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

Janssen Research & Development, LLC48 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Healthy

Interventions

JNJ-64232025 IVDRUG

JNJ-64232025 will be administered as IV infusion.

JNJ-64232025 SCDRUG

JNJ-64232025 will be administered as SC injection.

PlaceboDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

SGS Life Science Services

Antwerp, Belgium

Outcomes

Primary Outcomes

Number of Participants with Treatment-Emergent Adverse Events (TEAE) by Severity

An adverse event (AE) is any untoward medical occurrence in a participant who receive study drug without regard to possibility of causal relationship. The severity of the TEAEs will be assessed as mild, moderate, or severe.

Time frame: Up to Day 113

Number of Participants with Serious Adverse Events (SAE)

An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

Time frame: Up to Day 113

Number of Participants with Clinically Significant Changes in Vital Signs

Number of participants with clinically significant changes in the vital signs including temperature, pulse/heart rate, respiratory rate, and blood pressure will be reported.

Time frame: Up to Day 113

Number of Participants with ECG Abnormalities

Number of participants with electrocardiogram (ECG) abnormalities will be reported.

Time frame: Up to Day 113

Number of Participants with Clinical Laboratory Abnormalities

Number of participants with clinical laboratory abnormalities, including cytomegalovirus (CMV) and Epstein-Barr virus (EBV) viral loads, will be reported.

Time frame: Up to Day 113

Secondary Outcomes

Maximum Observed Plasma Concentration (Cmax) of JNJ-64232025

The Cmax is the maximum observed plasma concentration of JNJ-64232025.

Time frame: Up to Day 113

Data from ClinicalTrials.gov

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