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| ID | Type | Description | Link |
|---|---|---|---|
| 63733657ALZ1001 | Other Identifier | Janssen Research & Development, LLC |
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The purpose of this study is to assess the pharmacokinetics (PK) of JNJ-63733657 following single intravenous (IV) dose administration in healthy Chinese participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JNJ-63733657 | Experimental | Participants will receive a single dose of JNJ-63733657 as an intravenous (IV) infusion on Day 1. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-63733657 | Drug | JNJ-63733657 will be administered as an IV infusion. |
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| Measure | Description | Time Frame |
|---|---|---|
| Serum Concentrations of JNJ-63733657 | Serum samples will be analyzed to determine concentrations of JNJ-63733657 using a validated, specific, and sensitive Immunoassay method. | Up to Week 13 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with Treatment-emergent Adverse Events (TEAEs) by Severity | An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product. An AE 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. An assessment of severity grade will be made using the following general categorical descriptors: Mild, Moderate, and Severe. |
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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 |
|---|---|---|---|---|---|---|
| Peking University Third Hospital | Beijing | 100089 | China |
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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| Up to Week 13 |
| Percentage of Participants with Discontinuations due to AEs | Percentage of participants with discontinuations due to AEs will be reported. | Up to Week 17 |
| Percentage of Participants with Serious Adverse Events (SAEs) | An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product. | Up to Week 17 |
| Percentage of Participants with Clinically Significant Changes in Vital Signs | Percentage of participants with clinically significant changes in vital signs (including temperature [axillary], pulse/heart rate, respiratory rate, and blood pressure) will be reported. | Up to Week 17 |
| Percentage of Participants with Clinically Significant Changes in Electrocardiograms (ECGs) | Percentage of participants with clinically significant changes in ECGs will be reported. | Up to Week 17 |
| Percentage of Participants with Clinically Significant Changes in Clinical Safety Laboratory Parameters | Percentage of participants with clinically significant changes in clinical safety laboratory parameters (including hematology, chemistry, and urinalyses) will be reported. | Up to Week 17 |
| Percentage of Participants with Anti-drug Antibodies to JNJ-63733657 | Percentage of participants with anti-drug antibodies to JNJ-63733657 will be reported. | Up to Week 13 |