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HealthyPhase 1NCT03689153

A Study of JNJ-63733657 in Healthy Japanese Participants

A Phase 1 study testing JNJ-63733657 in people with Healthy, run by Janssen Pharmaceutical K.K. at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 55 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
JNJ-63733657
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
24 participants
Where
1 siteJapan
Study dates
28 Sep 2018to 11 Jul 2019
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Japan1 site

  • Souseikai Fukuoka Mirai Hospital

    Fukuoka, 813-0017

Other trials in Japan

About this study

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

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.

Conditions
Healthy
Being tested
JNJ-63733657, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JNJ-63733657Drug

    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.

  • PlaceboDrug

    Participants will receive matching placebo intravenously.

Study groups in NCT03689153
Study groupRoleWhat they receive
Cohort 1: JNJ-63733657 or PlaceboExperimentalParticipants will receive a single intravenous (IV) low dose of JNJ-63733657 or matching placebo.
Receives: Drug: JNJ-63733657; Drug: Placebo
Cohort 2: JNJ-63733657 or PlaceboExperimentalParticipants will receive a single IV middle dose of JNJ-63733657 or matching placebo.
Receives: Drug: JNJ-63733657; Drug: Placebo
Cohort 3: JNJ-63733657 or PlaceboExperimentalParticipants will receive a single IV high dose of JNJ-63733657 or matching placebo.
Receives: Drug: JNJ-63733657; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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.

    Measured: Approximately 23 weeks

Secondary outcomes (12)

  1. Maximum Observed Serum Concentration (Cmax) of JNJ-63733657

    The Cmax is the maximum observed serum concentration.

    Measured: Up to Day 106

  2. Time to Reach Maximum Observed Serum Concentration (Tmax) of JNJ-63733657

    The Tmax is defined as actual sampling time to reach maximum observed serum concentration.

    Measured: Up to Day 106

  3. Area Under the Serum Concentration-Time Curve from Time Zero to Time to 56 Days (AUC [0-56days])

    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.

    Measured: 0 hours (Day 1) up to 56 days

  4. Area Under the Serum Concentration-Time Curve from Time Zero to the Time Corresponding to Last Quantifiable Serum Concentration (AUC [0-last])

    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.

    Measured: Up to Day 106

  5. Area Under the Serum Concentration-Time Curve from Time Zero to Infinite Time (AUC [0-infinity])

    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.

    Measured: Up to Day 106

  6. Elimination Rate Constant (Lambda[z]) of JNJ-63733657 in Serum

    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.

    Measured: Up to Day 106

  7. Apparent Elimination Half-Life (t1/2) of JNJ-63733657 in Serum

    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).

    Measured: Up to Day 106

  8. Total Systemic Clearance (CL) of JNJ-63733657 in Serum

    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]).

    Measured: Up to Day 106

  9. Volume of Distribution (Vz) of JNJ-63733657 in Serum

    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.

    Measured: Up to Day 106

  10. JNJ-63733657 Concentration in Cerebrospinal Fluid (CSF)

    CSF concentration assessments will be done for JNJ-63733657.

    Measured: Up to Day 92

  11. Number of Participants with Anti-JNJ-63733657 Antibodies

    Number of participants with anti-JNJ-63733657 antibodies will be determined in serum samples.

    Measured: Up to Day 106

  12. Percentage Change from Baseline in Total, Free, and Bound tau Biomarker Fragments in CSF

    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.

    Measured: Up to Day 92

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Sep 2018
  2. Study start28 Sep 2018
  3. Primary completion11 Jul 2019
  4. Study completion11 Jul 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03689153
Sponsor's protocol ID
CR108522
Other IDs
63733657EDI1002
Status last verified
Apr 2025
First submitted
27 Sep 2018
Last updated
28 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Galpern WR, Triana-Baltzer G, Li L, Van Kolen K, Timmers M, Haeverans K, Janssens L, Kolb H, Nandy P, Aida K, Shimizu H, Mercken M, Sun H. Phase 1 Studies of the Anti-Tau Monoclonal Antibody JNJ-63733657 in Healthy Participants and Participants with Alzheimer's Disease. J Prev Alzheimers Dis. 2024;11(6):1592-1603. doi: 10.14283/jpad.2024.163.

    PubMed 39559872

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing JNJ-63733657 in people with Healthy, run by Janssen Pharmaceutical K.K. at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability (time frame: Approximately 23 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03689153, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2025.

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