CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 30 enrolled
Drug / intervention
JNJ-64300535 +2 morebiological
Likely dose
Placebo 1 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03463369
NCT03463369Phase 1Completed
CompareCT.gov

A First-In-Human, Double-Blind, Randomized, Placebo-Controlled, Phase 1 Study to Evaluate the 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

Janssen Sciences Ireland UC·interventional·Posted Mar 13, 2018·Updated Apr 14, 2021

In Brief

A Phase 1 clinical trial evaluating JNJ-64300535, Placebo, and 1 other intervention for Hepatitis B, Chronic. Completed, enrolled 30 participants across 14 sites in 3 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis B, Chronic
CountriesBelgium, Germany, United Kingdom
Collaborators--

Timeline

Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedMar 13, 2018
Enrollment StartApr 18, 2018
Primary CompletionMar 23, 2021
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 8.3 years ago

Interventions

JNJ-64300535biological

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

Placebobiological

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.

Nucleos(t)ide Analogs (NA)drug

Participants will receive NA as a standard of care treatment.