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AVI-4065

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment12

FDA Designations

No designations recorded

Clinical trial landscape

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 used for?

AVI-4065 is an investigational small molecule being developed for encephalitis, a neurological condition. It is currently in Phase 1 clinical development. The drug is being studied for its pharmacokinetic properties in the cerebral spinal fluid, with a completed trial involving healthy male volunteers.

Who makes AVI-4065?

AVI-4065 is being developed by Sarepta Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol SRPT. The company is conducting clinical research on this investigational small molecule for the treatment of encephalitis.

What phase is AVI-4065 in?

AVI-4065 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. A single Phase 1 trial has been completed, and the drug is not currently in any active clinical trials.

What clinical trials is AVI-4065 in?

AVI-4065 has one completed clinical trial, identified as NCT00381433. This was a Phase 1 pharmacokinetic study of a single dose of AVI-4065 in cerebral spinal fluid, conducted in the United States with 12 healthy male volunteers aged 18 years and older.

Is AVI-4065 FDA approved?

AVI-4065 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The completed trial, NCT00381433, was a pharmacokinetic study, and the drug has not yet progressed to later-stage trials or received regulatory approval.