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REGN2222

Phase 1

Healthy Volunteers | Small molecule | Other |Regeneron Pharmaceuticals, Inc.|Last Updated: Nov 4, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials2
Total Enrollment160

FDA Designations

No designations recorded

Clinical trial landscape

REGN2222 · 2 trials · 1 indication

Phase 1 2
NCT02828397Study of the Blood Concentrations of Two Formulations of REGN2222 in Healthy SubjectsHealthy Volunteers
COMPLETED28 Analytics
NCT02121080Study of the Safety and Tolerability of REGN2222(SAR438584) in Healthy Adult VolunteersHealthy Volunteers
COMPLETED132 Analytics
PHASE1COMPLETED
Study of the Blood Concentrations of Two Formulations of REGN2222 in Healthy Subjects
Healthy VolunteersUnlock trial analytics
PHASE1COMPLETED
Study of the Safety and Tolerability of REGN2222(SAR438584) in Healthy Adult Volunteers
Healthy VolunteersUnlock trial analytics

Study Endpoints

Primary Endpoints

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)
The incidence and severity of treatment-emergent adverse events (TEAEs) in participants treated with REGN2222 or placebo.
from day 1 up to week 20 (EOS)

Secondary Endpoints

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)
Serum concentration
from day 1 over time up to week 20
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Reference DrugEXPERIMENTALREGN2222 Reference Formulation
Test DrugEXPERIMENTALREGN2222 Test Formulation
Cohort 1EXPERIMENTALDosing regimen 1
Cohort 2EXPERIMENTALDosing regimen 2
Cohort 3EXPERIMENTALDosing regimen 3
Cohort 4EXPERIMENTALDosing regimen 4
Cohort 5EXPERIMENTALDosing regimen 5

Interventions

NameTypeDescription
REGN2222DRUG -
REGN2222(SAR438584)DRUG -
placeboDRUG -
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Eligibility Criteria

Age Range18 Years to 60 Years
SexALL
Healthy VolunteersYes
Study Sites2

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...

Countries:United States
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Frequently asked questions about REGN2222

What is REGN2222 used for?

REGN2222 is an investigational small molecule being studied in healthy volunteers. It is in Phase 1 clinical development, with completed trials assessing its safety, tolerability, and blood concentrations. It is not approved for any condition and remains in early-stage clinical testing.

Who makes REGN2222?

REGN2222 is being developed by Regeneron Pharmaceuticals, Inc., a biopharmaceutical company traded on NASDAQ under the ticker REGN. The company is conducting Phase 1 studies of this investigational small molecule in healthy volunteers.

What phase is REGN2222 in?

REGN2222 is in Phase 1 clinical development. Two Phase 1 trials have been completed, both involving healthy volunteers. The drug is investigational and has not been approved by regulatory authorities, as it is still in early-stage clinical testing.

What clinical trials is REGN2222 in?

REGN2222 has two completed Phase 1 trials. NCT02121080 studied safety and tolerability in 132 healthy adults, and NCT02828397 studied blood concentrations of two formulations in 28 healthy subjects. Both trials were conducted in the United States with participants aged 18 years and older.

Is REGN2222 the same as SAR438584?

Yes, REGN2222 is also known as SAR438584. The first clinical trial, NCT02121080, is titled 'Study of the Safety and Tolerability of REGN2222(SAR438584) in Healthy Adult Volunteers,' confirming that both names refer to the same investigational drug.