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REGN668: Rate 1

Phase 1

Undisclosed | Small Molecules | Other |Regeneron Pharmaceuticals, Inc.|Trials Updated: Mar 14, 2012

REGN668: Rate 1 target and mechanism

ModalitySmall Molecules

Also known as REGN668: Injection Rate 1

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLEDDMC
Total Trials1
Total Enrollment36

FDA Designations

No designations recorded

REGN668: Rate 1 clinical trials

REGN668: Rate 1 · 1 trial · 1 indication

Phase 1 1
NCT01484600Study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of REGN668 Administered Subcutaneously to Healthy VolunteersHealthy
COMPLETED36 Analytics
PHASE1COMPLETED
Study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of REGN668 Administered Subcutaneously to Healthy Volunteers
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Study Endpoints

Primary Endpoints

Incidence and severity of treatment-emergent adverse events (TEAEs)
Baseline through day 64 (end of study)

Secondary Endpoints

Pharmacokinetic (PK) profile of REGN668
Baseline through day 64
Incidence of anti-REGN668 antibodies
Day 29 and Day 64
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Group 1EXPERIMENTAL -
Group 2EXPERIMENTAL -

Interventions

NameTypeDescription
REGN668: Injection Rate 1DRUGSubjects will receive REGN668 via SC injection
REGN668: Injection Rate 2DRUGSubjects will receive study drug via alternate delivery (if necessary)
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Male or female subjects 18 to 55 years of age. 2. Body weight between 60 kg and 80 kg, body mass index between 20 and 30 kg/m2 inclusive. 3. NHV as evidenced by comprehensive clinical assessment (detailed medical history and complete physical examination). 4. Normal resting b...

Countries:United States
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Frequently asked questions about REGN668: Rate 1

What is REGN668?

REGN668 is an investigational small molecule developed by Regeneron Pharmaceuticals, Inc. It has been studied in a Phase 1 clinical trial in healthy adult volunteers in the United States. REGN668 is also known as REGN668: Injection Rate 1.

Who makes REGN668?

REGN668 is being developed by Regeneron Pharmaceuticals, Inc., which trades on the Nasdaq under the ticker REGN. Regeneron sponsored the Phase 1 study of REGN668 conducted in the United States.

What phase is REGN668 in?

REGN668 is in Phase 1 development. Its only recorded clinical trial, NCT01484600, was a Phase 1 study that has been completed. REGN668 is investigational and has not been approved by the FDA.

What clinical trials is REGN668 in?

REGN668 has been studied in one clinical trial, NCT01484600, titled "Study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of REGN668 Administered Subcutaneously to Healthy Volunteers." The Phase 1 trial enrolled 36 healthy volunteers in the United States and is completed.

Is REGN668 the same as REGN668: Injection Rate 1?

Yes, REGN668: Injection Rate 1 is an alternative name for REGN668. Both names refer to the same investigational small molecule developed by Regeneron Pharmaceuticals, Inc. for subcutaneous administration.

How was the REGN668 Phase 1 trial designed?

The REGN668 Phase 1 trial, NCT01484600, was a randomized, controlled study that enrolled 36 healthy volunteers aged 18 years and older in the United States. It evaluated safety, tolerability, pharmacokinetics, and immunogenicity of subcutaneous REGN668 and is completed.