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

• Sponsor: Regeneron Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02828397
• Collaborator: (none)
• Enrollment: 28
• Locations: 2
• Arms: 2
• Duration (Months): 5
• Patients Per Site: 14
• Patients Per Site Per Month: 2.8

Study Details

Study Description

Brief Summary

Primary Objective: Determine blood concentrations of two formulations of REGN2222

Secondary Objective: Assess safety and tolerability of REGN2222

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: REGN2222	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 28 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: 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
• Study Start Date: Apr 1, 2016
• Actual Primary Completion Date: Sep 1, 2016
• Actual Study Completion Date: Sep 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Reference Drug REGN2222 Reference Formulation	Drug: REGN2222
Experimental: Test Drug REGN2222 Test Formulation	Drug: REGN2222

Outcome Measures

Primary Outcome Measures

1. Serum REGN2222 concentration-time curve (AUC) [Day 1 to Day 148 (end of study)]

2. Peak REGN2222 concentration (Cmax) [Day 1 to Day 148 (end of study)]

Secondary Outcome Measures

1. Treatment-emergent adverse events (TEAEs) from baseline to the end of the study [Day 1 to Day 148 (end of study)]

2. Presence or absence of anti-drug antibody (ADA) [Day 1 to Day 148 (end of study)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Daytona Beach	Florida	United States
2		Evansville	Indiana	United States

Sponsors and Collaborators

• Regeneron Pharmaceuticals

Investigators

• Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Regeneron Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT02828397
• Other Study ID Numbers: R2222-HV-1520
• First Posted: Jul 11, 2016
• Last Update Posted: Nov 4, 2016
• Last Verified: Nov 1, 2016

Study Results

No Results Posted as of Nov 4, 2016