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REGN668: Rate 1

Phase 1

Healthy | Small molecule | Other |Regeneron Pharmaceuticals, Inc.|Last Updated: Mar 14, 2012

Target and mechanism

ModalitySmall molecule

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

Clinical trial landscape

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: Rate 1?

REGN668: Rate 1 is an investigational small molecule developed by Regeneron Pharmaceuticals, Inc. (ticker REGN). It has been studied in a Phase 1 clinical trial in healthy adult volunteers, evaluating safety, tolerability, pharmacokinetics, and immunogenicity when administered subcutaneously. It is not an approved therapy and remains in clinical development.

Who makes REGN668: Rate 1?

REGN668: Rate 1 is developed by Regeneron Pharmaceuticals, Inc., which trades under the ticker REGN. Regeneron sponsored the Phase 1 study of the compound in healthy volunteers conducted in the United States.

What phase is REGN668: Rate 1 in?

REGN668: Rate 1 is in Phase 1 clinical development. Its single recorded trial, NCT01484600, was a Phase 1 study that has been completed. The drug is investigational and has not been approved for any indication.

What clinical trials is REGN668: Rate 1 in?

REGN668: Rate 1 has been evaluated in one clinical trial, NCT01484600, titled a study of the safety, tolerability, pharmacokinetics, and immunogenicity of REGN668 administered subcutaneously to healthy volunteers. The Phase 1 trial enrolled 36 participants in the United States and is completed.

Is REGN668: Rate 1 the same as REGN668: Injection Rate 1?

Yes, REGN668: Rate 1 is also known as REGN668: Injection Rate 1. Both names refer to the same Regeneron Pharmaceuticals compound studied in the Phase 1 trial NCT01484600 in healthy volunteers.

What is REGN668: Rate 1 used for?

REGN668: Rate 1 has been studied in healthy adult volunteers rather than in a patient population. Its completed Phase 1 trial, NCT01484600, assessed safety, tolerability, pharmacokinetics, and immunogenicity of subcutaneous administration in 36 participants. No approved therapeutic use has been established.