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AVI-4126

Phase 1

Neoplasms | Small molecule | Oncology |Sarepta Therapeutics, Inc.|Trials Updated: Jul 8, 2009

AVI-4126 target and mechanism

ModalitySmall molecule

Also known as AVI-4126 Injection (RESTEN-NG®)

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment6

FDA Designations

No designations recorded

AVI-4126 clinical trials

AVI-4126 · 1 trial · 1 indication

Phase 1 1
NCT00343148Pharmacokinetic Study of a Single Dose of AVI-4126 (RESTEN-NG®) in Cerebral Spinal FluidNeoplasms
COMPLETED6 Analytics
PHASE1COMPLETED
Pharmacokinetic Study of a Single Dose of AVI-4126 (RESTEN-NG®) in Cerebral Spinal Fluid
NeoplasmsUnlock 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-4126 Injection (RESTEN-NG®)DRUG -
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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-4126

What is AVI-4126?

AVI-4126 is an investigational small molecule developed by Sarepta Therapeutics, Inc. (ticker SRPT) for neoplasms in oncology. It is also known as AVI-4126 Injection (RESTEN-NG). It has been studied in a single Phase 1 clinical trial and is not approved for any indication.

What is AVI-4126 used for?

AVI-4126 has been studied in oncology for neoplasms. Its only recorded clinical trial enrolled healthy male volunteers aged 18 years and older in the United States, so the work to date has focused on early pharmacokinetic evaluation rather than treatment of patients with cancer.

Who makes AVI-4126?

AVI-4126 is developed by Sarepta Therapeutics, Inc., which trades under the ticker SRPT. Sarepta is the sponsor associated with the drug's clinical program in oncology.

What phase is AVI-4126 in?

AVI-4126 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 trials are currently active.

What clinical trials is AVI-4126 in?

AVI-4126 has been evaluated in one completed Phase 1 trial, NCT00343148, titled "Pharmacokinetic Study of a Single Dose of AVI-4126 (RESTEN-NG) in Cerebral Spinal Fluid." It enrolled 6 participants in the United States and was an uncontrolled study without randomization or blinding.

Is AVI-4126 the same as RESTEN-NG?

Yes. AVI-4126 is also known as AVI-4126 Injection (RESTEN-NG). RESTEN-NG is the alternate name used for the same investigational agent, including in the title of its completed Phase 1 pharmacokinetic trial, NCT00343148.