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| ID | Type | Description | Link |
|---|---|---|---|
| 77474462ADM1001 | Other Identifier | Janssen Research & Development, LLC |
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The purpose of this study is to assess the pharmacokinetics (PK) of JNJ-77474462 after single subcutaneous (SC) or intravenous (IV) administrations and the effect of formulation concentrations on PK of JNJ-77474462 in healthy participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A: JNJ-77474462 SC (Wave 1) | Experimental | Participants will receive single dose of JNJ-77474462 subcutaneously (SC). |
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| Cohort B: JNJ-77474462 SC (Wave 1) | Experimental | Participants will receive single dose of JNJ-77474462 SC. |
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| Cohort C: JNJ-77474462 SC (Wave 1) | Experimental | Participants will receive single dose of JNJ-77474462 SC. |
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| Cohort D: JNJ-77474462 SC (Wave 1) | Experimental | Participants will receive single dose of JNJ-77474462 SC. |
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| Cohort E: JNJ-77474462 IV (Wave 1) | Experimental | Participants will receive single dose of JNJ-77474462 intravenously (IV). |
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| Cohort F: JNJ-77474462 SC (Wave 2) | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-77474462 | Drug | Participants will receive JNJ-77474462 as a liquid formulation in Cohort A, B, C, D, F and G (SC injection) and in Cohort E, H and I (IV infusion). |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of JNJ-77474462 | Cmax is the maximum observed plasma concentration. | Up to Week 12 |
| Area Under the Plasma Concentration Versus Time Curve from Time Zero to Infinity with Extrapolation of the Terminal Phase (AUC[0-infinity]) of JNJ-77474462 | AUC(0-infinity) is defined as area under the plasma concentration versus time curve from time zero to infinity with extrapolation of the terminal phase of JNJ-77474462. | Up to Week 12 |
| Area Under the Plasma Concentration Versus Time Curve from Time Zero to the Time Corresponding to the Last Quantifiable Concentration (AUC[0-last]) of JNJ-77474462 | AUC(0-last) is defined as area under the plasma concentration versus time curve from time zero to the time corresponding to the last quantifiable concentration of JNJ-77474462. | Up to Week 12 |
| Terminal Half-Life (T1/2) of JNJ-77474462 | T1/2 is defined as the time measured for the plasma concentration to decrease by 1 half of its original concentration. | Up to Week 12 |
| Absolute Subcutaneous (SC) Bioavailability (F%) | (F%) is defined as absolute SC bioavailability to be calculated using the following equation: AUC(0-infinity) SC/mean AUC(0-infinity) IV * 100 percent (%). | Up to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with Treatment-emergent Adverse Events (TEAE) | 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 adverse events (AEs) with onset or worsening on or after date of first dose of study treatment. | Up to Week 12 |
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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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| ID | Term |
|---|---|
| C000604877 | bermekimab |
| D053590 | Interleukin 1 Receptor Antagonist Protein |
| ID | Term |
|---|---|
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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Participants will receive single dose of JNJ-77474462 SC.
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| Cohort G: JNJ-77474462 SC (Wave 2) | Experimental | Participants will receive single dose of JNJ-77474462 SC. |
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| Cohort H: JNJ-77474462 IV (Wave 2) | Experimental | Participants will receive single dose of JNJ-77474462 IV. |
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| Cohort I: JNJ-77474462 IV (Wave 2) | Experimental | Participants will receive single dose of JNJ-77474462 IV. |
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| Cohort J: Anakinra SC | Active Comparator | Participants will receive a SC injection of anakinra once daily for 3 days. |
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| Anakinra | Drug | Participants will receive a SC injection of anakinra 100 mg once daily for 3 days. |
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| Percentage of Participants with Serious Adverse Events (SAE) | 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 12 |
| Number of Participants with Clinically Significant Changes in Vital Signs | Number of participants with clinically significant changes in vital signs (including body temperature, resting [supine] pulse/heart rate, respiratory rate and blood pressure) will be reported. | Up to Week 12 |
| Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG) | Number of participants with clinically significant changes ECG will be reported. | Up to Week 12 |
| Number of Participants with Clinically Significant Changes in Laboratory Findings | Number of participants with clinically significant changes in laboratory findings (that is, hematology, clinical chemistry, urinalysis) will be reported. | Up to Week 12 |
| Number of Participants with Anti-JNJ-77474462 Antibodies | Number of participants with anti-drug antibodies to JNJ-77474462 will be reported. | Up to Week 12 |
| D011506 | Proteins |
| D001685 | Biological Factors |