Safety of Single Intravenous Administration of S95010 in Human Healthy Volunteers

Servier

Status and phase: Completed; Phase 1

Conditions: Cardiovascular Diseases

Treatments: Drug: S 95010; Other: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03494712

CL1-95010-001

2017-004180-12 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 49 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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49 participants in 2 patient groups, including a placebo group

S 95010

Experimental group

Description:

Increasing single doses of S 95010 to 5 subjects.

Treatment:

Drug: S 95010

Placebo

Placebo Comparator group

Description:

Increasing single doses of Placebo to 2 subjects.

Treatment:

Other: Placebo