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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02828397

Enrollment

Registered

2016-07-11

Start date

2016-04-30

Completion date

2016-09-30

Last updated

2016-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Brief summary

Primary Objective: Determine blood concentrations of two formulations of REGN2222 Secondary Objective: Assess safety and tolerability of REGN2222

Interventions

DRUGREGN2222

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Yes

Inclusion criteria

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

Design outcomes

Primary

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

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)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026