Safety of Single Intravenous Administration of S95010 in Human Healthy Volunteers
NCT03494712 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 49
Last updated 2020-02-17
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
Interventions
- DRUG
-
S 95010
Single administration of S 95010 in healthy volunteers
- OTHER
-
Placebo
Single administration of placebo in healthy volunteers
Sponsors & Collaborators
-
ADIR, a Servier Group company
collaborator INDUSTRY -
Institut de Recherches Internationales Servier
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 45 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2018-02-21
- Primary Completion
- 2019-04-10
- Completion
- 2019-04-10
- FDA Drug
- Yes
Countries
- Belgium
Study Locations
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