A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JNJ-64232025 in Healthy Participants
Overview
- Phase
- Phase 1
- Intervention
- JNJ-64232025 IV
- Conditions
- Healthy
- Sponsor
- Janssen Research & Development, LLC
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- Number of Participants with Treatment-Emergent Adverse Events (TEAE) by Severity
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
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
Arms & Interventions
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.
Intervention: JNJ-64232025 IV
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.
Intervention: Placebo
Subcutaneous (SC) Cohort
Participants will receive single dose of JNJ-64232025 or placebo as SC injection.
Intervention: JNJ-64232025 SC
Subcutaneous (SC) Cohort
Participants will receive single dose of JNJ-64232025 or placebo as SC injection.
Intervention: Placebo
Outcomes
Primary Outcomes
Number of Participants with Treatment-Emergent Adverse Events (TEAE) by Severity
Time Frame: Up to Day 113
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.
Number of Participants with Serious Adverse Events (SAE)
Time Frame: Up to Day 113
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.
Number of Participants with Clinically Significant Changes in Vital Signs
Time Frame: Up to Day 113
Number of participants with clinically significant changes in the vital signs including temperature, pulse/heart rate, respiratory rate, and blood pressure will be reported.
Number of Participants with ECG Abnormalities
Time Frame: Up to Day 113
Number of participants with electrocardiogram (ECG) abnormalities will be reported.
Number of Participants with Clinical Laboratory Abnormalities
Time Frame: Up to Day 113
Number of participants with clinical laboratory abnormalities, including cytomegalovirus (CMV) and Epstein-Barr virus (EBV) viral loads, will be reported.
Secondary Outcomes
- Maximum Observed Plasma Concentration (Cmax) of JNJ-64232025(Up to Day 113)
- Time to Reach Maximum Observed Plasma Concentration (Tmax) of JNJ-64232025(Up to Day 113)
- Area Under the Plasma Concentration-Time Curve from Time Zero to Infinity with Extrapolation of the Terminal Phase (AUC[0-infinity])(Up to Day 113)
- Area Under the Plasma Concentration-Time Curve from Time Zero to the Time Corresponding to the Last Quantifiable Concentration (AUC[0-last])(Up to Day 113)
- Terminal Half-Life (t1/2)(Up to Day 113)
- Total Systemic Clearance (C/L)(Up to Day 113)
- Apparent Total Systemic Clearance After Extravascular Administration (CL/F)(Up to Day 113)
- Volume of Distribution Based on Terminal Phase (Vz)(Up to Day 113)
- Apparent Volume of Distribution Based on Terminal Phase After Extravascular Administration (Vz/F)(Up to Day 113)
- Relative SC Bioavailability (F%)(Up to Day 113)
- Number of Participants with Anti-JNJ 64232025 Antibodies(Up to Day 113)
- Number of Participants with Anti-KLH and Anti-Tetanus Antibodies(Up to Day 113)