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INO-4500

Phase 1

Lassa Fever | Small molecule | Other |Inovio Pharmaceuticals, Inc.|Last Updated: Nov 21, 2022

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials2
Total Enrollment280
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04093076Dose-ranging Study: Safety, Tolerability and Immunogenicity of INO-4500 in Healthy Volunteers in GhanaPHASE1 COMPLETED 220 — — Jan 27, 2021Oct 14, 2022Nov 21, 20221 Ghana
NCT03805984Safety, Tolerability and Immunogenicity of INO-4500 in Healthy VolunteersPHASE1 COMPLETED 60 — — May 9, 2019Oct 21, 2020Nov 23, 20201 United States
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Study Endpoints
Primary Endpoints
Number of Participants with Adverse Events (AEs)
Baseline up to Week 48
Number of Participants with Injection Site Reactions
Day 0 up to Week 48
Number of Participants with Adverse Events of Special Interest (AESIs)
Baseline up to Week 48
Change from Baseline in Lassa Virus (LASV) Antigen Specific Binding Antibodies
Day 0 up to Week 48
Change from Baseline in Lassa virus (LASV) Neutralization Assays
Day 0 up to Week 48
Change from Baseline in Interferon-Gamma Response Magnitude
Day 0 up to Week 48
Percentage of Participants with Adverse Events (AEs)
Baseline up to Week 48
Percentage of Participants with Injection Site Reactions
Day 0 up to Week 48
Incidence of adverse events of special interest
Baseline up to Week 48
Secondary Endpoints
Change from Baseline in Antigen Specific Binding Antibody titers
Day 0 up to Week 48
Change from Baseline in Lassa virus (LASV) Neutralizing Antibodies
Day 0 up to Week 48
Change from Baseline in Interferon-Gamma Response Magnitude
Day 0 up to Week 48
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
INO-4500 Group AEXPERIMENTALParticipants will receive 1 ID injection of 1 mg/dose INO-4500 followed by EP using the CELLECTRA™ 2000 device.
INO-4500 Group BEXPERIMENTALParticipants will receive 2 ID injections of 1 mg/dose INO-4500 followed by EP using the CELLECTRA™ 2000 device in two acceptable locations in two different limbs at each dosing visit.
Placebo Group CPLACEBO_COMPARATORParticipants will receive 1 ID injection of 1 mg/dose placebo followed by EP using the CELLECTRA™ 2000 device.
Placebo Group DPLACEBO_COMPARATORParticipants will receive 2 ID injections of 1 mg/dose placebo followed by EP using the CELLECTRA™ 2000 device in two acceptable locations in two different limbs at each dosing visit..
Placebo Comparator Group APLACEBO_COMPARATORParticipants will receive 1 ID injection of 1 mg/dose placebo followed by EP using the CELLECTRA® 2000 device
Placebo Comparator Group BPLACEBO_COMPARATORParticipants will receive 2 ID injections of 1 mg/dose placebo followed by EP using the CELLECTRA® 2000 device
Interventions
NameTypeDescription
INO-4500DRUGINO-4500 will be administered ID on Day 0 and Week 4.
CELLECTRA™ 2000DEVICEEP using the CELLECTRA™ 2000 device will be administered following ID drug administration.
PlaceboDRUGPlacebo will be administered ID on Day 0 and Week 4.
CELLECTRA® 2000DEVICEEP using the CELLECTRA® 2000 device will be administered following ID drug administration.
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Eligibility Criteria
Age Range18 Years — 50 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Judged to be healthy by the Investigator on the basis of medical history, physical examination and vital signs performed at Screening; * Negative tests for Hepatitis B surface antigen (HBsAg), Hepatitis C antibody and Human Immunodeficiency Virus (HIV) antibody; * Screening el...

Countries:GhanaUnited States
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