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NCT01537640 · ClinicalTrials.gov registry record · Phase 1
Comparison of the Pharmacokinetics and Safety of Two SAR231893 (REGN668) Drug Products in Healthy Subjects
A Phase 1 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT01537640 is a Phase 1 study that has completed, run by Sanofi. The registered enrollment target is 30 participants.
The verdict
NCT01537640, a Phase 1 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study Summary
Primary Objective: To determine and compare the pharmacokinetic (PK) profiles of 2 different SAR231893 (REGN668) drug products after administration of a single subcutaneous (SC) dose Secondary Objective: To determine and compare the safety and tolerability of the 2 SAR231893 (REGN668) drug products after administration of a single SC dose
Interventions
- BIOLOGICAL SAR231893 (REGN668) DP1
- BIOLOGICAL SAR231893 (REGN668) DP2
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2012-02 |
| Est. Completion | 2012-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01537640
The ClinicalTrials.gov registry entry for NCT01537640 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which SAR231893 (REGN668) DP1 is the first listed.
NCT01537640 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01537640 about?
NCT01537640 is a clinical study titled "Comparison of the Pharmacokinetics and Safety of Two SAR231893 (REGN668) Drug Products in Healthy Subjects". Primary Objective: To determine and compare the pharmacokinetic (PK) profiles of 2 different SAR231893 (REGN668) drug products after administration of a single subcutaneous (SC) dose Secondary Objective: To determine and compare the safety and tolerability of the 2 SAR231893 (REGN668) drug produc...
What is the current status of trial NCT01537640?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2012-02. Estimated completion is 2012-07.
What interventions are being tested in trial NCT01537640?
The interventions under investigation include: SAR231893 (REGN668) DP1 (BIOLOGICAL), SAR231893 (REGN668) DP2 (BIOLOGICAL).
Who is sponsoring clinical trial NCT01537640?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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