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

A Randomized, Open-Label, Parallel Group Study of the Pharmacokinetics, Safety, and Tolerability of a Single Subcutaneous Dose of REGN1033 Produced From Two Different Cell Lines in Healthy Subjects

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

Secondary Objective: Assess safety and tolerability of REGN1033.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: REGN1033

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Reference Drug; REGN1033 Reference Formulation	Drug: REGN1033
Experimental: Test Drug; REGN1033 Test Formulation	Drug: REGN1033

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Serum REGN1033 concentration-time curve (AUC)	Pre-dose to day 57
Peak REGN1033 concentration (Cmax)	Pre-dose to day 57

Secondary Outcome Measures

Outcome Measure	Time Frame
Treatment-emergent adverse events (TEAEs) from baseline to the end of the study	Day 1 to end of study (Day 57)
Presence or absence of anti-drug antibody (ADA)	Day 1 to end of study (Day 57)

Collaborators and Investigators

• Sponsor: Regeneron Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: April 13, 2016
• First Submitted That Met QC Criteria: April 15, 2016
• First Posted (Estimate): April 18, 2016

Study Record Updates

• Last Update Posted (Estimate): October 14, 2016
• Last Update Submitted That Met QC Criteria: October 13, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: blood; Drug concentration; REGN1033
• Other Study ID Numbers: R1033-HV-1503

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No