This trial has been completed.

Condition healthy volunteers
Treatment regn2222
Phase phase 1
Sponsor Regeneron Pharmaceuticals
Start date April 2016
End date September 2016
Trial size 28 participants
Trial identifier NCT02828397, R2222-HV-1520


Primary Objective: Determine blood concentrations of two formulations of REGN2222

Secondary Objective: Assess safety and tolerability of REGN2222

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification pharmacokinetics study
Intervention model parallel assignment
Masking open label
Primary purpose basic science
REGN2222 Reference Formulation
REGN2222 Test Formulation

Primary Outcomes

Serum REGN2222 concentration-time curve (AUC)
time frame: Day 1 to Day 148 (end of study)
Peak REGN2222 concentration (Cmax)
time frame: Day 1 to Day 148 (end of study)

Secondary Outcomes

Treatment-emergent adverse events (TEAEs) from baseline to the end of the study
time frame: Day 1 to Day 148 (end of study)
Presence or absence of anti-drug antibody (ADA)
time frame: Day 1 to Day 148 (end of study)

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Regeneron Pharmaceuticals.