- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05151692
A Study of JNJ-80202135 in Healthy Chinese Adult Participants
October 25, 2022 updated by: Janssen Research & Development, LLC
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
The purpose of this study is to assess the pharmacokinetic (PK) of nipocalimab following single intravenous (IV) administration in healthy Chinese participants.
Study Overview
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Beijing, China, 100191
- Peking University Third Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cohort 1: Nipocalimab
Participants will receive a single intravenous (IV) dose of nipocalimab Dose 1 on Day 1.
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Nipocalimab will be administered as an IV infusion.
Other Names:
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Experimental: Cohort 2: Nipocalimab
Participants will receive a single IV dose of nipocalimab Dose 2 on Day 1.
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Nipocalimab will be administered as an IV infusion.
Other Names:
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Experimental: Cohort 3: Nipocalimab
Participants will receive a single IV dose of nipocalimab Dose 3 on Day 1.
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Nipocalimab will be administered as an IV infusion.
Other Names:
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What is the study measuring?
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
Time Frame: Up to Day 29
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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.
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Up to Day 29
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Area Under the Analyte Concentration Versus Time Curve From Time Zero to Infinite Time (AUC [0-Infinity]) of Nipocalimab
Time Frame: Up to Day 29
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AUC (0-Infinity) is defined as area under the analyte concentration versus time curve from time zero to infinite time of nipocalimab.
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Up to Day 29
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Last Measurable Serum Concentration (Clast) of Nipocalimab
Time Frame: Up to Day 29
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Clast is defined as last measurable serum concentration of nipocalimab.
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Up to Day 29
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Maximum Observed Serum Concentration (Cmax) of Nipocalimab
Time Frame: Up to Day 29
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Cmax is defined as maximum observed serum concentration of nipocalimab.
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Up to Day 29
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Time of Last Measurable Serum Concentration (Tlast) of Nipocalimab
Time Frame: Up To Day 29
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Tlast is defined as time of last measurable serum concentration of nipocalimab.
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Up To Day 29
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Time to Reach the Maximum Observed Serum Concentration (Tmax) of Nipocalimab
Time Frame: Up to Day 29
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Tmax is defined as time to reach the maximum observed serum concentration of nipocalimab.
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Up to Day 29
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Apparent Elimination Half-life (T1/2) of Nipocalimab
Time Frame: Up to Day 29
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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.
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Up to Day 29
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Total Systemic Clearance (CL) of Nipocalimab
Time Frame: Up to Day 29
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CL is defined as total systemic clearance of nipocalimab after intravenous (IV) administration.
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Up to Day 29
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Volume of Distribution (Vz) of Nipocalimab
Time Frame: Up to Day 29
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Vz is defined as volume of distribution based on terminal phase after IV administration of nipocalimab.
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Up to Day 29
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants with Adverse Events (AEs)
Time Frame: Up to Day 57
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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.
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Up to Day 57
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Percentage of Participants with Serious Adverse Event (SAE)
Time Frame: Up to Day 57
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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.
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Up to Day 57
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Percentage of Participants with Adverse Event of Special Interests (AESIs)
Time Frame: Up to Day 57
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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.
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Up to Day 57
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Percentage of Participants with Abnormalities in Physical Examinations
Time Frame: Up to Day 57
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Percentage of participants with abnormalities in physical examinations (including height and body weight) will be reported.
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Up to Day 57
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Percentage of Participants with Abnormalities in 12-Lead Electrocardiogram (ECG) Values
Time Frame: Up to Day 57
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Percentage of participants with abnormalities in 12-lead ECG values will be reported.
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Up to Day 57
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Percentage of Participants with Abnormalities in Vital Signs
Time Frame: Up to Day 57
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Percentage of participants with abnormalities in vital signs (temperature axillary, pulse/heart rate, blood pressure [systolic and diastolic]) will be reported.
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Up to Day 57
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Percentage of Participants with Abnormalities in Clinical Laboratory Values
Time Frame: Up to Day 57
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Percentage of participants with abnormalities in clinical laboratory values (hematology, clinical chemistry, urinalysis) will be reported.
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Up to Day 57
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Percentage of Participants with Anti-drug Antibodies to Nipocalimab
Time Frame: Day 1, Day 15, Day 29 and Day 57
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Percentage of participants with anti-drug antibodies to nipocalimab will be reported.
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Day 1, Day 15, Day 29 and Day 57
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Change from Baseline Over Time in Total Immunoglobulin-G (IgG) Serum Levels
Time Frame: Baseline up to Day 57
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Change from baseline over time in total IgG serum levels will be reported.
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Baseline up to Day 57
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 30, 2022
Primary Completion (Actual)
September 9, 2022
Study Completion (Actual)
September 9, 2022
Study Registration Dates
First Submitted
December 7, 2021
First Submitted That Met QC Criteria
December 7, 2021
First Posted (Actual)
December 9, 2021
Study Record Updates
Last Update Posted (Actual)
October 26, 2022
Last Update Submitted That Met QC Criteria
October 25, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- CR109100
- 80202135EDI1002 (Other Identifier: Janssen Research & Development, LLC)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
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
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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