Safety of Single Intravenous Administration of S95010 in Human Healthy Volunteers

• Status: Completed
• Trial end date: 2019-04-10
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Institut de Recherches Internationales Servier
• Collaborators: ADIR Association; ADIR, a Servier Group company

Criteria

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