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

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

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.

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.