CompletedPhase 1

A Study to Investigate Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-63733657 in Healthy Subjects and Subjects With Alzheimer's Disease

A 2-Part Randomized, Placebo-Controlled, Double-Blind, Single and Multiple Ascending Dose Study to Investigate Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-63733657 in Healthy Subjects and Subjects With Alzheimer's Disease

Lead sponsor

Janssen Research & Development, LLC

Asset

JNJ-63733657

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Age 55-75

Primary endpoints

•Single Ascending Dose (SAD) (Part 1)•Multiple Ascending Dose (MAD) (Part 2)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Eudract number2017-003852-21

Secondary ID63733657EDI1001Janssen Research & Development, LLC

Org study IDCR108392

NCT IDNCT03375697

Timeline

Milestones

Study first posted2017-12-18actual

Study start2017-12-22actual

Primary completion2019-12-16actual

Study completion2019-12-16actual

Last update posted2025-04-27actual

Assets

Drug assets

JNJ-63733657

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age55 Years

Maximum age75 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

General Inclusion Criteria:

•Body mass index (BMI) between 18 and 35 kilogram per meter square (kg/m^2), inclusive (BMI = weight/height^2) and body weight greater than 40 kilogram (kg) but less than 110 kg at screening

•Women must not be of childbearing potential

Specific Inclusion Criteria Part 2:

Each potential subject enrolled in Part 2 must satisfy all of the following specific criteria in addition to the general criteria to be enrolled in the study:

•Clinical Dementia Rating Scale (CDR) global rating score of 0.5 or 1.0 at screening

•Must have a reliable informant (example, relative, partner, friend)

•Must have cerebrospinal fluid (CSF) finding consistent with Alzheimer's disease (AD) pathology

Exclusion criteria

General Exclusion Criteria

Any potential subject who meets any of the following criteria will be excluded from participating in the study:

•History of or current liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic (including but not limited to neurodegenerative disease (excluding AD for Part 2) [example, Parkinson's disease], seizure disorders, transient ischemic attacks, etc.), hematologic (including coagulation disorders), rheumatologic, psychiatric, or metabolic disturbances, any inflammatory illness or any other illness that the Investigator considers should exclude the subject

•Relevant history of or current neurological disease (other than prodromal AD or mild AD for Part 2), which in the opinion of the investigator may make interpretation of possible new neurological signs or symptoms difficult

•History of human immunodeficiency virus (HIV) antibody positive, or tests positive for HIV at Screening (per screening evaluations)

•History of hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-Hepatitis C virus [HCV]) positive, or other clinically active liver disease, or tests positive for HBsAg or anti-HCV at screening (per screening evaluations)

Specific Exclusion Criteria Part 1 - Mini-Mental State Examination (MMSE) score less than or equal to (<=) 27 at screening

Specific Exclusion Criteria Part 2

- Evidence of brain disease, other than AD, that could explain the cognitive deficit (including, but not limited to, vascular encephalopathy or strokes, as imaged by cerebral Magnetic resonance imaging (MRI)

Endpoints (14)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK

Fluid / digital biomarkers

3 endpoints

Secondary/protocol endpoint

SAD (Part 1) and MAD (Part 2): JNJ-63733657 Concentration in Cerebrospinal Fluid (CSF)

Time frame:Up to Day 57 (SAD) and up to Day 148 (MAD)

concentration, descriptive

Secondary/protocol endpoint

SAD (Part 1) and MAD (Part 2): Number of Subjects With Anti-JNJ-6373365 Antibodies as a Measure of Immunogenicity

Time frame:Up to Day 106 (SAD) and up to Day 162 (MAD)

event count, event

Secondary/protocol endpoint

SAD (Part 1) and MAD (Part 2): Percent Change From Baseline in Total, Free, and Bound tau Biomarker Fragments in CSF

Time frame:Up to Day 106 (SAD) and up to Day 162 (MAD)

percent change from baseline, improvement

Safety / tolerability / PK

11 endpoints

Primary/protocol endpoint

Single Ascending Dose (SAD) (Part 1): Number of Subjects With Adverse Events as a Measure of Safety and Tolerability of JNJ-63733657

Time frame:Up to Day 106

event count, event

Primary/protocol endpoint

Multiple Ascending Dose (MAD) (Part 2): Number of Subjects With Adverse Events as a Measure of Safety and Tolerability of JNJ-63733657

Time frame:Up to Day 162

event count, event

Secondary/protocol endpoint

SAD (Part 1) and MAD (Part 2): Maximum Observed Serum Concentration (Cmax) of JNJ-63733657

Time frame:Up to Day 106 (SAD) and up to Day 162 (MAD)

concentration, descriptive

Secondary/protocol endpoint

SAD (Part 1) and MAD (Part 2): Time to Reach Maximum Observed Serum Concentration (Tmax) of JNJ-63733657

Time frame:Up to Day 106 (SAD) and up to Day 162 (MAD)

time to event, event

Secondary/protocol endpoint

SAD (Part 1) and MAD (Part 2): Area Under the Serum Concentration-time Curve From Time Zero to Time of the Last Observed Quantifiable Concentration (AUC [0-Last]) of JNJ-63733657

Time frame:Up to Day 106 (SAD) and up to Day 162 (MAD)

concentration, descriptive

Secondary/protocol endpoint

SAD (Part 1) and MAD (Part 2): Area Under the Serum Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) of JNJ-63733657

Time frame:Up to Day 106 (SAD) and up to Day 162 (MAD)

concentration, descriptive

Secondary/protocol endpoint

MAD (Part 2): Area Under the Serum JNJ-63733657 Concentration-time Curve During a Dosing Interval (t) (AUC tau)

Time frame:Up to Day 85 (MAD)

concentration, descriptive

Secondary/protocol endpoint

MAD (Part 2): Accumulation Ratio (R)

Time frame:Up to Day 162 (MAD)

concentration, descriptive

Secondary/protocol endpoint

SAD (Part 1) and MAD (Part 2): Total Systemic Clearance (CL) of JNJ-63733657

Time frame:Up to Day 106 (SAD) and up to Day 162 (MAD)

concentration, descriptive

Secondary/protocol endpoint

SAD (Part 1) and MAD (Part 2): Volume of Distribution at Steady-State (Vss) of JNJ-63733657

Time frame:Up to Day 106 (SAD) and up to Day 162 (MAD)

concentration, descriptive

Secondary/protocol endpoint

SAD (Part 1) and MAD (Part 2): Terminal Half-Life(t[1/2]) of JNJ-63733657

Time frame:Up to Day 106 (SAD) and up to Day 162 (MAD)

concentration, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.