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A Single and Multiple Ascending Dose Study of JNJ-64457744

NCT05423106 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-02-03

No results posted yet for this study

Summary

The purpose of the study is to evaluate the safety and tolerability of: single ascending dose (SAD) and multiple ascending dose (MAD) administration of JNJ-64457744, administered to healthy adult participants (Part 1 and Part 3), including a cohort of Asian participants (Part 1); and after single dose administration of JNJ-64457744 to chronic hepatitis B (CHB) participants who are virologically suppressed on nucleos(t)ide analog (NA) treatment (tenofovir disoproxil fumarate \[TDF\], tenofovir alafenamide \[TAF\], or entecavir \[ETV\]) (Part 2).

Conditions

  • Healthy
  • Hepatitis B, Chronic

Interventions

DRUG

JNJ-64457744

JNJ-64457744 will be administered as oral solution.

DRUG

Placebo

Placebo will be administered as an oral formulation.

DRUG

Tenofovir Disoproxil Fumarate (TDF)

TDF tablet will be administered orally

DRUG

Tenofovir Alafenamide (TAF)

TAF tablet will be administered orally.

DRUG

Entecavir (ETV)

ETV tablet will be administered orally.

DRUG

JNJ-64457744

JNJ-64457744 will be administered as oral tablet.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research and Development, LLC Clinical Trial · Janssen Research and Development LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2022-07-04
Primary Completion
2023-03-14
Completion
2023-03-20

Countries

  • New Zealand

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 NCT05423106 on ClinicalTrials.gov