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NCT01507402 · ClinicalTrials.gov registry record · Phase 1
A Study to Assess the Safety and Tolerability of Single Ascending Doses of REGN1033(SAR391786)
A Phase 1 study of Healthy Volunteers, sponsored by Regeneron Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 76
- Enrollment target
- 2
- Study locations
NCT01507402: Completed Phase 1 study of Healthy Volunteers, sponsored by Regeneron Pharmaceuticals.
NCT01507402 is a Phase 1 study of Healthy Volunteers that has completed, run by Regeneron Pharmaceuticals. The registered enrollment target is 76 participants, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (84% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01507402, a Phase 1 study of Healthy Volunteers, has completed, sponsored by Regeneron Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 76 participants
- Enrollment target
- 2
- Study locations
Study Summary
This is a randomized, double-blind, placebo-controlled, single ascending dose study to assess the safety and tolerability of Intravenous (IV) and Subcutaneous (SC) REGN1033(SAR391786) in healthy volunteers.
Primary Outcome
The primary endpoint in the study is the incidence and severity of TEAEs (Treatment Emergent Adverse Events) in subjects treated with REGN1033 or placebo, reported from the time of administration of study drug on day 1 (baseline) to completion of the study (day 113).
Conditions Studied
Interventions
- DRUG Placebo
- DRUG REGN1033(SAR391786)
Study Locations (2)
Hawaii
- - Honolulu
Indiana
- - Evansville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 76 participants |
| Start Date | 2012-01 |
| Est. Completion | 2012-11 |
| Phase | Phase 1 |
What the finished NCT01507402 record still lists
NCT01507402 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 76 participants, a relatively small participant target, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (84% lower).
The record links to 1 condition, with Healthy Volunteers appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01507402 reports a single indexed study location in Hawaii, Indiana.
Frequently Asked Questions
What is clinical trial NCT01507402 about?
NCT01507402 is a clinical study titled "A Study to Assess the Safety and Tolerability of Single Ascending Doses of REGN1033(SAR391786)". This is a randomized, double-blind, placebo-controlled, single ascending dose study to assess the safety and tolerability of Intravenous (IV) and Subcutaneous (SC) REGN1033(SAR391786) in healthy volunteers.
What is the current status of trial NCT01507402?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 76 participants. The study started on 2012-01. Estimated completion is 2012-11.
What conditions does trial NCT01507402 study?
This clinical trial studies the following conditions: Healthy Volunteers.
What interventions are being tested in trial NCT01507402?
The interventions under investigation include: Placebo (DRUG), REGN1033(SAR391786) (DRUG).
Who is sponsoring clinical trial NCT01507402?
This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01507402 being conducted?
This trial has 2 study locations across Hawaii, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Healthy Volunteers
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01507402's enrollment target sits among peer trials
76 90th of 283 higher than 193 of 283 other Healthy Volunteers trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Volunteers trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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