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SAR231893 DP1

Phase 1

Undisclosed | Monoclonal antibody | Other |Sanofi|Trials Updated: Dec 6, 2013

SAR231893 DP1 target and mechanism

ModalityMonoclonal antibody

Also known as SAR231893 (REGN668) DP1

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

SAR231893 DP1 clinical trials

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?

SAR231893 DP1 is an investigational monoclonal antibody developed by Sanofi. It is a drug product form of SAR231893 (REGN668) that has been studied in a Phase 1 clinical trial in healthy adult volunteers. No therapeutic indication has been disclosed for this asset.

Who is developing SAR231893 DP1?

SAR231893 DP1 is being developed by Sanofi, which trades under the ticker SNY. The compound is also referred to as SAR231893 (REGN668) DP1, reflecting its origin as a SAR231893 (REGN668) drug product.

What phase is SAR231893 DP1 in?

SAR231893 DP1 is in Phase 1 development. It is investigational and has not been approved by the FDA. One Phase 1 trial has been completed, and no active trials are currently listed for this drug product.

What clinical trials is SAR231893 DP1 in?

SAR231893 DP1 has been evaluated in one completed Phase 1 trial, NCT01537640, titled Comparison of the Pharmacokinetics and Safety of Two SAR231893 (REGN668) Drug Products in Healthy Subjects. The trial enrolled 30 healthy adult volunteers in the United States and used a randomized, double-blind, controlled design.

Is SAR231893 DP1 the same as SAR231893 (REGN668) DP1?

Yes. SAR231893 DP1 and SAR231893 (REGN668) DP1 refer to the same Sanofi drug product. The longer name identifies the underlying SAR231893 (REGN668) antibody, while DP1 denotes the specific drug product formulation studied in the Phase 1 pharmacokinetic comparison trial.

What was studied in the SAR231893 DP1 Phase 1 trial?

The completed Phase 1 trial NCT01537640 compared the pharmacokinetics and safety of two SAR231893 (REGN668) drug products in healthy subjects. It enrolled 30 participants aged 18 years and older, was randomized, double-blind, and controlled, and was conducted in the United States.