Table 1.
Summary of safety study of ERY974 in cynomolgus monkeys.
| Group | Animals (n) | Autopsy (day) | Dose (μg/kg/dose) | Average maximum IL-6 level (pg/mL)a | Clinical signs/histopathological findings |
|---|---|---|---|---|---|
| 1 (Control) | 3 (M) + 3 (F) | 8 | 0 | 48 | No finding |
| 2 (Low) | 3 (M) + 3 (F) | 22 | 0.1 | 32 | No finding (NOAEL) |
| 3 (Middle) | 3 (M) + 3 (F) | 22 | 1 | 231 | Red skin, increased body temperature, increased fibrinogen and triglyceride, decreased albumin in blood, |
| 4 (High) | 3 (M) + 3 (F) | 22 | 10 | 2505 | Red skin on head and/or complete body, hyperthermia, decreased body weight, low-to-no food consumption, hunched posture, decreased reactivity, decreased lymphocytes in the thymusb, increased infiltration of mononuclear cells and/or granulocytes in multiple tissues, No evidence of damages in tissues (liver, kidney, or gastrointestinal) |
| 5 (High) | 3 (M) + 3 (F) | 8 | 10 |
The symptoms, level of cytokines in the blood, clinical pathological and histopathological findings in animals after administration of ERY974 are summarized. The level of IL-6 has been previously described8.
a8 h after administration.
bObserved on both day 8 and 22 autopsy samples.
M male, F female, NOAEL no observed adverse effect level.