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| ID | Type | Description | Link |
|---|---|---|---|
| 80202135EDI1002 | Other Identifier | Janssen Research & Development, LLC |
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The purpose of this study is to assess the pharmacokinetic (PK) of nipocalimab following single intravenous (IV) administration in healthy Chinese participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: Nipocalimab | Experimental | Participants will receive a single intravenous (IV) dose of nipocalimab Dose 1 on Day 1. |
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| Cohort 2: Nipocalimab | Experimental | Participants will receive a single IV dose of nipocalimab Dose 2 on Day 1. |
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| Cohort 3: Nipocalimab | Experimental | Participants will receive a single IV dose of nipocalimab Dose 3 on Day 1. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nipocalimab | Drug | Nipocalimab will be administered as an IV infusion. |
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| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Serum Concentration Versus Time Curve From Time Zero to Time of the Last Measurable Concentration (AUC[0-last]) of Nipocalimab | AUC(0-last) is defined as area under the serum concentration versus time curve from time 0 to time of the last measurable concentration of nipocalimab. | Up to Day 29 |
| Area Under the Analyte Concentration Versus Time Curve From Time Zero to Infinite Time (AUC [0-Infinity]) of Nipocalimab | AUC (0-Infinity) is defined as area under the analyte concentration versus time curve from time zero to infinite time of nipocalimab. | Up to Day 29 |
| Last Measurable Serum Concentration (Clast) of Nipocalimab | Clast is defined as last measurable serum concentration of nipocalimab. | Up to Day 29 |
| Maximum Observed Serum Concentration (Cmax) of Nipocalimab | Cmax is defined as maximum observed serum concentration of nipocalimab. | Up to Day 29 |
| Time of Last Measurable Serum Concentration (Tlast) of Nipocalimab | Tlast is defined as time of last measurable serum concentration of nipocalimab. | Up To Day 29 |
| Time to Reach the Maximum Observed Serum Concentration (Tmax) of Nipocalimab | Tmax is defined as time to reach the maximum observed serum concentration of nipocalimab. | Up to Day 29 |
| Apparent Elimination Half-life (T1/2) of Nipocalimab |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with Adverse Events (AEs) | An 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. | Up to Day 57 |
| Percentage of Participants with Serious Adverse Event (SAE) |
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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 | 100191 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40389701 | Derived | Li H, Liu J, Wang X, Zhao W, Zhang L, Niu X, Liu J, Dong Z. Pharmacokinetics, Pharmacodynamics, and Safety of Nipocalimab in Healthy Chinese Volunteers: A Single-Dose, Phase I Study. Neurol Ther. 2025 Aug;14(4):1439-1450. doi: 10.1007/s40120-025-00763-5. Epub 2025 May 19. |
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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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T1/2 is defined as apparent elimination half-life associated with the terminal slope of the semilogarithmic drug concentration-time curve of nipocalimab. |
| Up to Day 29 |
| Total Systemic Clearance (CL) of Nipocalimab | CL is defined as total systemic clearance of nipocalimab after intravenous (IV) administration. | Up to Day 29 |
| Volume of Distribution (Vz) of Nipocalimab | Vz is defined as volume of distribution based on terminal phase after IV administration of nipocalimab. | Up to Day 29 |
A 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; is medically important. |
| Up to Day 57 |
| Percentage of Participants with Adverse Event of Special Interests (AESIs) | Percentage of participants with AESIs will be reported. Treatment-emergent AEs associated with the following situations are considered as AESI: a) severe or medically significant or immediately life-threatening infections requiring IV anti-infective or operative/invasive intervention or requiring hospitalization or prolongation of existing hospitalization; b) hypoalbuminemia with albumin less than (<) 20 grams per liter (g/L). Any AE occurring at or after the initial administration of study intervention through end of study is considered to be treatment-emergent. | Up to Day 57 |
| Percentage of Participants with Abnormalities in Physical Examinations | Percentage of participants with abnormalities in physical examinations (including height and body weight) will be reported. | Up to Day 57 |
| Percentage of Participants with Abnormalities in 12-Lead Electrocardiogram (ECG) Values | Percentage of participants with abnormalities in 12-lead ECG values will be reported. | Up to Day 57 |
| Percentage of Participants with Abnormalities in Vital Signs | Percentage of participants with abnormalities in vital signs (temperature axillary, pulse/heart rate, blood pressure [systolic and diastolic]) will be reported. | Up to Day 57 |
| Percentage of Participants with Abnormalities in Clinical Laboratory Values | Percentage of participants with abnormalities in clinical laboratory values (hematology, clinical chemistry, urinalysis) will be reported. | Up to Day 57 |
| Percentage of Participants with Anti-drug Antibodies to Nipocalimab | Percentage of participants with anti-drug antibodies to nipocalimab will be reported. | Day 1, Day 15, Day 29 and Day 57 |
| Change from Baseline Over Time in Total Immunoglobulin-G (IgG) Serum Levels | Change from baseline over time in total IgG serum levels will be reported. | Baseline up to Day 57 |