A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JNJ-64232025 in Healthy Participants

NCT ID: NCT03550950

Last Updated: 2025-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-01
• Study Completion Date: 2019-02-05

Brief Summary

The purpose of this study is to assess the safety and tolerability of JNJ-64232025 following single ascending intravenous (IV) study intervention administrations and a single subcutaneous (SC) intervention administration in healthy participants.

Conditions

Healthy

Study Design

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

Study Groups

Single Ascending Dose (SAD) IV Cohort

Participants will receive single intravenous (IV) dose of JNJ-64232025 or placebo in Cohorts 1 to 6 on Day 1.

Group Type: EXPERIMENTAL

JNJ-64232025 IV

Intervention Type: DRUG

JNJ-64232025 will be administered as IV infusion.

Placebo

Intervention Type: DRUG

Matching placebo will be administered as IV infusion or SC injection.

Subcutaneous (SC) Cohort

Participants will receive single dose of JNJ-64232025 or placebo as SC injection.

Group Type: EXPERIMENTAL

JNJ-64232025 SC

Intervention Type: DRUG

JNJ-64232025 will be administered as SC injection.

Placebo

Intervention Type: DRUG

Matching placebo will be administered as IV infusion or SC injection.

Interventions

JNJ-64232025 IV

JNJ-64232025 will be administered as IV infusion.

Intervention Type: DRUG

JNJ-64232025 SC

JNJ-64232025 will be administered as SC injection.

Intervention Type: DRUG

Placebo

Matching placebo will be administered as IV infusion or SC injection.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Male or female of non-childbearing potential (postmenopausal or permanently sterile)
• Have a body mass index (BMI) between 19 and 30 kilogram per meter square (kg/m^2) (BMI = weight/height^2), and a body weight of 50 to 100 kilogram (kg), inclusive
• Healthy on the basis of medical history, a physical examination, vital signs, and 12 lead electrocardiogram (ECG) performed at screening
• Healthy on the basis of clinical laboratory tests performed at screening and Day -1
• A woman must have a negative highly sensitive serum pregnancy test at screening and a negative urine pregnancy test on Day -1

Exclusion Criteria

• Has history of any clinically significant medical illness or medical disorders the investigator considers should exclude the participant, including (but not limited to), neuromuscular, hematological disease, immune deficiency state, respiratory disease, hepatic or gastrointestinal disease, neurological or psychiatric disease, ophthalmological disorders, neoplastic disease, renal or urinary tract diseases, or dermatological disease
• Has a disease or disease treatment associated with immune suppression or lymphopenia, these include but are not limited to bone marrow or organ transplantation, lymphoproliferative disorders, T- or B-cell deficiency syndromes, splenectomy, functional asplenism, and chronic granulomatous disease
• Has a personal history of or conditions associated with thromboembolic events or bleeding disorders, including (but not limited to) myocardial infarction (MI), cerebral vascular accident (CVA)/stroke, deep vein thrombosis (DVT), pulmonary embolism (PE), hemophilia, or menometrorrhagia
• Has history of allergy or adverse reactions to shellfish, aluminum, aluminum hydroxide keyhole limpet hemocyanin (KLH), tetanus or tetanus toxoid or its excipients
• Has a known or suspected intolerance or hypersensitivity to any biologic medication or known allergies or clinically significant reactions to murine, chimeric, or human proteins, monoclonal antibodies or antibody fragments, or to any components of the formulation of JNJ-64232025 and its excipients used in this study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 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

SGS Life Science Services

Antwerp, , Belgium

Countries

Belgium

Other Identifiers

2017-003986-82

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

64232025ARA1001

Identifier Type: OTHER

Identifier Source: secondary_id

CR108448

Identifier Type: -

Identifier Source: org_study_id