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| ID | Type | Description | Link |
|---|---|---|---|
| 77474462ADM1002 | Other Identifier | Janssen Research & Development, LLC |
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The purpose of the study is to assess the safety and tolerability of JNJ-77474462 following single subcutaneous (SC) administration to healthy participants of Japanese descent.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: JNJ-77474462 (Low Dose) or Placebo | Experimental | Participants will receive single low dose of JNJ-77474462 or matching placebo as subcutaneous (SC) injection. |
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| Cohort 2: JNJ-77474462 (Medium Dose) or Placebo | Experimental | Participants will receive single medium dose of JNJ-77474462 or matching placebo as SC injection. |
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| Cohort 3: JNJ-77474462 (High Dose) or Placebo | Experimental | Participants will receive single high dose of JNJ-77474462 or matching placebo as SC injection. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-77474462 | Drug | JNJ-77474462 will be administered as SC injection. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Treatment-Emergent Adverse Events (TEAEs) | An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment. | Up to Week 16 |
| Number of Participants with Serious Adverse Events (SAEs) | A 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 Week 16 |
| Number of Participants with Treatment-Emergent Adverse Events (TEAEs) by System Organ Class (SOC) Reported in two or More Participants | An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment. | Up to Week 16 |
| Number of Participants with Clinically Significant Changes in Vital Signs | Number of participants with clinically significant changes in vital signs (temperature, pulse/heart rate, respiratory rate, blood pressure) will be reported. | Up to Week 12 |
| Number of Participants with Clinically Significant Changes in Electrocardiograms (ECGs) Waveform | Number of participants with clinically significant changes in ECGs waveform (example: changes in T-wave morphology or the occurrence of U-waves) will be reported. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Concentration (Cmax) | Cmax is the maximum observed concentration. | Up to Week 12 |
| Area Under the Plasma/Serum Concentration-time Curve from Time Zero to Infinite Time (AUC[0-infinity]) |
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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 |
|---|---|---|---|---|---|---|
| Nucleus Network, Q-Pharm Pty Ltd | Herston | 4006 | Australia |
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency.
As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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| Placebo | Drug | Matching placebo to JNJ-77474462 will be administered as SC injection. |
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| Up to Week 12 |
| Number of Participants with Clinically Significant Changes in Hematology | Number of participants with clinically significant changes in hematology (such as platelet count, Red blood cell count [RBS], Hemoglobin, Hematocrit, RBC Indices, WBCs) will be reported. | Up to Week 12 |
| Number of Participants with Clinically Significant Changes in Chemistry | Number of participants with clinically significant changes in chemistry (such as Sodium, Potassium, Chloride, Bicarbonate,glucose, Total bilirubin, Uric acid) will be reported. | Up to Week 12 |
| Number of Participants with Clinically Significant Changes in Urinalysis | Number of participants with clinically significant changes in urinalysis (such as Specific gravity, pH, Glucose,Protein, WBCs, Bacteria) will be reported. | Up to Week 12 |
AUC(0-infinity) is defined area under the plasma/serum concentration versus time curve from time zero to infinity with extrapolation of the terminal phase.
| Up to Week 12 |
| Area Under the Plasma/Serum Concentration-time Curve from Time Zero To Time Of the Last Quantifiable Concentrations (AUC[0-last]) | AUC(0-last) is defined as area under the plasma/serum concentration versus time curve from time zero to the time corresponding to the last quantifiable concentration. | Up to Week 12 |
| Time to Reach Maximum Observed Concentration (Tmax) | Tmax is the time to reach maximum observed concentration. | Up to Week 12 |
| Terminal Half-life (T1/2) | T1/2 is the terminal half-life. | Up to Week 12 |
| Apparent Total Systemic Clearance (CL/F) | CL/F is the apparent total systemic clearance after extravascular administration. | Up to Week 12 |
| Apparent Volume of Distribution (Vz/F) | Vz/F is the apparent volume of distribution based on terminal phase after extravascular administration. | Up to Week 12 |
| Number of Participants with Antibodies to JNJ-77474462 | Number of participants with antibodies to JNJ-77474462 in participants receiving active study active intervention in total and by intervention group will be reported. | Up to Week 12 |
| ID | Term |
|---|---|
| C000604877 | bermekimab |
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