Safety of Single Intravenous Administration of S95010 in Human Healthy Volunteers

Safety, Tolerability and Pharmacokinetics of S 95010 After Single Escalating Intravenous Doses in Young Healthy Male Subjects. A Randomised, Doubleblind, Placebo-controlled, Monocentre, First-In-Human Study.

The purpose of the study is to assess, the safety and tolerability of single ascending doses of S 95010 and to assess the pharmacokinetics (PK) of S 95010.

Inclusion Criteria:

• Young healthy male subjects aged between 18 and 45 years (both inclusive)

Exclusion Criteria:

• Any acute or chronic illness or clinically relevant findings such as livers,kidney, spleen, cardiovascular disease, eye disease in the selection/ inclusion visit examinations
• Any abnormal laboratory result on blood and urine samples taken during screening, judged clinically relevant by the investigator
• History of liver dysfunction or total bilirubin or ALT or AST or ALP or γGT > ULN at selection
• History of renal dysfunction or GFR < 75mL/min/1.73 m2 (MDRD equation) at selection