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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
JNJ-64457744 will be administered as oral solution.
Placebo will be administered as an oral formulation.
TDF tablet will be administered orally
New Zealand Clinical Research
Grafton, New Zealand
Part 1, 2 and 3: Number of Participants With Serious Adverse Events (SAEs)
SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; suspected transmission of any infectious agent via medicinal product; or any important medical events.
Time frame: Up to Week 8
Part 1, 2 and 3: Number of Participants With SAEs by Severity
SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; suspected transmission of any infectious agent via medicinal product; or any important medical events. Severity will be graded according to the Division of Division of Acquired Immunodeficiency Syndrome (DAIDS) grading table where Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Potentially Life-threatening.
Time frame: Up to Week 8
Part 1, 2 and 3: Number of Participants With Clinical Laboratory Abnormalities
Number of participants with clinical laboratory abnormalities (including hematology, biochemistry, coagulation, urinalysis) will be reported.
Time frame: Up to 8 weeks
Part 1, 2 and 3: Number of Participants With Clinical Laboratory Abnormalities by Severity
Number of participants with clinical laboratory abnormalities (including hematology, biochemistry, coagulation, urinalysis) will be reported. Severity will be graded according to the Division of AIDS (DAIDS) grading table where Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Potentially Life-threatening.
Time frame: Up to 8 weeks
Part 1, 2 and 3: Number of Participants With Electrocardiograms (ECGs), Echocardiography, Vital Signs and Physical Examination Abnormalities
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TAF tablet will be administered orally.
ETV tablet will be administered orally.
JNJ-64457744 will be administered as oral tablet.
Number of participants with abnormalities in ECGs, echocardiography, vital signs and physical examination will be reported.
Time frame: Up to Week 8
Part 1, 2 and 3: Number of Participants With Electrocardiograms (ECGs), Echocardiography, Vital Signs and Physical Examination Abnormalities by Severity
Number of participants with abnormalities in ECGs, echocardiography, vital signs and physical examination will be reported. Severity will be graded according to the Division of AIDS (DAIDS) grading table where Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Potentially Life-threatening.
Time frame: Up to 8 weeks
Part 1, 2 and 3: Plasma concentration of JNJ-64457744
Plasma concentration of JNJ-64457744 will be reported.
Time frame: Up to Week 8
Part 1: Plasma Concentration of JNJ-64457744: Within-Participant Analysis
Plasma concentration of JNJ-64457744 assessed within-participant after administration of 3 different single doses under fasted conditions will be reported.
Time frame: Up to 5 weeks
Part 1: Plasma Concentration of JNJ-64457744 Under Fed and Fasted Condition
Plasma Concentration of JNJ-64457744 under fed and fasted conditions will be reported.
Time frame: Up to 5 weeks
Part 1: Plasma Concentration of JNJ-64457744 Under Fasted Condition in Healthy Adult Asian Participants
Plasma concentration of JNJ-64457744 under fasted conditions in healthy adult Asian participants will be reported.
Time frame: Up to 5 weeks
Part 1: Plasma Concentration of JNJ-64457744 Formulation Under Fasted Conditions
Plasma Concentration of JNJ-64457744 formulation as compared with an oral solution formulation under fasted conditions will be reported.
Time frame: Up to 5 weeks