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BAF 312

Phase 1

Healthy | Small molecule | Other |Novartis AG|Last Updated: Nov 29, 2007

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment63

FDA Designations

No designations recorded

Clinical trial landscape

BAF 312 · 1 trial · 1 indication

Phase 1 1
NCT00422175Single Dose Study to Assess the Safety, Tolerability, Concentration in Body and Effect of BAF312Healthy
COMPLETED63 Analytics
PHASE1COMPLETED
Single Dose Study to Assess the Safety, Tolerability, Concentration in Body and Effect of BAF312
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Study Endpoints

Primary Endpoints

safety, tolerability, and pharmacokinetic profile
Maximum Tolerated Dose

Secondary Endpoints

Lymphocyte counts and lymphocyte recovery period
Cardiac rate and rhythm
Pulmonary function
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
BAF 312DRUG -
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male and female subjects, 18 to 55 years of age included, and in good health * Female subjects must be either surgically sterilized at least 6 months prior to study participation or post-menopausal (no regular menstrual bleeding for at least 1 years) * Female subjects ...

Countries:United States
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Frequently asked questions about BAF 312

What is BAF 312 used for?

BAF 312 is an investigational small molecule being studied for multiple conditions, including relapsing-remitting multiple sclerosis, secondary progressive multiple sclerosis, hepatic impairment, renal impairment, hemorrhagic stroke, and in healthy volunteers. It is being developed by Novartis AG.

What does BAF 312 target?

BAF 312 is a small molecule that acts as a sphingosine 1-phosphate receptor modulator. It is being studied for its potential effects on immune cell trafficking in conditions like multiple sclerosis and hemorrhagic stroke.

Who makes BAF 312?

BAF 312 is being developed by Novartis AG, a global healthcare company traded on the New York Stock Exchange under the ticker NVS. Novartis is conducting clinical trials to evaluate the drug's safety and efficacy across several indications.

What phase is BAF 312 in?

BAF 312 is in clinical development. It has completed Phase 1, Phase 2, and Phase 3 trials. The most advanced completed trial was a Phase 3 study in secondary progressive multiple sclerosis, while earlier-phase studies covered hepatic impairment and relapsing-remitting multiple sclerosis.

What clinical trials is BAF 312 in?

BAF 312 has been studied in several completed trials. NCT01185821 was a Phase 2 study in relapsing-remitting multiple sclerosis. NCT01565902 was a Phase 1 pharmacokinetic study in hepatic impairment. NCT01665144 was a Phase 3 trial in secondary progressive multiple sclerosis, and NCT03338998 was a Phase 2 study in intracerebral hemorrhage.

Is BAF 312 the same as siponimod?

Yes, BAF 312 is also known as siponimod. In clinical trials, it has been referred to by both names, including in the EXPAND study for secondary progressive multiple sclerosis, which evaluated siponimod in over 1,600 patients.