Study of the Blood Concentrations of Two Formulations of REGN1033 in Healthy Subjects

Regeneron Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: REGN1033

Study type: Interventional

Funder types: Industry

Identifiers

NCT02741739

R1033-HV-1503

Details and patient eligibility

About

Primary Objective: Determine blood concentrations of two formulations of REGN1033.

Secondary Objective: Assess safety and tolerability of REGN1033.

Enrollment: 28 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

1. Healthy males and females (not of childbearing potential) between the ages of 18 and 65 years
2. Body weight between 50.0 kg and 95.0 kg
3. Willing and able to comply with clinic visits and study-related procedures
4. Provide signed informed consent

Key Exclusion Criteria:

1. Donation or loss of approximately 400 mL or more of blood within 8 weeks prior to dosing, or plasma up to 14 days prior to dosing
2. Hemoglobin not within normal limits
3. Positive drug and alcohol screen test results at screening visits 1 and 2
4. Low or elevated blood pressure and/or heart rate after 3 minutes resting in the seated position:
5. Recent use (within 3 months prior to screening) of androgenic steroids
6. 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
7. Previous exposure to any biological therapeutic agent, except vaccines
8. Known sensitivity to tamoxifen, doxycycline, or similar compounds (ie, tetracyclines)
9. Pregnant or breastfeeding women, and women of childbearing potential
10. 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:

REGN1033 Reference Formulation

Treatment:

Drug: REGN1033

Test Drug

Experimental group

Description:

REGN1033 Test Formulation

Treatment:

Drug: REGN1033