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| ID | Type | Description | Link |
|---|---|---|---|
| 64304500CRD1003 | Other Identifier | Janssen Research & Development, LLC |
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Sponsor Decision.
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The purpose of this study is to assess the pharmacokinetic following single subcutaneous administration of Dose 1 or Dose 2 of JNJ-64304500 in healthy Chinese adult participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: JNJ-64304500 | Experimental | Participants will receive single subcutaneous (SC) Dose 1 of JNJ-64304500 on Day 1. |
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| Cohort 2: JNJ-64304500 | Experimental | Participants will receive single SC Dose 2 of JNJ-64304500 on Day 1. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-64304500 | Drug | Participants will be administered with JNJ-64304500 SC (Dose 1 or 2) injection on Day 1. |
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| Measure | Description | Time Frame |
|---|---|---|
| Serum Concentration of JNJ-64304500 | Serum samples will be analyzed to determine concentrations of JNJ-64304500 using a validated, specific and sensitive immunoassay method. | Up to Day 113 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability | An AE is any untoward medical occurrence in a clinical study participant administered an investigational or non-investigational medicinal product. An AE does not necessarily have a causal relationship with the treatment. | Up to Day 113 |
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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 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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| Number of Participants with Antibodies to JNJ-64304500 |
Number of participants with antibodies to JNJ-64304500 will be reported. |
| Up to Day 113 |