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AVI-4065

Phase 1

Encephalitis | Small molecule | Neurology |Sarepta Therapeutics, Inc.|Trials Updated: Jul 8, 2009

AVI-4065 target and mechanism

ModalitySmall molecule

Also known as AVI-4065 Injection

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment12

FDA Designations

No designations recorded

AVI-4065 clinical trials

AVI-4065 · 1 trial · 1 indication

Phase 1 1
NCT00381433Pharmacokinetic Study of a Single Dose of AVI-4065 in Cerebral Spinal FluidEncephalitis
COMPLETED12 Analytics
PHASE1COMPLETED
Pharmacokinetic Study of a Single Dose of AVI-4065 in Cerebral Spinal Fluid
EncephalitisUnlock trial analytics

Study Endpoints

Primary Endpoints

To determine if the study drug penetrates the blood brain barrier following a single intravenous dose, and if so, the associated CSF, plasma and urine pharmacokinetics.

Secondary Endpoints

Safety
Tolerability
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Interventions

NameTypeDescription
AVI-4065 InjectionDRUG -
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Eligibility Criteria

Age Range18 Years to 64 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Adult males 18 years to 64 years of age; * Good general health (as evidenced by no chronic conditions, normal physical exam, vital signs within normal limits; laboratory evaluations within normal range) * Signed and dated written informed consent form; and * Willing to partici...

Countries:United States
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Frequently asked questions about AVI-4065

What is AVI-4065?

AVI-4065 is an investigational small molecule being developed by Sarepta Therapeutics, Inc. (ticker: SRPT) for encephalitis, a neurological condition. It is in Phase 1 clinical development and has been studied in a single completed trial. AVI-4065 is also known as AVI-4065 Injection.

What is AVI-4065 used for?

AVI-4065 is being studied for encephalitis, a neurological condition. It is an investigational therapy and has not been approved for any indication. The only clinical trial of AVI-4065 enrolled healthy volunteers, not patients with encephalitis.

Who makes AVI-4065?

AVI-4065 is being developed by Sarepta Therapeutics, Inc., which trades under the ticker SRPT. Sarepta is the sponsor of the clinical program for AVI-4065.

What phase is AVI-4065 in?

AVI-4065 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The Phase 1 program consists of one completed trial, and no active trials are currently listed.

What clinical trials is AVI-4065 in?

AVI-4065 has been studied in one completed Phase 1 trial, NCT00381433, titled "Pharmacokinetic Study of a Single Dose of AVI-4065 in Cerebral Spinal Fluid." The trial enrolled 12 healthy male volunteers in the United States and was uncontrolled, with no randomization or blinding.

Is AVI-4065 the same as AVI-4065 Injection?

Yes, AVI-4065 Injection is an alternative name for AVI-4065. Both refer to the same investigational small molecule developed by Sarepta Therapeutics, Inc. (ticker: SRPT) for encephalitis.