Exogenous viral target; repeat-dose studies omitted owing to immunogenicity in animals and lack of human tissue binding
“The lack of repeated dose toxicity studies (including reproductive toxicity) was justified by the company by the immunogenicity of the human compound in animals and the lack of binding of the compound to a range of tissues.”
No surrogate; the clinical antibody was tested in single-dose rat and cynomolgus monkey studies
“A single dose toxicity study of palivizumab administered to Sprague Dawley rats via intravenous injection including assessment of clinical signs, body weight changes, food consumption, ophthalmoscopy, haematology, clinical and anatomic pathology until 14 days post injection”