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INO-4500

Phase 1

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

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment280

FDA Designations

No designations recorded

Clinical trial landscape

INO-4500 · 2 trials · 1 indication

Phase 1 2
NCT04093076Dose-ranging Study: Safety, Tolerability and Immunogenicity of INO-4500 in Healthy Volunteers in GhanaLassa Fever
COMPLETED220 Analytics
NCT03805984Safety, Tolerability and Immunogenicity of INO-4500 in Healthy VolunteersLassa Fever
COMPLETED60 Analytics
PHASE1COMPLETED
Dose-ranging Study: Safety, Tolerability and Immunogenicity of INO-4500 in Healthy Volunteers in Ghana
Lassa FeverUnlock trial analytics
PHASE1COMPLETED
Safety, Tolerability and Immunogenicity of INO-4500 in Healthy Volunteers
Lassa FeverUnlock trial analytics

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 to 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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Frequently asked questions about INO-4500

What is INO-4500 used for?

INO-4500 is an investigational drug being developed for the prevention of Lassa Fever, an infectious disease. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being studied in healthy volunteers to assess its safety, tolerability, and immunogenicity.

Who makes INO-4500?

INO-4500 is being developed by Inovio Pharmaceuticals, Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol INO. The company is conducting clinical trials to evaluate the drug's potential as a preventive measure against Lassa Fever.

What phase is INO-4500 in?

INO-4500 is in Phase 1 clinical development. It is an investigational drug and has not yet received approval from regulatory agencies. The Phase 1 trials have been completed, and the drug is not currently in active clinical trials, as per the latest available data.

What clinical trials is INO-4500 in?

INO-4500 has been studied in two completed Phase 1 clinical trials. The first trial, NCT03805984, enrolled 60 healthy volunteers in the United States. The second trial, NCT04093076, enrolled 220 healthy volunteers in Ghana. Both trials were randomized, double-blind, and placebo-controlled, focusing on safety, tolerability, and immunogenicity.

How does INO-4500 work?

INO-4500 is a small molecule drug designed to target Lassa Fever. The specific molecular target or mechanism of action has not been disclosed in the available information. The drug is being evaluated for its ability to generate an immune response against the Lassa virus in healthy individuals.