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NCT01026597 · ClinicalTrials.gov registry record · Phase 1
Ascending Dose Study of the Safety and Tolerability of REGN727(SAR236553) in Healthy Volunteers
A Phase 1 study, sponsored by Regeneron Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
NCT01026597 is a Phase 1 study that has completed, run by Regeneron Pharmaceuticals. The registered enrollment target is 40 participants.
The verdict
NCT01026597, a Phase 1 study, has completed, sponsored by Regeneron Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
Study Summary
This study will test the safety and tolerability (how the body reacts to the drug) of REGN727 compared with placebo (an inactive substance that contains no medicine) in healthy subjects. The study drug and placebo will be administered by intravenous (I.V) infusion at one clinic visit. There will be 14 clinic visits, which will include 4 overnight stays. Subjects will be monitored by the study staff for side effects and the body's response to the study drug. Vital signs(blood pressure, temperature, breathing and heart rate) will be checked, and blood and urine samples will be collected at some or all visits.
Interventions
- DRUG Placebo
- DRUG REGN727
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2009-11 |
| Est. Completion | 2010-10 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01026597
The ClinicalTrials.gov registry entry for NCT01026597 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Regeneron Pharmaceuticals, which has 280 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01026597 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01026597 about?
NCT01026597 is a clinical study titled "Ascending Dose Study of the Safety and Tolerability of REGN727(SAR236553) in Healthy Volunteers". This study will test the safety and tolerability (how the body reacts to the drug) of REGN727 compared with placebo (an inactive substance that contains no medicine) in healthy subjects. The study drug and placebo will be administered by intravenous (I.V) infusion at one clinic visit. There will be ...
What is the current status of trial NCT01026597?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2009-11. Estimated completion is 2010-10.
What interventions are being tested in trial NCT01026597?
The interventions under investigation include: Placebo (DRUG), REGN727 (DRUG).
Who is sponsoring clinical trial NCT01026597?
This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.
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