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SAR231893 DP1

Phase 1

Healthy | Monoclonal antibody | Other |Sanofi|Last Updated: Dec 6, 2013

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment30

FDA Designations

No designations recorded

Clinical trial landscape

SAR231893 DP1 · 1 trial · 1 indication

Phase 1 1
NCT01537640Comparison of the Pharmacokinetics and Safety of Two SAR231893 (REGN668) Drug Products in Healthy SubjectsHealthy
COMPLETED30 Analytics
PHASE1COMPLETED
Comparison of the Pharmacokinetics and Safety of Two SAR231893 (REGN668) Drug Products in Healthy Subjects
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Study Endpoints

Primary Endpoints

Assessment of serum concentrations of SAR231893 (REGN668)
Up to 57 Days

Secondary Endpoints

Pain evaluation at injection site using Visual Analog Scale (VAS)
Up to 8 Days
Erythema at injection site by measuring diameter
Up to 8 Days
Edema at injection site by measuring diameter
Up to 8 Days
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
SAR231893 (REGN668) Drug Product (DP) 1EXPERIMENTALSAR231893 (REGN668) Drug Product 1 in a single subcutaneous injection
SAR231893 (REGN668) Drug Product (DP) 2EXPERIMENTALSAR231893 (REGN668) Drug Product 2 in a single subcutaneous injection

Interventions

NameTypeDescription
SAR231893 (REGN668) DP1BIOLOGICALPharmaceutical form:solution Route of administration: subcutaneous
SAR231893 (REGN668) DP2BIOLOGICALPharmaceutical form:solution Route of administration: subcutaneous
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Eligibility Criteria

Age Range18 Years to 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion criteria: * Healthy male and female subjects between 18 and 45 years of age Exclusion criteria: * Presence or history of drug hypersensitivity or allergic disease * History or presence of dermatological disorders * Fever or persistent chronic or active recurring infection requiring trea...

Countries:United States
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Frequently asked questions about SAR231893 DP1

What is SAR231893 DP1 used for?

SAR231893 DP1 is an investigational monoclonal antibody being studied in healthy volunteers. It is currently in Phase 1 clinical development, with a completed trial evaluating its pharmacokinetics and safety in healthy subjects. The drug is not approved for any indication and remains in early-stage clinical testing.

Who makes SAR231893 DP1?

SAR231893 DP1 is being developed by Sanofi, a global biopharmaceutical company listed on the stock exchange under the ticker SNY. The drug is an investigational monoclonal antibody currently in Phase 1 clinical development for use in healthy volunteers.

What phase is SAR231893 DP1 in?

SAR231893 DP1 is in Phase 1 clinical development. A Phase 1 trial has been completed, which studied the pharmacokinetics and safety of the drug in healthy subjects. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is SAR231893 DP1 in?

SAR231893 DP1 has one completed clinical trial, identified as NCT01537640. This Phase 1 study compared the pharmacokinetics and safety of two SAR231893 (REGN668) drug products in 30 healthy subjects in the United States. The trial was randomized, double-blind, and controlled.

Is SAR231893 DP1 the same as REGN668?

SAR231893 DP1 is also known as REGN668, as indicated in the clinical trial title. The Phase 1 study NCT01537640 evaluated two SAR231893 (REGN668) drug products, confirming that these names refer to the same investigational monoclonal antibody being developed by Sanofi.