The CZ48 toxicology program consisted of exploratory (nonGLP) dose range-finding studies in the mouse and dog and definitive (GLP) toxicity and toxicokinetic studies in both species. Pivotal toxicology studies conducted with CZ48 employed the intended clinical route and schedule of administration. Additionally, two studies (nonGLP) were conducted in mice to assess the general tolerability of chronic high-dose CZ48 administration.