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AVI-4126

Phase 1

Neoplasms | Small molecule | Oncology |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 Enrollment6

FDA Designations

No designations recorded

Clinical trial landscape

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 used for?

AVI-4126 is an investigational small molecule being studied for the treatment of neoplasms, which are abnormal growths of tissue that can be benign or malignant. It is currently in Phase 1 clinical development for this oncology indication.

Who makes AVI-4126?

AVI-4126 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 oncology candidate.

What phase is AVI-4126 in?

AVI-4126 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed, and the drug remains in early-stage clinical testing for neoplasms.

What clinical trials is AVI-4126 in?

AVI-4126 has one completed clinical trial, registered as NCT00343148. This Phase 1 study was a pharmacokinetic evaluation of a single dose of AVI-4126 in cerebrospinal fluid, enrolling 6 healthy male volunteers in the United States.

Is AVI-4126 the same as RESTEN-NG?

Yes, AVI-4126 is also known as RESTEN-NG. The completed Phase 1 clinical trial NCT00343148 used the name RESTEN-NG in its title, confirming that both names refer to the same investigational drug candidate.