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

Sanofi

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Biological: SAR231893 (REGN668) DP1; Biological: SAR231893 (REGN668) DP2

Study type: Interventional

Funder types: Industry

Identifiers

NCT01537640

U1111-1119-3152 (Other Identifier)

PKM12350

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups

SAR231893 (REGN668) Drug Product (DP) 1

Experimental group

Description:

SAR231893 (REGN668) Drug Product 1 in a single subcutaneous injection

Treatment:

Biological: SAR231893 (REGN668) DP1

SAR231893 (REGN668) Drug Product (DP) 2

Experimental group

Description:

SAR231893 (REGN668) Drug Product 2 in a single subcutaneous injection

Treatment:

Biological: SAR231893 (REGN668) DP2