kg (iv) | 10M+10F/group and 5M+5F recovery/group and 6M+6F TK satellites/group | Liver findings: Decreased severity compared with IgG, minimal changes observed at low doses (up to 10 mg/kg) |
3 mg/kg (iv) | Acceptable hematology profile | |||
10 mg/kg (iv) | Proliferative vascular neoplasms not observed | |||
100 mg/kg (iv) | New findings: Vascular proliferative/degenerative changes in the heart and lung potentially related to pulmonary hypertension | |||
30 mg/kg (iv) | ||||
Cynomolgus monkey | 8 week GLP toxicology with 12 week recovery | 0 mg/kg (iv) | 3M+3F/group and 2M+2F recovery/group and 2M+2F for telemetry on the control and high dose group | Liver findings: Decreased severity compared with IgG |
5 mg/kg (iv) | Acceptable hematology profile | |||
15 mg/kg (iv) | New findings: Vascular proliferative/degenerative changes in the heart and lung potentially related to pulmonary hypertension | |||
50 mg/kg (iv) |