Safety of Single Intravenous Administration of S95010 in Human Healthy Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-21

Study Completion Date

2019-04-10

Brief Summary

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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.

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Detailed Description

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Conditions

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Cardiovascular Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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S 95010

Increasing single doses of S 95010 to 5 subjects.

Group Type EXPERIMENTAL

S 95010

Intervention Type DRUG

Single administration of S 95010 in healthy volunteers

Placebo

Increasing single doses of Placebo to 2 subjects.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Single administration of placebo in healthy volunteers

Interventions

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S 95010

Single administration of S 95010 in healthy volunteers

Intervention Type DRUG

Placebo

Single administration of placebo in healthy volunteers

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes