Safety of Single Intravenous Administration of S95010 in Human Healthy Volunteers

NCT03494712 | Completed Phase 1 FDA Drug

• 2 other identifiers: CL1-95010-0012017-004180-12
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases

Keywords

healthy volunteer; antimiR; single ascending dose

Outcome Measures

Primary Outcomes (1)

• Safety assessed by incidence of Adverse Events

  Safety criterion

  Through study completion, an average of 12 weeks

Secondary Outcomes (3)

• 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)

• 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)

• 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)

Study Arms (2)

S 95010

EXPERIMENTAL

Increasing single doses of S 95010 to 5 subjects.

Drug: S 95010

Placebo

PLACEBO COMPARATOR

Increasing single doses of Placebo to 2 subjects.

Other: Placebo

Interventions

S 95010 DRUG

Single administration of S 95010 in healthy volunteers

S 95010

Placebo OTHER

Single administration of placebo in healthy volunteers

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Young healthy male subjects aged between 18 and 45 years (both inclusive)

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut de Recherches Internationales Servier: lead
• ADIR, a Servier Group company: collaborator

Study Sites (1)

SGS Clinical Pharmacology Unit - Stuivenberg Hospital

Antwerp, B-2060, Belgium

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2018
• First Posted: April 11, 2018
• Study Start: February 21, 2018
• Primary Completion: April 10, 2019
• Study Completion: April 10, 2019
• Last Updated: February 17, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: After Marketing Authorisation in EEA or US if the study is used for the approval.
• 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.

Locations

BE (1)