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A Study of INO-A002 in Healthy Dengue Virus-naive Adults

NCT03831503 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-12-14

No results posted yet for this study

Summary

Phase 1, open label, single center, dose escalation study to evaluate the safety, tolerability and pharmacokinetic profile of dMAb-ZK190 following delivery of INO-A002 with Hylenex® recombinant delivered IM followed by EP in healthy adult Dengue naïve volunteers ages 18-60 years.

Conditions

  • Healthy Volunteers

Interventions

BIOLOGICAL

INO-A002

Participants will receive one or two 1 ml IM injections (in different arms) into the deltoid region at day 0 (all groups), and in addition on day 3 (in the 2 mg and 4 mg cohorts).

DEVICE

CELLECTRA® 2000

Inoculation will be followed by electroporation with the CELLECTRA® 2000 device.

DEVICE

Dengue Fever Antibodies (IgG)

To determine if the subject is Dengue seronegative at baseline

Sponsors & Collaborators

Principal Investigators

  • Pablo Tebas, MD · University of Pennsylvania

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2019-02-07
Primary Completion
2022-10-03
Completion
2022-10-03
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

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 NCT03831503 on ClinicalTrials.gov