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.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03494712

Enrollment

Registered

2018-04-11

Start date

2018-02-21

Completion date

2019-04-10

Last updated

2020-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases

Keywords

healthy volunteer, antimiR, single ascending dose

Brief 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.

Interventions

DRUGS 95010

Single administration of S 95010 in healthy volunteers

OTHERPlacebo

Single administration of placebo in healthy volunteers

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Safety assessed by incidence of Adverse Events	Through study completion, an average of 12 weeks	Safety criterion

Secondary

Measure	Time frame	Description
The PK (pharmacokinetic) profile of S 95010 plasma concentration : Area under the plasma concentration-time curve (AUC)	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)	Safety and pharmacokinetic criteria - S 95010 (active parent compound) and its metabolites (if applicable) concentration in serial plasma and urinary samples
The PK profile of S 95010 plasma concentration : Plasma half-life	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)	Safety and pharmacokinetic criteria - S 95010 (active parent compound) and its metabolites (if applicable) concentration in serial plasma and urinary samples
The PK profile of S 95010 plasma concentration : Maximum plasma concentration (Cmax)	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)	Safety and pharmacokinetic criteria - S 95010 (active parent compound) and its metabolites (if applicable) concentration in serial plasma and urinary samples

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026