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| ID | Type | Description | Link |
|---|---|---|---|
| 73763989HPB1004 | Other Identifier | Janssen Research & Development, LLC |
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The purpose of the study is to evaluate the single-dose Pharmacokinetics of JNJ-73763976 and JNJ-73763924 following a subcutaneous (SC) injection of JNJ-73763989 (JNJ-3989) in healthy Chinese adult participants at 2 different doses, Dose 1 (Panel A) or Dose 2 (Panel B).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Panel A: JNJ-73763989 | Experimental | Participants will receive single subcutaneous (SC) injection of low dose of JNJ-73763989 on Day 1. |
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| Panel B: J NJ-73763989 | Experimental | Participants will receive single SC injection of high dose of JNJ-73763989 on Day 1. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-73763989 | Drug | JNJ-73763989 will be administered (high or low dose) as single SC injection. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | An adverse event 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. | Up to 4 Weeks |
| Plasma Concentration of JNJ-73763989 | Plasma samples will be analyzed to determine concentrations of JNJ-73763989 (as the 2 triggers JNJ-73763976 and JNJ-73763924). | Predose up to 48 hours postdose (up to Day 3) |
| Urine Concentration of JNJ-73763989 | Urine samples will be analyzed to determine concentrations of JNJ-73763989 (as the 2 triggers JNJ-73763976 and JNJ-73763924). | Predose up to 48 hours postdose (up to Day 3) |
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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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36415122 | Derived | Li H, Niu X, Zhang Y, Zhang D, Zhang Y, Wang L, Miao Y, Jiang Y, Ji J, Chen Q, Wu X, Ediage EN, Kakuda TN, Biermer M. Pharmacokinetics, Safety, and Tolerability of the siRNA JNJ-73763989 in Healthy Chinese Adult Participants. Clin Pharmacol Drug Dev. 2023 Feb;12(2):175-180. doi: 10.1002/cpdd.1197. Epub 2022 Nov 22. |
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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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