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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-003986-82 | EudraCT Number | ||
| 64232025ARA1001 | Other Identifier | Janssen Research & Development, LLC |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Subcutaneous (SC) Cohort | Experimental | Participants will receive single dose of JNJ-64232025 or placebo as SC injection. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-64232025 IV | Drug | JNJ-64232025 will be administered as IV infusion. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of JNJ-64232025 | The Cmax is the maximum observed plasma concentration of JNJ-64232025. | Up to Day 113 |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) of JNJ-64232025 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SGS Life Science Services | Antwerp | 2060 | Belgium |
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| JNJ-64232025 SC | Drug | JNJ-64232025 will be administered as SC injection. |
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| Placebo | Drug | Matching placebo will be administered as IV infusion or SC injection. |
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The Tmax is defined as actual sampling time to reach maximum observed plasma concentration 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]) | The AUC(0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(0-last) and C(0-last)/lambda(z); wherein AUC(0-last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(0-last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant. | 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]) | The AUC(0-last) is the area under the plasma concentration-time curve from time zero to last quantifiable time. | Up to Day 113 |
| Terminal Half-Life (t1/2) | The t1/2 is the time measured for the plasma concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z). | Up to Day 113 |
| Total Systemic Clearance (C/L) | Systemic clearance is a quantitative measure of the rate at which a drug substance is removed from the body. The total systemic clearance after intravenous dose was estimated by dividing the total administered dose by the plasma AUC(0-infinity). | Up to Day 113 |
| Apparent Total Systemic Clearance After Extravascular Administration (CL/F) | Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. CL/F is the apparent total systemic clearance after extravascular administration. | Up to Day 113 |
| Volume of Distribution Based on Terminal Phase (Vz) | Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. | Up to Day 113 |
| Apparent Volume of Distribution Based on Terminal Phase After Extravascular Administration (Vz/F) | Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. Apparent volume of distribution after subcutaneous dose (Vz/F) is influenced by the fraction absorbed. | Up to Day 113 |
| Relative SC Bioavailability (F%) | Relative SC bioavailability will be calculated using the following equation: F (%[percent]) = AUC(0-infinity),SC/ mean AUC(0-infinity),IV *100%. | Up to Day 113 |
| Number of Participants with Anti-JNJ 64232025 Antibodies | Number of participants with anti-JNJ-64232025 antibodies will be assessed. | Up to Day 113 |
| Number of Participants with Anti-KLH and Anti-Tetanus Antibodies | Number of participants with antibodies to anti-Keyhole Limpet Hemocyanin (KLH) and anti-tetanus will be assessed. | Up to Day 113 |