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SAR231893

Phase 1

Healthy | Small molecule | Other |Sanofi|Last Updated: Dec 6, 2013

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment32

FDA Designations

No designations recorded

Clinical trial landscape

SAR231893 · 1 trial · 1 indication

Phase 1 1
NCT01537653Safety, Tolerability and Pharmacokinetics of SAR231893 (REGN668) in Healthy Japanese Adult Male SubjectsHealthy
COMPLETED32 Analytics
PHASE1COMPLETED
Safety, Tolerability and Pharmacokinetics of SAR231893 (REGN668) in Healthy Japanese Adult Male Subjects
Healthy
NCT0153765332
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Study Endpoints

Primary Endpoints

Number of subjects with standard safety assessments (adverse events, physical examinations, 12 lead ECGs, vital signs and laboratory tests)
Up to 57 days

Secondary Endpoints

Pharmacokinetics: Serum concentrations of SAR231893 (REGN668) over time
Up to 57 days
Pharmacodynamics: Serum total Immunoglobulin E (IgE) and Thymus and activation regulated chemokine (TARC) over time
Up to 57 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
SAR231893 (REGN668), Dose Level 4EXPERIMENTALDose Level 4
PlaceboPLACEBO_COMPARATORPlacebo
SAR231893 (REGN668), Dose Level 1EXPERIMENTALDose Level 1
SAR231893 (REGN668), Dose Level 2EXPERIMENTALDose Level 2
SAR231893 (REGN668), Dose Level 3EXPERIMENTALDose Level 3

Interventions

NameTypeDescription
SAR231893 (REGN668)DRUGPharmaceutical form:Solution in a vial Route of administration: Subcutaneous injection
placeboDRUGPharmaceutical form:Solution in a vial Route of administration: Subcutaneous injection
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Eligibility Criteria

Age Range20 Years to 45 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion criteria: * Japanese adult male subjects, between 20 and 45 years of age, inclusive. * Body weight between 50.0 and 95.0 kg, inclusive, body mass index between 18.0 and 28.0 kg/m2, inclusive. * Certified as healthy by a comprehensive clinical assessment. * Having given written informed co...

Countries:Japan
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Frequently asked questions about SAR231893

What is SAR231893 used for?

SAR231893 is an investigational small molecule being studied for use in healthy volunteers. It is currently in Phase 1 clinical development, with trials focused on evaluating its safety, tolerability, and pharmacokinetics in healthy adult subjects. The drug is not approved for any condition and remains in early-stage clinical testing.

Who makes SAR231893?

SAR231893 is being developed by Sanofi, a biopharmaceutical company traded under the ticker SNY. The drug is currently in Phase 1 clinical development, with an ongoing research program focused on evaluating its safety and pharmacokinetic profile in healthy volunteers.

What phase is SAR231893 in?

SAR231893 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the drug is still in the early stages of clinical testing.

What clinical trials is SAR231893 in?

SAR231893 has one completed Phase 1 clinical trial, identified as NCT01537653. This study evaluated the safety, tolerability, and pharmacokinetics of SAR231893 in healthy Japanese adult male subjects. The trial enrolled 32 participants and was conducted in Japan.

Is SAR231893 the same as REGN668?

Yes, SAR231893 is also known as REGN668. The clinical trial NCT01537653, which evaluated the safety, tolerability, and pharmacokinetics of SAR231893, also refers to the drug as REGN668. Both names refer to the same investigational drug being developed by Sanofi.