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INO-3401

Phase 1

Undisclosed | Monoclonal antibody | Other |Inovio Pharmaceuticals, Inc.|Trials Updated: Sep 13, 2017

INO-3401 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Jul 2011

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment22

FDA Designations

No designations recorded

INO-3401 clinical trials

INO-3401 · 1 trial · 1 indication

Phase 1 1
NCT01403155A Follow-On Study With an H5 Influenza Vaccine for Subjects Who Participated in Study FLU-001Healthy
COMPLETED22 Analytics
PHASE1COMPLETED
A Follow-On Study With an H5 Influenza Vaccine for Subjects Who Participated in Study FLU-001
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Study Endpoints

Primary Endpoints

Safety
Day 0 through Month 9

Frequency and severity of local and systemic reactogenicity, signs and symptoms, adverse events and serious adverse events.

Secondary Endpoints

Humoral and cellular immune responses
Day 0 through Month 9
Tolerability
Day 0 and Month 3
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposePREVENTION

Treatment Arms

ArmTypeDescription
All subjectsEXPERIMENTALAll subjects will receive 0.9mg/mL of study vaccine (INO-3401 DNA plasmid vaccine) at Day o and Month 3.

Interventions

NameTypeDescription
INO-3401 + EPBIOLOGICALAll subjects will receive 0.9mg/mL of study vaccine (INO-3401 DNA plasmid vaccine)at Day 0 and Month 3.
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Eligibility Criteria

Age Range18 Years to 50 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Written informed consent in accordance with institutional guidelines. If required by local law, candidates must also authorize the release and use of protected health information (PHI); * Enrollment in and received at least one vaccination in study FLU-001; * Adults of either ...

Countries:United States
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Frequently asked questions about INO-3401

What is INO-3401?

INO-3401 is an investigational monoclonal antibody developed by Inovio Pharmaceuticals, Inc. It has been studied in a Phase 1 clinical trial involving healthy adult volunteers. The specific disease indication for INO-3401 has not been publicly disclosed, and the compound remains in early-stage clinical development.

Who makes INO-3401?

INO-3401 is developed by Inovio Pharmaceuticals, Inc., which trades on the Nasdaq under the ticker symbol INO. Inovio is the sponsor of the clinical program evaluating INO-3401, a monoclonal antibody candidate that has completed one Phase 1 study in healthy volunteers.

What phase is INO-3401 in?

INO-3401 is in Phase 1 development. One Phase 1 trial has been completed, and no active trials are currently listed. The study enrolled 22 healthy adult volunteers in the United States. INO-3401 is investigational and has not been approved by the FDA for any indication.

What clinical trials is INO-3401 in?

INO-3401 has been evaluated in one completed Phase 1 trial, NCT01403155, titled a follow-on study with an H5 influenza vaccine for subjects who participated in study FLU-001. The trial enrolled 22 healthy volunteers aged 18 years and older in the United States and was an uncontrolled study.