Safety of Single Intravenous Administration of S95010 in Human Healthy Volunteers

Study Overview
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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.

Official Title
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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.

Conditions
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Cardiovascular Diseases

Intervention / Treatment
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* Drug: S 95010
* Other: Placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: S 95010<br>Increasing single doses of S 95010 to 5 subjects. | Drug: S 95010<br>* Single administration of S 95010 in healthy volunteers<br>|
| Placebo Comparator: Placebo<br>Increasing single doses of Placebo to 2 subjects. | Other: Placebo<br>* Single administration of placebo in healthy volunteers<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety assessed by incidence of Adverse Events | Safety criterion | Through study completion, an average of 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The PK (pharmacokinetic) profile of S 95010 plasma concentration : Area under the plasma concentration-time curve (AUC) | Safety and pharmacokinetic criteria - S 95010 (active parent compound) and its metabolites (if applicable) concentration in serial plasma and urinary samples | During Hospitalization Period (Day 1, Day 2, Day 3, Day 4) and during ambulatory follow-up period (at Week 2, Week 4 and Week 12) | 
| The PK profile of S 95010 plasma concentration : Plasma half-life | Safety and pharmacokinetic criteria - S 95010 (active parent compound) and its metabolites (if applicable) concentration in serial plasma and urinary samples | During Hospitalization Period (Day 1, Day 2, Day 3, Day 4) and during ambulatory follow-up period (at Week 2, Week 4 and Week 12) | 
| The PK profile of S 95010 plasma concentration : Maximum plasma concentration (Cmax) | Safety and pharmacokinetic criteria - S 95010 (active parent compound) and its metabolites (if applicable) concentration in serial plasma and urinary samples | During Hospitalization Period (Day 1, Day 2, Day 3, Day 4) and during ambulatory follow-up period (at Week 2, Week 4 and Week 12) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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healthy volunteer, antimiR, single ascending dose