Non-Clinical Toxicology and safety assessment of a small molecule

al and safety pharmacology profile of the test item following intravenous infusion and to generate the nonclinical safety data required to support a first-in-human clinical trial and subsequent clinical development. The program shall be conducted in accordance with applicable regulatory requirements

and guidelines and shall generate data and documentation suitable for regulatory submissions in the European Union and the United States. Particular attention shall be given to the assessment of renal safety, including the characterization