Clinical trial NCT03550950: A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JNJ-64232025 in Healthy Participants
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2018-06-11
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Number of Participants with Treatment-Emergent Adverse Events (TEAE) by Severity
timeFrame: Up to Day 113
measure: Number of Participants with Serious Adverse Events (SAE)
timeFrame: Up to Day 113
measure: Number of Participants with Clinically Significant Changes in Vital Signs
timeFrame: Up to Day 113
measure: Number of Participants with ECG Abnormalities
timeFrame: Up to Day 113
measure: Number of Participants with Clinical Laboratory Abnormalities
timeFrame: Up to Day 113
Secondary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax) of JNJ-64232025
timeFrame: Up to Day 113
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) of JNJ-64232025
timeFrame: Up to Day 113
measure: Area Under the Plasma Concentration-Time Curve from Time Zero to Infinity with Extrapolation of the Terminal Phase (AUC[0-infinity])
timeFrame: Up to Day 113
measure: Area Under the Plasma Concentration-Time Curve from Time Zero to the Time Corresponding to the Last Quantifiable Concentration (AUC[0-last])
timeFrame: Up to Day 113
measure: Terminal Half-Life (t1/2)
timeFrame: Up to Day 113
measure: Total Systemic Clearance (C/L)
timeFrame: Up to Day 113
measure: Apparent Total Systemic Clearance After Extravascular Administration (CL/F)
timeFrame: Up to Day 113
measure: Volume of Distribution Based on Terminal Phase (Vz)
timeFrame: Up to Day 113
measure: Apparent Volume of Distribution Based on Terminal Phase After Extravascular Administration (Vz/F)
timeFrame: Up to Day 113
measure: Relative SC Bioavailability (F%)
timeFrame: Up to Day 113
measure: Number of Participants with Anti-JNJ 64232025 Antibodies
timeFrame: Up to Day 113
measure: Number of Participants with Anti-KLH and Anti-Tetanus Antibodies
timeFrame: Up to Day 113
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
facility: SGS Life Science Services
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: