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A Single and Multiple Ascending Dose Study of JNJ-64457744 | Clinical Trials | Clareo Health

TERMINATEDPHASE1

A Single and Multiple Ascending Dose Study of JNJ-64457744

A Phase 1, Blinded, Randomized, Placebo-controlled, First-in-human Study of Orally Administered JNJ-64457744 to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics After Single and Multiple Ascending Doses

NCT05423106•Janssen Research & Development, LLC

View on ClinicalTrials.gov

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).

Eligibility

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Normal left ventricular heart function as defined as left ventricular ejection fraction (LVEF) greater than or equal to (\>=) 5 percent (%), as assessed by 2 dimension electrocardiogram (2DECHO) at screening
•All women must have a negative urine pregnancy test at screening and Day -1 (of each intervention period, if applicable)
•A woman must not be of childbearing potential
•Part 1 and 3: Must have an estimated creatinine clearance greater than (\>) 80 milliliter (mL) per minute at screening, calculated by the modification of diet in renal disease (MDRD) formula
•Part 2: Must have chronic HBV infection. HBV infection must be documented by serum HBsAg positivity at screening
•Must be fully vaccinated against coronavirus disease 2019 (COVID-19) at least 2 weeks prior to screening calculated by the modification of diet in renal disease (MDRD) formula
•Participants in Cohorts A-I and K in Part 1 must not have maternal and paternal parents and/or grandparents of Asian ethnicity (that is, China, Japan, Korea as confirmed by interview) Participants in Cohort J must have maternal and paternal parents and grandparents of Asian ethnicity (that is, China, Japan, Korea as confirmed by interview)

Exclusion Criteria

•History of cardiac arrhythmias (example, extrasystole, tachycardia at rest), history of risk factors for Torsades de Pointes syndrome (example, hypokalemia, family history of long QT syndrome) or history or other clinical evidence of significant or unstable cardiac disease (example, angina, congestive heart failure, myocardial infarction, diastolic dysfunction, significant arrhythmia, coronary heart disease, and/or clinically significant electrocardiogram (\[ECG\] abnormalities), moderate to severe valvular disease or uncontrolled hypertension at screening. Any evidence of second and third degree heart block or right bundle branch block is also exclusionary
•Participants with abnormal sinus rhythm (heart rate less than \[\<\] 45 or \> 100 beats per minute \[bpm\]), QT corrected for heart rate according to Fridericia's formula (QTcF) \> 450 milliseconds (ms) for male participants and \> 470 ms for female participants, QRS \>= 120 ms, PR interval \>220 ms, abnormal conduction, or any other clinically significant abnormalities on a 12-lead ECG at screening
•Family history of inherited mitochondrial disorders such as inherited mitochondrial myopathy, mitochondrial encephalomyopathy with lactic acidosis and stroke-like episodes (MELAS) syndrome
•Known allergies, hypersensitivity, or intolerance to JNJ-64457744 or its excipients
•History of clinically significant drug allergy such as, but not limited to, sulfonamides and penicillins, or drug allergy witnessed in previous studies with experimental drugs

Locations (1)

New Zealand Clinical Research

Grafton, New Zealand

Key Dates

Start Date

July 4, 2022

Primary Completion Date

March 14, 2023

Completion Date

March 20, 2023

Last Updated

February 3, 2025

Enrollment

ACTUAL participants

Conditions

HealthyHepatitis B, Chronic

Interventions

JNJ-64457744

DRUG

Placebo

DRUG

Tenofovir Disoproxil Fumarate (TDF)

DRUG

Tenofovir Alafenamide (TAF)

DRUG

Entecavir (ETV)

DRUG

JNJ-64457744

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 3, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Single and Multiple Ascending Dose Study of JNJ-64457744

Inclusion Criteria

Exclusion Criteria

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