Clinical trial NCT03689153: A Study of JNJ-63733657 in Healthy Japanese Participants
Official title: A Randomized, Placebo-controlled, Double-blind, Single Ascending Dose Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-63733657 in Healthy Japanese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Janssen Pharmaceutical K.K.
Sponsor class: INDUSTRY
First posted: 2018-09-28
Enrollment: 24
Sex: ALL
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety and tolerability of JNJ-63733657 following single ascending intravenous (IV) dose administration in healthy Japanese participants.


Eligibility criteria: Inclusion Criteria:

* Body mass index (BMI; weight \[kilogram {kg}\]/height \[meter square {m\^2}\]) between 18 and 35 kilogram per meter square (kg/m\^2), inclusive, and a body weight greater than 50 kg but less than 110 kg at screening and Day -1. For participants to be enrolled in the highest dose cohort (Cohort 3), additional weight limitations will apply in order not to exceed the total dose of 5 gram (g) JNJ-63733657; the participant weight in the highest dose cohort will be limited
* Women must not be of childbearing potential

Exclusion Criteria:

* History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, hepatic or renal insufficiency, thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
* Clinically significant abnormal values for hematology, clinical chemistry, coagulation, or urinalysis at screening and Day -1 in the opinion of the investigator
* Clinically significant abnormal physical or neurologic examination (including fundoscopy), vital signs, or 12-lead electrocardiogram (ECG) at screening and Day -1 in the opinion of the investigator
* Positive result on hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), hepatitis C virus (HCV) antibody (antiHCV) positive, or any other clinically active liver disease at screening (per screening evaluations)
* History of human immunodeficiency virus (HIV) antibody positive, tests positive for HIV or tests positive for syphilis at screening
* Mini-Mental State Examination (MMSE) score less than or equal to (\<=) 27 at screening

Primary outcomes:
measure: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
timeFrame: Approximately 23 weeks
Secondary outcomes:
measure: Maximum Observed Serum Concentration (Cmax) of JNJ-63733657
timeFrame: Up to Day 106
measure: Time to Reach Maximum Observed Serum Concentration (Tmax) of JNJ-63733657
timeFrame: Up to Day 106
measure: Area Under the Serum Concentration-Time Curve from Time Zero to Time to 56 Days (AUC [0-56days])
timeFrame: 0 hours (Day 1) up to 56 days
measure: Area Under the Serum Concentration-Time Curve from Time Zero to the Time Corresponding to Last Quantifiable Serum Concentration (AUC [0-last])
timeFrame: Up to Day 106
measure: Area Under the Serum Concentration-Time Curve from Time Zero to Infinite Time (AUC [0-infinity])
timeFrame: Up to Day 106
measure: Elimination Rate Constant (Lambda[z]) of JNJ-63733657 in Serum
timeFrame: Up to Day 106
measure: Apparent Elimination Half-Life (t1/2) of JNJ-63733657 in Serum
timeFrame: Up to Day 106
measure: Total Systemic Clearance (CL) of JNJ-63733657 in Serum
timeFrame: Up to Day 106
measure: Volume of Distribution (Vz) of JNJ-63733657 in Serum
timeFrame: Up to Day 106
measure: JNJ-63733657 Concentration in Cerebrospinal Fluid (CSF)
timeFrame: Up to Day 92
measure: Number of Participants with Anti-JNJ-63733657 Antibodies
timeFrame: Up to Day 106
measure: Percentage Change from Baseline in Total, Free, and Bound tau Biomarker Fragments in CSF
timeFrame: Up to Day 92
Other outcomes:
Locations:
city: Fukuoka-shi
country: Japan
facility: Souseikai Fukuoka Mirai Hospital
Study officials:
affiliation: Janssen Pharmaceutical K.K.
name: Janssen Pharmaceutical K.K., Japan Clinical Trial
role: STUDY_DIRECTOR
References: