A Study of JNJ-80202135 in Healthy Chinese Adult Participants

Study Overview
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Brief Summary
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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.

Official Title
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A Sequential, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of JNJ-80202135 Following a Single Intravenous Administration in Healthy Chinese Adult Participants

Conditions
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Healthy

Intervention / Treatment
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* Drug: Nipocalimab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy on the basis of physical examination, medical history, vital signs and 12-lead electrocardiogram (ECG) performed at screening. If there are any abnormalities, they must be assessed as not clinically significant by the investigator and this determination must be recorded in the participant's source documents and initialed by the investigator Healthy on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel hematology, or urinalysis are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant. This determination must be recorded in the participant's source documents and initialed by the investigator Serum immunoglobulin G (IgG) level must be greater than (>) the lower limit of normal at screening Body mass index (BMI; weight [kilograms {kg}] per height^2 [meter square {m^2}]) between 18 and 27.9 kilograms per meter square (kg/m^2) (inclusive), and body weight not less than 50 kg and less than or equal to (<=) 110 kg at screening A woman of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin [beta-hCG]) at Week 0 prior to administration of study intervention Exclusion Criteria: Known allergies, hypersensitivity, or intolerance to nipocalimab or its excipients Serum albumin below the lower limit of normal at screening Use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for paracetamol, acetaminophen, contraceptives, and hormonal replacement therapy within 14 days before the first dose of the study drug is scheduled until completion of the study Had major surgery, (example: requiring general anesthesia) within 12 weeks before screening, or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study or within 8 weeks after the last dose of study intervention administration Has an active, acute or a chronic infection (examples: bronchiectasis, chronic osteomyelitis, chronic pyelonephritis) or requires chronic treatment with anti-infectives (examples: antibiotics, antivirals)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1: Nipocalimab<br>Participants will receive a single intravenous (IV) dose of nipocalimab Dose 1 on Day 1. | Drug: Nipocalimab<br>* Nipocalimab will be administered as an IV infusion.<br>* Other names: JNJ-80202135;|
| Experimental: Cohort 2: Nipocalimab<br>Participants will receive a single IV dose of nipocalimab Dose 2 on Day 1. | Drug: Nipocalimab<br>* Nipocalimab will be administered as an IV infusion.<br>* Other names: JNJ-80202135;|
| Experimental: Cohort 3: Nipocalimab<br>Participants will receive a single IV dose of nipocalimab Dose 3 on Day 1. | Drug: Nipocalimab<br>* Nipocalimab will be administered as an IV infusion.<br>* Other names: JNJ-80202135;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 |