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| ID | Type | Description | Link |
|---|---|---|---|
| 64304500CRD1002 | Other Identifier | Janssen Research & Development, LLC | |
| 2020-003559-14 | EudraCT Number |
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The purpose of this study is to evaluate the relative bioavailability of JNJ-64304500 after administration of two different formulations in healthy participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JNJ 64304500: Reference | Experimental | Participants (including individuals of Han Chinese background) will be randomized to receive a single subcutaneous dose of JNJ-64304500 reference formulation. |
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| JNJ 64304500: Test | Experimental | Participants (including individuals of Han Chinese background) will be randomized to receive a single subcutaneous dose of JNJ-64304500 test formulation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ 64304500 | Drug | Participants will receive a single subcutaneous dose of JNJ-64304500 reference formulation. |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Serum Concentration (Cmax) of JNJ-64304500 | Cmax is the maximum observed serum concentration. | Up to Day 113 |
| Area Under the Serum Concentration - Time Curve From Time Zero to Time Infinity (AUC [0-infinity]) of JNJ-64304500 | AUC (0-infinity) is the area under the serum concentration-time curve from time zero to infinity time, calculated as the sum of AUC (0-last) and C(last)/lambda(z); wherein AUC (0-last) is area under the serum concentration-time curve from time zero to last measurable concentration, C(last) is the last observed measurable concentration, and lambda(z) is apparent terminal elimination rate constant. | Up to Day 113 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Treatment-emergent Adverse Events (TEAEs) | An adverse event (AE) is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAEs are events between administration of study drug and up to Day 113 that are absent before treatment or that worsen relative to pre-treatment state. |
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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 |
|---|---|---|---|---|---|---|
| WCCT Global, LLC | Cypress | California | 90630 | United States |
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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| JNJ 64304500 | Drug | Participants will receive a single subcutaneous dose of JNJ-64304500 test formulation. |
|
| Up to Day 113 |
| Number of Participants with Clinically Significant Abnormalities in Vital Signs | Number of participants with clinically significant vital signs (temperature, pulse/heart rate, respiratory rate, and blood pressure: systolic and diastolic) will be reported. | Up to Day 113 |
| Number of Participants with Clinically Significant Abnormalities in Physical Examinations | Number of participants with clinically significant abnormalities in the physical examination (includes basic assessment of general appearance, respiratory and cardiovascular systems and the assessment of the skin at the administration area) will be reported. | Up to Day 113 |
| Number of Participants with Clinically Significant Abnormalities in Laboratory Parameters | Number of participants with clinically significant abnormalities in laboratory assessments like serum chemistry, hematology, and urinalysis will be reported. | Up to Day 113 |
| Number of Participants with Serum Antibodies to JNJ-64304500 | Number of participants with serum antibodies to JNJ-64304500 will be reported. | Up to Day 113 |