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Safety, Tolerability and Immunogenicity of INO-4500 in Healthy Volunteers

NCT03805984 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2020-11-23

No results posted yet for this study

Summary

This is a randomized and double-blinded within study group, placebo-controlled trial to evaluate the safety, tolerability and immunological profile of INO-4500 administered by intradermal (ID) injection followed by electroporation using the CELLECTRA® 2000 device in healthy adult volunteers.

Conditions

  • Lassa Fever

Interventions

DRUG

INO-4500

INO-4500 will be administered ID on Day 0 and Week 4.

DRUG

Placebo

Placebo will be administered ID on Day 0 and Week 4.

DEVICE

CELLECTRA® 2000

EP using the CELLECTRA® 2000 device will be administered following ID drug administration.

Sponsors & Collaborators

Principal Investigators

  • Mammen Mammen, MD, FACP, FIDSA · Inovio Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-05-09
Primary Completion
2020-10-21
Completion
2020-10-21
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03805984 on ClinicalTrials.gov