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A Study of JNJ-63733657 in Healthy Japanese Participants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03689153
Recruitment Status : Completed
First Posted : September 28, 2018
Last Update Posted : August 21, 2019
Sponsor:
Information provided by (Responsible Party):
Janssen Pharmaceutical K.K.

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: JNJ-63733657 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : September 28, 2018
Actual Primary Completion Date : July 11, 2019
Actual Study Completion Date : July 11, 2019

Arm Intervention/treatment
Experimental: Cohort 1: JNJ-63733657 or Placebo
Participants will receive a single intravenous (IV) low dose of JNJ-63733657 or matching placebo.
Drug: JNJ-63733657
Single ascending IV low, middle, and high dose of JNJ-63733657 will be administered in sequential cohorts. The progression to the next (higher) dose level is dependent on acceptable safety and tolerability profile of JNJ-63733657 obtained after dose administration of the current dose level. The length of time between dosing days of cohorts will be at least 14 days.

Drug: Placebo
Participants will receive matching placebo intravenously.

Experimental: Cohort 2: JNJ-63733657 or Placebo
Participants will receive a single IV middle dose of JNJ-63733657 or matching placebo.
Drug: JNJ-63733657
Single ascending IV low, middle, and high dose of JNJ-63733657 will be administered in sequential cohorts. The progression to the next (higher) dose level is dependent on acceptable safety and tolerability profile of JNJ-63733657 obtained after dose administration of the current dose level. The length of time between dosing days of cohorts will be at least 14 days.

Drug: Placebo
Participants will receive matching placebo intravenously.

Experimental: Cohort 3: JNJ-63733657 or Placebo
Participants will receive a single IV high dose of JNJ-63733657 or matching placebo.
Drug: JNJ-63733657
Single ascending IV low, middle, and high dose of JNJ-63733657 will be administered in sequential cohorts. The progression to the next (higher) dose level is dependent on acceptable safety and tolerability profile of JNJ-63733657 obtained after dose administration of the current dose level. The length of time between dosing days of cohorts will be at least 14 days.

Drug: Placebo
Participants will receive matching placebo intravenously.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Maximum Observed Serum Concentration (Cmax) of JNJ-63733657 [ Time Frame: Up to Day 106 ]
    The Cmax is the maximum observed serum concentration.

  2. Time to Reach Maximum Observed Serum Concentration (Tmax) of JNJ-63733657 [ Time Frame: Up to Day 106 ]
    The Tmax is defined as actual sampling time to reach maximum observed serum concentration.

  3. Area Under the Serum Concentration-Time Curve from Time Zero to Time to 56 Days (AUC [0-56days]) [ Time Frame: 0 hours (Day 1) up to 56 days ]
    The AUC (0-56days) is the area under the serum concentration versus time curve from time 0 to time to 56 days after the start of infusion.

  4. Area Under the Serum Concentration-Time Curve from Time Zero to the Time Corresponding to Last Quantifiable Serum Concentration (AUC [0-last]) [ Time Frame: Up to Day 106 ]
    The AUC (0-last) is the area under the serum concentration-time curve from time zero time to the time corresponding to the last quantifiable serum concentration.

  5. Area Under the Serum Concentration-Time Curve from Time Zero to Infinite Time (AUC [0-infinity]) [ Time Frame: Up to Day 106 ]
    The AUC (0-infinity) is the area under the serum concentration-time curve from time zero to infinite time, calculated as the sum of AUC(0-last) and C(last)/lambda(z); wherein AUC(0-last) is area under the serum concentration-time curve from time zero to last quantifiable time, C(last) is the last observed measurable serum concentration, and lambda(z) is elimination rate constant.

  6. Elimination Rate Constant (Lambda[z]) of JNJ-63733657 in Serum [ Time Frame: Up to Day 106 ]
    Lambda(z) is first-order elimination rate constant associated with the terminal portion of the curve, determined as the negative slope of the terminal log-linear phase of the drug concentration-time curve.

  7. Apparent Elimination Half-Life (t1/2) of JNJ-63733657 in Serum [ Time Frame: Up to Day 106 ]
    The elimination half-life (t1/2) is the time measured for the serum concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z).

  8. Total Systemic Clearance (CL) of JNJ-63733657 in Serum [ Time Frame: Up to Day 106 ]
    Systemic clearance is a quantitative measure of the rate at which a drug substance is removed from the body. The total systemic clearance after intravenous dose was estimated by dividing the total administered dose by the serum area under the plasma concentration-time curve from time zero to infinite time (AUC[0-infinity]).

  9. Volume of Distribution (Vz) of JNJ-63733657 in Serum [ Time Frame: Up to Day 106 ]
    The Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.

  10. JNJ-63733657 Concentration in Cerebrospinal Fluid (CSF) [ Time Frame: Up to Day 92 ]
    CSF concentration assessments will be done for JNJ-63733657.

  11. Number of Participants with Anti-JNJ-63733657 Antibodies [ Time Frame: Up to Day 106 ]
    Number of participants with anti-JNJ-63733657 antibodies will be determined in serum samples.

  12. Percentage Change from Baseline in Total, Free, and Bound tau Biomarker Fragments in CSF [ Time Frame: Up to Day 92 ]
    Percentage change from baseline in total, free, and bound tau (phosphorylation site) biomarker fragments in CSF will be evaluated to assess the effect of JNJ-63733657.



Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03689153


Locations
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Japan
Souseikai Fukuoka Mirai Hospital
Fukuoka, Japan, 813-0017
Sponsors and Collaborators
Janssen Pharmaceutical K.K.
Investigators
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Study Director: Janssen Pharmaceutical K.K., Japan Clinical Trial Janssen Pharmaceutical K.K.
Additional Information:
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Responsible Party: Janssen Pharmaceutical K.K.
ClinicalTrials.gov Identifier: NCT03689153    
Other Study ID Numbers: CR108522
63733657EDI1002 ( Other Identifier: Janssen Pharmaceutical K.K., Japan )
First Posted: September 28, 2018    Key Record Dates
Last Update Posted: August 21, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No