Study of the Blood Concentrations of Two Formulations of REGN2222 in Healthy Subjects

Regeneron Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: REGN2222

Study type: Interventional

Funder types: Industry

Identifiers

NCT02828397

R2222-HV-1520

Details and patient eligibility

About

Primary Objective: Determine blood concentrations of two formulations of REGN2222

Secondary Objective: Assess safety and tolerability of REGN2222

Enrollment: 28 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

1. Healthy man or woman aged 18 to 60 years
2. Body weight between 50.0 kg and 95.0 kg, inclusive
3. Willing and able to comply with clinic visits and study-related procedures
4. Provide signed informed consent

Key Exclusion Criteria:

1. Hemoglobin not within normal limits
2. Positive drug and alcohol screen test results at screening visits 1 and 2
3. Participation in any clinical research study that evaluated another investigational drug or therapy within 30 days or at least 5 half-lives, whichever is longer, of the investigational drug, prior to the screening visit
4. Pregnant or breastfeeding women, and women of childbearing potential
5. Sexually active men who are unwilling to practice adequate contraception during the study

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

Reference Drug

Experimental group

Description:

REGN2222 Reference Formulation

Treatment:

Drug: REGN2222

Test Drug

Experimental group

Description:

REGN2222 Test Formulation

Treatment:

Drug: REGN2222