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REGN668: Rate 1

Phase 1

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

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
HealthyUnlock trial analytics

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 used for?

REGN668 is an investigational small molecule being studied in healthy volunteers. It is currently in Phase 1 clinical development, with a completed trial assessing its safety, tolerability, pharmacokinetics, and immunogenicity when administered subcutaneously. It is not approved for any indication.

Who makes REGN668?

REGN668 is being developed by Regeneron Pharmaceuticals, Inc., a biopharmaceutical company traded on NASDAQ under the ticker REGN. The company conducted a Phase 1 study of REGN668 in healthy volunteers in the United States.

What phase is REGN668 in?

REGN668 is in Phase 1 clinical development. The only trial listed for REGN668 is a completed Phase 1 study. It is an investigational drug and has not been approved by regulatory authorities.

What clinical trials is REGN668 in?

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

Is REGN668 a randomized controlled trial?

The Phase 1 trial of REGN668, NCT01484600, was randomized and controlled, but it was not double-blind. The study enrolled healthy volunteers aged 18 years and older, with a total enrollment of 36 participants.