Comparison of the Pharmacokinetics and Safety of Two SAR231893 (REGN668) Drug Products in Healthy Subjects

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01537640

Enrollment

Registered

2012-02-23

Start date

2012-02-29

Completion date

2012-07-31

Last updated

2013-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

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

Detailed description

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.

Interventions

BIOLOGICALSAR231893 (REGN668) DP1

Pharmaceutical form:solution Route of administration: subcutaneous

BIOLOGICALSAR231893 (REGN668) DP2

Pharmaceutical form:solution Route of administration: subcutaneous

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Assessment of serum concentrations of SAR231893 (REGN668)	Up to 57 Days

Secondary

Measure	Time frame
Pain evaluation at injection site using Visual Analog Scale (VAS)	Up to 8 Days
Erythema at injection site by measuring diameter	Up to 8 Days
Edema at injection site by measuring diameter	Up to 8 Days
Number of participants experiencing adverse events	Up to 57 Days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026