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INO-3605

Phase 1

Undisclosed | Monoclonal antibody | Other |Inovio Pharmaceuticals, Inc.|Trials Updated: Mar 3, 2014

INO-3605 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

ACTIVE_CONTROLLED
Total Trials1
Total Enrollment116

FDA Designations

No designations recorded

INO-3605 clinical trials

INO-3605 · 1 trial · 1 indication

Phase 1 1
NCT01405885A Study of DNA Vaccine With Electroporation for the Prevention of Disease Caused by H1 and H5 Influenza VirusHealthy
COMPLETED116 Analytics
PHASE1COMPLETED
A Study of DNA Vaccine With Electroporation for the Prevention of Disease Caused by H1 and H5 Influenza Virus
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety and tolerability of nine different formulation of multiple combination of H1 and H5 HA plasmid administered ID followed by electroporation in healthy adult subjects
Day 0 through Month 12

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 12
tolerability and immunogenicity of multiple formulations of H1 and H5 HA plasmids administered ID followed by electroporation to seasonal influenza vaccine
Day 0 through Month 12
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Arm A - 0.9mg of INO-3605EXPERIMENTAL -
Arm B - 0.9mg of INO-3609EXPERIMENTAL -
Arm C- 0.9mg of INO-3401EXPERIMENTAL -
Arm D- 0.3mg of INO-3609EXPERIMENTAL -
Arm E - 0.45mg each INO-3605 , INO-3609EXPERIMENTAL -
Arm F - 0.3mg each of INO-3401,INO-3605,INO-3609EXPERIMENTAL -
Arm G - 0.9mg of INO-3609EXPERIMENTAL -
Arm H - 0.9mg of INO-3609EXPERIMENTAL -
Arm I - Seasonal influenza vaccineACTIVE_COMPARATOR -
Arm J - 1.8mg of INO-3609EXPERIMENTAL -

Interventions

NameTypeDescription
INO-3605BIOLOGICAL0.9mg of INO-3605 vaccine delivered ID followed by electroporation on Day 0, Week 8 and 24.
INO-3609BIOLOGICAL0.9mg of INO-3609 vaccine delivered ID followed by electroporation on Day 0, Week 8 and 24.
INO-3401BIOLOGICAL0.9mg of 3401 vaccine delivered ID followed by electroporation on Day 0, Week 8 and 24.
INO-3605 AND INO-3609BIOLOGICAL0.45mg each of INO-3605 AND INO-3609 vaccine delivered ID followed by electroporation on Day 0, Week 8 and 24.
INO-3510BIOLOGICAL0.3mg each of INO-3605, INO-3609 AND INO-3401 vaccine delivered ID followed by electroporation on Day 0, Week 8 and 24.
Seasonal Influenza vaccineBIOLOGICAL0.5ml of vaccine delivered IM
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites3

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); * Adults of either gender 18-55 years of age at entry; * Healthy subjects as judged by the ...

Countries:United States
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Frequently asked questions about INO-3605

What is INO-3605?

INO-3605 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-3605 has not been publicly disclosed.

Who is developing INO-3605?

INO-3605 is being developed by Inovio Pharmaceuticals, Inc., which trades on the Nasdaq under the ticker symbol INO. The company sponsored the Phase 1 study of the candidate.

What phase is INO-3605 in?

INO-3605 is in Phase 1 development. One Phase 1 trial has been completed, and no active trials are currently listed. It is an investigational product and has not been approved by the FDA.

What clinical trial is INO-3605 in?

INO-3605 was evaluated in the completed Phase 1 trial NCT01405885, titled "A Study of DNA Vaccine With Electroporation for the Prevention of Disease Caused by H1 and H5 Influenza Virus." The study enrolled 116 healthy adult volunteers in the United States and used an active-controlled design.

What was the design of the INO-3605 Phase 1 trial?

The Phase 1 trial NCT01405885 was an active-controlled study that enrolled 116 healthy volunteers aged 18 years and older in the United States. It was not randomized and not double-blinded, and it has been completed.