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. 2017 May 5;9(5):742–755. doi: 10.1080/19420862.2017.1324376

Table 4.

In vivo studies for anti-DLL4 IgG1 mAb.

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: Hepatic centrilobular to bridging sinusoidal dilation
1 mg/kg (iv) Decreased red blood cells (monitorable)
3 mg/kg (iv) Proliferative vascular neoplasms
10 mg/kg (iv) – Skin, lung, and heart lesions seen only in rats
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: Hepatic centrilobular to bridging sinusoidal dilation
0.2 mg/kg (iv) Decreased red blood cells (monitorable)
0.8 mg/kg (iv)
3 mg/kg (iv)
12 mg/kg (iv)