A Single-Dose Study of the Safety and Tolerability of REGN475(SAR164877) in Healthy Subjects

Regeneron Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Biological: REGN475 (SAR164877)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00856310

R475-PN-0817

Details and patient eligibility

About

This is a randomized, double-blind, placebo-controlled single-dose study of the safety and tolerability of intravenously administered REGN475 in healthy volunteers. The primary objective of the study is to assess the safety and tolerability of REGN475. The secondary objectives are to characterize the pharmacokinetic and immunogenicity profiles of REGN475.

Enrollment: 56 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Male or female volunteers, in general good health and 21 to 65 years of age.
• Female volunteers must be post-menopausal for at least 1 year or surgically sterile.

Key Exclusion Criteria:

• Significant concomitant illness such as, but not limited to, cardiac, renal, neurological, endocrinological, GI, hepatic, metabolic or lymphatic disease that would adversely affect the subject's participation in this study or interpretation of safety/ PK data
• Participation in any clinical research study evaluating another investigational drug or therapy within 3 weeks or at least 5 half-lives of the investigational drug, whichever is longer, prior to the Screening Visit.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

---

56 participants in 7 patient groups

Cohort 1

Active Comparator group

Description:

Dose 1 REGN475

Treatment:

Biological: REGN475 (SAR164877)

Cohort 2

Active Comparator group

Description:

Dose 2 of REGN475

Treatment:

Biological: REGN475 (SAR164877)

Cohort 3

Active Comparator group

Description:

Dose 2 of REGN475

Treatment:

Biological: REGN475 (SAR164877)

Cohort 4

Active Comparator group

Description:

Dose 1 of REGN475

Treatment:

Biological: REGN475 (SAR164877)

Cohort 5

Active Comparator group

Description:

Dose 2 of REGN475

Treatment:

Biological: REGN475 (SAR164877)

Cohort 6

Active Comparator group

Description:

Dose 1 REGN475 subcutaneous administration

Treatment:

Biological: REGN475 (SAR164877)

Cohort 7

Active Comparator group

Description:

Dose 2 REGN475 subcutaneous administration

Treatment:

Biological: REGN475 (SAR164877)