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NCT01893528 · ClinicalTrials.gov registry record · Phase 1

Study to Assess the Safety and Tolerability of Ascending Single Doses of REGN2009 in Healthy Volunteers

A Phase 1 study of Healthy Volunteers, sponsored by Regeneron Pharmaceuticals.

Completed
Registry status
Phase 1
Development phase
49
Enrollment target
2
Study locations

NCT01893528 is a Phase 1 study of Healthy Volunteers that has completed, run by Regeneron Pharmaceuticals. The registered enrollment target is 49 participants, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (90% lower). The trial reports 2 study locations across 2 states.

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The verdict

NCT01893528, a Phase 1 study of Healthy Volunteers, has completed, sponsored by Regeneron Pharmaceuticals.

COMPLETED
Registry status
Phase 1
Development phase
49 participants
Enrollment target
2
Study locations

Study Summary

This is a phase 1, randomized, double-blind, placebo-controlled first-in-human (FIH) study to assess the safety and tolerability of ascending single doses of REGN2009 administered to healthy volunteers.

Conditions Studied

Interventions

  • OTHER placebo
  • DRUG REGN2009

Study Locations (2)

Maryland

  • - Baltimore

Ohio

  • - Cincinnati

Trial Details

FieldValue
Enrollment Target 49 participants
Start Date 2013-06
Est. Completion 2014-09
Phase Phase 1

Sponsor

Regeneron Pharmaceuticals

280 total trials

What the Registry Record Tells You About NCT01893528

The ClinicalTrials.gov registry entry for NCT01893528 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 49 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (90% lower). The listed sponsor is Regeneron Pharmaceuticals, which has 280 total studies on file at ClinicalTrials.gov.

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.

NCT01893528 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Maryland, Ohio.

Frequently Asked Questions

What is clinical trial NCT01893528 about?

NCT01893528 is a clinical study titled "Study to Assess the Safety and Tolerability of Ascending Single Doses of REGN2009 in Healthy Volunteers". This is a phase 1, randomized, double-blind, placebo-controlled first-in-human (FIH) study to assess the safety and tolerability of ascending single doses of REGN2009 administered to healthy volunteers.

What is the current status of trial NCT01893528?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 49 participants. The study started on 2013-06. Estimated completion is 2014-09.

What conditions does trial NCT01893528 study?

This clinical trial studies the following conditions: Healthy Volunteers.

What interventions are being tested in trial NCT01893528?

The interventions under investigation include: placebo (OTHER), REGN2009 (DRUG).

Who is sponsoring clinical trial NCT01893528?

This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01893528 being conducted?

This trial has 2 study locations across Maryland, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.