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

A Randomized, Open-Label, Parallel Group Study of the Pharmacokinetics, Safety, and Tolerability of a Single Intramuscular (IM) Injection of REGN2222 Produced by 2 Different Cell Lines in Healthy Adult Subjects

Primary Objective: Determine blood concentrations of two formulations of REGN2222

Secondary Objective: Assess safety and tolerability of REGN2222

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: REGN2222

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

Contacts and Locations

Study Locations

• United States
  • Florida
    • Daytona Beach, Florida, United States
  • Indiana
    • Evansville, Indiana, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

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; REGN2222 Reference Formulation	Drug: REGN2222
Experimental: Test Drug; REGN2222 Test Formulation	Drug: REGN2222

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Serum REGN2222 concentration-time curve (AUC)	Day 1 to Day 148 (end of study)
Peak REGN2222 concentration (Cmax)	Day 1 to Day 148 (end of study)

Secondary Outcome Measures

Outcome Measure	Time Frame
Treatment-emergent adverse events (TEAEs) from baseline to the end of the study	Day 1 to Day 148 (end of study)
Presence or absence of anti-drug antibody (ADA)	Day 1 to Day 148 (end of study)

Collaborators and Investigators

• Sponsor: Regeneron Pharmaceuticals

Study record dates

Study Major Dates

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

Study Registration Dates

• First Submitted: July 7, 2016
• First Submitted That Met QC Criteria: July 7, 2016
• First Posted (Estimate): July 11, 2016

Study Record Updates

• Last Update Posted (Estimate): November 4, 2016
• Last Update Submitted That Met QC Criteria: November 3, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: R2222-HV-1520