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

NCT03550950 | Completed Phase 1 DMC

• 3 other identifiers: CR1084482017-003986-8264232025ARA1001
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  Up to Day 113

• Number of Participants with ECG Abnormalities

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

  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.

  Up to Day 113

Secondary Outcomes (12)

• 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

Study Arms (2)

Single Ascending Dose (SAD) IV Cohort

EXPERIMENTAL

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

Drug: JNJ-64232025 IV; Drug: Placebo

Subcutaneous (SC) Cohort

EXPERIMENTAL

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

Drug: JNJ-64232025 SC; Drug: Placebo

Interventions

JNJ-64232025 IV DRUG

JNJ-64232025 will be administered as IV infusion.

Single Ascending Dose (SAD) IV Cohort

JNJ-64232025 SC DRUG

JNJ-64232025 will be administered as SC injection.

Subcutaneous (SC) Cohort

Placebo DRUG

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

Single Ascending Dose (SAD) IV Cohort; Subcutaneous (SC) Cohort

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (1)

SGS Life Science Services

Antwerp, 2060, Belgium

Location

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2018
• First Posted: June 11, 2018
• Study Start: June 1, 2018
• Primary Completion: February 5, 2019
• Study Completion: February 5, 2019
• Last Updated: February 3, 2025

Record last verified: 2025-01

Locations

BE (1)