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A First-In-Human Study to Evaluate Safety, Tolerability, Reactogenicity, and Immunogenicity of JNJ-64300535, a DNA Vaccine, Administered by Electroporation-Mediated Intramuscular Injection, in Participants With Chronic Hepatitis B Who Are on Stable Nucleos(t)Ide Therapy and Virologically Suppressed

NCT03463369 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-04-14

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety, tolerability, and reactogenicity of escalating doses of JNJ-64300535 delivered via electroporation-mediated intramuscular injection in nucleos(t)ide analogs (NA)-treated chronic hepatitis B (CHB) participants.

Conditions

  • Hepatitis B, Chronic

Interventions

BIOLOGICAL

JNJ-64300535

Participants will receive JNJ-64300535 vaccine by electroporation-mediated IM injection on Day 1, Week 4, and Week 12.

BIOLOGICAL

Placebo

Participants will receive 1 mL (0.9 percent \[%\] sodium chloride \[NaCl\]) of placebo solution matching to JNJ-64300535 electroporation-mediated IM injection on Day 1, Week 4, and Week 12.

DRUG

Nucleos(t)ide Analogs (NA)

Participants will receive NA as a standard of care treatment.

Sponsors & Collaborators

  • Janssen Sciences Ireland UC

    lead INDUSTRY

Principal Investigators

  • Janssen Sciences Ireland UC Clinical Trial · Janssen Sciences Ireland UC

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-18
Primary Completion
2021-03-23
Completion
2021-03-23

Countries

  • Belgium
  • Germany
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

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 NCT03463369 on ClinicalTrials.gov