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OpenTrials
Completed

NCT Number: NCT01537640

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 products after administration of a single SC dose

Completed

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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Investigational Site Number 840001

Daytona Beach, Florida, 32117, United States

About this study

The duration of the study for each subject is 8-11 weeks broken down as follows:

  • Screening: 2 to 21 days,
  • Treatment: 1 day (2 overnight stays at the study site),
  • Follow-up: up to 2 months after dosing.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy male and female subjects between 18 and 45 years of age

Exclusion criteria

  • Presence or history of drug hypersensitivity or allergic disease
  • History or presence of dermatological disorders
  • Fever or persistent chronic or active recurring infection requiring treatment within 4 weeks prior to screening, or history of frequent recurrent infections
  • Prior opportunistic infections within 6 months before inclusion
  • History or presence of listeriosis or tuberculosis
  • Any vaccination within 3 months (1 month for influenza vaccine) before inclusion
  • Any biologics given within 4 months before inclusion
  • Recent history of a parasitic infection or travel to a parasitic endemic area within 6 months prior to screening

The above information is not intended to contain all considerations relevant to a subject's potential participation in a clinical trial.

Treatment and study plan

SAR231893 (REGN668) DP1

Biological

Pharmaceutical form:solution Route of administration: subcutaneous

SAR231893 (REGN668) DP2

Biological

Pharmaceutical form:solution Route of administration: subcutaneous

Primary outcomes

  1. Assessment of serum concentrations of SAR231893 (REGN668)

    Time frame: Up to 57 Days

Secondary outcomes

  1. Pain evaluation at injection site using Visual Analog Scale (VAS)

    Time frame: Up to 8 Days

  2. Erythema at injection site by measuring diameter

    Time frame: Up to 8 Days

  3. Edema at injection site by measuring diameter

    Time frame: Up to 8 Days

  4. Number of participants experiencing adverse events

    Time frame: Up to 57 Days

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Collaborators

  • Regeneron Pharmaceuticals

Registry information

Official study title

A Randomized, Double-Blind, Parallel Group Study of the Pharmacokinetics, Safety, and Tolerability of Two Different SAR231893 Drug Products After Administration of a Single Subcutaneous Dose to Healthy Subjects

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Feb 23, 2012
Registry last updated
Dec 6, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.