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NCT01443650 · ClinicalTrials.gov registry record · Phase 1

Injection Site Tolerability, Safety, Pharmacokinetics, Pharmacodynamics in Different Single-Dose Treatments of Alirocumab SAR236553 (REGN727) in Healthy Subjects

A Phase 1 study, sponsored by Sanofi.

Completed
Registry status
Phase 1
Development phase
36
Enrollment target

NCT01443650: Completed Phase 1 study, sponsored by Sanofi.

NCT01443650 is a Phase 1 study that has completed, run by Sanofi. The registered enrollment target is 36 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01443650, a Phase 1 study, has completed, sponsored by Sanofi.

COMPLETED
Registry status
Phase 1
Development phase
36 participants
Enrollment target

Study Summary

Primary Objective: Injection Site Tolerability Secondary Objectives: * To assess the safety profile of alirocumab SAR236553 (REGN727) * To assess the pharmacokinetic-pharmacodynamic relationship of alirocumab SAR236553 (REGN727)

Interventions

  • DRUG alirocumab SAR236553 (REGN727)

Trial Details

FieldValue
Enrollment Target 36 participants
Start Date 2011-07
Est. Completion 2011-11
Phase Phase 1
Sanofi

713 total trials

What the finished NCT01443650 record still lists

NCT01443650 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower).

The record links to 0 conditions, and to 1 intervention - of which alirocumab SAR236553 (REGN727) is the first listed.

NCT01443650 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01443650 about?

NCT01443650 is a clinical study titled "Injection Site Tolerability, Safety, Pharmacokinetics, Pharmacodynamics in Different Single-Dose Treatments of Alirocumab SAR236553 (REGN727) in Healthy Subjects". Primary Objective: Injection Site Tolerability Secondary Objectives: * To assess the safety profile of alirocumab SAR236553 (REGN727) * To assess the pharmacokinetic-pharmacodynamic relationship of alirocumab SAR236553 (REGN727)

What is the current status of trial NCT01443650?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2011-07. Estimated completion is 2011-11.

What interventions are being tested in trial NCT01443650?

The interventions under investigation include: alirocumab SAR236553 (REGN727) (DRUG).

Who is sponsoring clinical trial NCT01443650?

This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01443650's enrollment target sits among peer trials

36 1210th of 2000 higher than 743 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01443650, the US trial registry maintained by the National Library of Medicine. NCT01443650 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.