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.

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases
• Intervention / Treatment: Drug: S 95010; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Antwerpen, Belgium, B-2060
    • SGS Clinical Pharmacology Unit - Stuivenberg Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: S 95010; Increasing single doses of S 95010 to 5 subjects.	Drug: S 95010; Single administration of S 95010 in healthy volunteers
PLACEBO_COMPARATOR: Placebo; Increasing single doses of Placebo to 2 subjects.	Other: Placebo; Single administration of placebo in healthy volunteers

What is the study measuring?

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)

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

• Results Summary

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 21, 2018
• Primary Completion (ACTUAL): April 10, 2019
• Study Completion (ACTUAL): April 10, 2019

Study Registration Dates

• First Submitted: February 16, 2018
• First Submitted That Met QC Criteria: April 4, 2018
• First Posted (ACTUAL): April 11, 2018

Study Record Updates

• Last Update Posted (ACTUAL): February 17, 2020
• Last Update Submitted That Met QC Criteria: February 13, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: healthy volunteer; single ascending dose; antimiR
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: CL1-95010-001; 2017-004180-12 (EUDRACT_NUMBER)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Researchers can ask for a study protocol, patient-level and/or study-level clinical trial data including clinical study reports (CSRs).

They can ask all interventional clinical studies:

• submitted for new medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).
• Where Servier or an affiliate are the Marketing Authorization Holders (MAH). The date of the first Marketing Authorization of the new medicine (or the new indication) in one of the EEA Member States will be considered within this scope.

• IPD Sharing Time Frame: After Marketing Authorisation in EEA or US if the study is used for the approval.
• IPD Sharing Access Criteria: Researchers should register on Servier Data Portal and fill in the research proposal form. This form in four parts should be fully documented. The Research Proposal Form will not be reviewed until all mandatory fields are completed.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Study Data/Documents

1. Individual Participant Data Set
2. Study Protocol
3. Statistical Analysis Plan
4. Informed Consent Form
5. Clinical Study Report
6. study-level clinical trial data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes