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

NCT ID: NCT03375697

Last Updated: 2025-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-22
• Study Completion Date: 2019-12-16

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 subjects (Part 1) and multiple ascending IV dose administrations in subjects with prodromal or mild Alzheimer's disease (AD) (Part 2).

Conditions

Alzheimer Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

SAD (Part 1): Healthy Subjects

In Part 1, single ascending intravenous (IV) doses of JNJ-63733657 or placebo will be administered to sequential cohorts (Cohorts 1 to 5) of healthy subjects on Day 1. 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. Here, SAD indicates single ascending dose.

Group Type: EXPERIMENTAL

JNJ-63733657

Intervention Type: DRUG

Subjects will receive single (Part 1) or multiple (Part 2) ascending dose levels of JNJ-63733657 intravenously.

Placebo

Intervention Type: DRUG

Subjects will receive matching placebo intravenously.

MAD (Part 2): Subjects With Alzheimer's Disease (AD)

In Part 2, multiple ascending IV doses of JNJ-63733657 or placebo will be evaluated at three dose levels in sequential cohorts in subjects with prodromal or mild AD; 3 doses will be administered over a period of 8 weeks (Day 1, Day 29, Day 57). The starting dose will be decided based on the data from Part 1. Escalations will be done based on safety and tolerability similar to Part 1. Doses will not exceed those tested in Part 1. Here, MAD indicates multiple ascending dose.

Group Type: EXPERIMENTAL

JNJ-63733657

Intervention Type: DRUG

Subjects will receive single (Part 1) or multiple (Part 2) ascending dose levels of JNJ-63733657 intravenously.

Placebo

Intervention Type: DRUG

Subjects will receive matching placebo intravenously.

Interventions

JNJ-63733657

Subjects will receive single (Part 1) or multiple (Part 2) ascending dose levels of JNJ-63733657 intravenously.

Intervention Type: DRUG

Placebo

Subjects will receive matching placebo intravenously.

Intervention Type: DRUG

Eligibility Criteria

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

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

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)

• 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)

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Clinical Pharmacology Unit

Merksem, , Belgium

Klinik für Neurodegenerative Erkrankungen und Gerontopsychiatrie

Bonn, , Germany

CTC North GmbH & Co. KG

Hamburg, , Germany

Universitätsklinikum des Saarlandes

Homburg / Saar, , Germany

Centre for Human Drug Research

Leiden, , Netherlands

Hosp. Clinico San Carlos

Madrid, , Spain

Hosp. Univ. I Politecni La Fe

Valencia, , Spain

Countries

Belgium; Germany; Netherlands; Spain

Other Identifiers

63733657EDI1001

Identifier Type: OTHER

Identifier Source: secondary_id

2017-003852-21

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CR108392

Identifier Type: -

Identifier Source: org_study_id