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| ID | Type | Description | Link |
|---|---|---|---|
| 77474462HDS1001 | Other Identifier | Janssen Research & Development, LLC |
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The development of bermekimab in Immunology is stopped
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The purpose of this study is to assess the pharmacokinetics (PK) of JNJ-77474462 following single ascending dose subcutaneous (SC) administration to healthy Chinese participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JNJ-77474462 | Experimental | Participants will receive a single subcutaneous (SC) Dose 1 of JNJ-77474462 on Day 1 in Cohort 1, a single SC Dose 2 of JNJ-77474462 on Day 1 in Cohort 2 and a single SC Dose 3 of JNJ-77474462 on Day 1 in Cohort 3. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-77474462 | Drug | JNJ-77474462 will be administered subcutaneously. |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Serum Concentration (Cmax) of JNJ-77474462 | Cmax is defined as the maximum observed serum concentration of JNJ-77474462. | Up to Day 85 |
| Time to Reach Maximum Observed Serum Concentration (Tmax) of JNJ-77474462 | Tmax is defined as the time to reach maximum observed serum concentration of JNJ-77474462. | Up to Day 85 |
| Area Under the Serum Concentration Versus Time Curve from Time Zero to Infinity (AUC [0-Infinity]) of JNJ-77474462 | AUC (0-infinity) is defined as the area under the serum concentration of JNJ-77474462 versus time curve from time zero to infinity with extrapolation of the terminal phase. | Up to Day 85 |
| Area Under the Serum 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 the area under the serum concentration of JNJ-77474462 versus time curve from time zero to the time corresponding to the last quantifiable concentration. | Up to Day 85 |
| Terminal Half-life (T1/2) of JNJ-77474462 | T1/2 will be reported. T1/2 is defined as the terminal half-life of JNJ-77474462. | Up to Day 85 |
| Apparent Total Systemic Clearance after Extravascular Administration (CL/F) of JNJ-77474462 | CL/F is defined as the apparent total systemic clearance after extravascular administration of JNJ-77474462. | Up to Day 85 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with Treatment-emergent Adverse Events (TEAEs) by Severity | Percentage of participants with TEAEs by severity will be reported. 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. Any AE occurring at or after the initial administration of study intervention through Day 85 is considered to be treatment-emergent. Severity will be assessed based on the following categories: a) Mild: Awareness of symptoms that are easily tolerated, causing minimal discomfort and not interfering with everyday activities, b) Moderate: Sufficient discomfort is present to cause interference with normal activity and c) Severe: Extreme distress, causing significant impairment of functioning or incapacitation. Prevents normal everyday activities. |
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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 |
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The data sharing policy of the Janssen Pharmaceutical Companies of Johnson and 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 |
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| Apparent Volume of Distribution Based on Terminal Phase After Extravascular Administration (Vz/F) of JNJ-77474462 |
Vz/F is defined as the apparent volume of distribution based on terminal phase after extravascular administration of JNJ-77474462. |
| Up to Day 85 |
| Up to Day 85 |
| Percentage of Participants with Serious Adverse Events (SAEs) | Percentage of participants with SAEs will be reported. A SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect, is suspected transmission of any infectious agent via a medicinal product, is medically important to prevent one of the outcomes listed above. | Up to Day 85 |
| 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 and blood pressure) will be reported. | Up to Day 85 |
| Number of Participants with Clinically Significant Changes in Electrocardiograms (ECGs) | Number of participants with clinically significant changes in ECGs will be reported. | Up to Day 85 |
| Number of Participants with Clinically Significant Changes in Hematology Parameters | Number of participants with clinically significant changes in hematology parameters will be reported. | Up to Day 85 |
| Number of Participants with Clinically Significant Changes in Chemistry Parameters | Number of participants with clinically significant changes in chemistry parameters will be reported. | Up to Day 85 |
| Number of Participants with Clinically Significant Changes in Urinalysis | Number of participants with clinically significant changes in urinalysis will be reported. | Up to Day 85 |
| Number of Participants with Presence of Antibodies to JNJ-77474462 | Number of participants with presence of antibodies to JNJ-77474462 will be reported. The detection and characterization of antibodies to JNJ-77474462 will be performed using a validated drug-tolerant method. | Up to Day 85 |