Clinical Trials/NCT03689153

NCT03689153

Completed

Phase 1

A Randomized, Placebo-controlled, Double-blind, Single Ascending Dose Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-63733657 in Healthy Japanese Subjects

Janssen Pharmaceutical K.K.1 site in 1 country24 target enrollmentSeptember 28, 2018

ConditionsHealthy

InterventionsJNJ-63733657 Placebo

DrugsJNJ-63733657 Placebo

Overview

Phase: Phase 1
Intervention: JNJ-63733657
Conditions: Healthy
Sponsor: Janssen Pharmaceutical K.K.
Enrollment: 24
Locations: 1
Primary Endpoint: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 28, 2018

End Date

July 11, 2019

Last Updated

last year

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Janssen Pharmaceutical K.K.

Responsible Party

Sponsor

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 -
•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

Arms & Interventions

Cohort 1: JNJ-63733657 or Placebo

Participants will receive a single intravenous (IV) low dose of JNJ-63733657 or matching placebo.

Intervention: JNJ-63733657

Cohort 1: JNJ-63733657 or Placebo

Participants will receive a single intravenous (IV) low dose of JNJ-63733657 or matching placebo.

Intervention: Placebo

Cohort 2: JNJ-63733657 or Placebo

Participants will receive a single IV middle dose of JNJ-63733657 or matching placebo.

Intervention: JNJ-63733657

Cohort 2: JNJ-63733657 or Placebo

Participants will receive a single IV middle dose of JNJ-63733657 or matching placebo.

Intervention: Placebo

Cohort 3: JNJ-63733657 or Placebo

Participants will receive a single IV high dose of JNJ-63733657 or matching placebo.

Intervention: JNJ-63733657

Cohort 3: JNJ-63733657 or Placebo

Participants will receive a single IV high dose of JNJ-63733657 or matching placebo.

Intervention: Placebo

Outcomes

Primary Outcomes

Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability

Time Frame: Approximately 23 weeks

An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.

Secondary Outcomes

Area Under the Serum Concentration-Time Curve from Time Zero to the Time Corresponding to Last Quantifiable Serum Concentration (AUC [0-last])(Up to Day 106)
Area Under the Serum Concentration-Time Curve from Time Zero to Infinite Time (AUC [0-infinity])(Up to Day 106)
Elimination Rate Constant (Lambda[z]) of JNJ-63733657 in Serum(Up to Day 106)
Apparent Elimination Half-Life (t1/2) of JNJ-63733657 in Serum(Up to Day 106)
JNJ-63733657 Concentration in Cerebrospinal Fluid (CSF)(Up to Day 92)
Number of Participants with Anti-JNJ-63733657 Antibodies(Up to Day 106)
Percentage Change from Baseline in Total, Free, and Bound tau Biomarker Fragments in CSF(Up to Day 92)
Time to Reach Maximum Observed Serum Concentration (Tmax) of JNJ-63733657(Up to Day 106)
Maximum Observed Serum Concentration (Cmax) of JNJ-63733657(Up to Day 106)
Area Under the Serum Concentration-Time Curve from Time Zero to Time to 56 Days (AUC [0-56days])(0 hours (Day 1) up to 56 days)
Total Systemic Clearance (CL) of JNJ-63733657 in Serum(Up to Day 106)
Volume of Distribution (Vz) of JNJ-63733657 in Serum(Up to Day 106)