NCT03494712

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Institut de Recherches Internationales Servier · Academic / Other
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	S 95010	Single administration of S 95010 in healthy volunteers
OTHER	Placebo	Single administration of placebo in healthy volunteers

Timeline

• Start date: 2018-02-21
• Primary completion: 2019-04-10
• Completion: 2019-04-10
• First posted: 2018-04-11
• Last updated: 2020-02-17

Locations

1 site across 1 country: Belgium

Regulatory

• FDA-regulated drug study