A Study of JNJ-80202135 in Healthy Chinese Adult Participants

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05151692
• Other study ID #: CR109100
• Secondary ID: 80202135EDI1002
• Status: Completed
• Phase: Phase 1
• Start date: May 30, 2022
• Est. completion date: September 9, 2022

Study information

• Verified date: October 2022
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the pharmacokinetic (PK) of nipocalimab following single intravenous (IV) administration in healthy Chinese participants.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 9, 2022
• Est. primary completion date: September 9, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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)

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Nipocalimab
Nipocalimab will be administered as an IV infusion.

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Last Measurable Serum Concentration (Clast) of Nipocalimab	Clast is defined as last measurable serum concentration of nipocalimab.	Up to Day 29
Primary	Maximum Observed Serum Concentration (Cmax) of Nipocalimab	Cmax is defined as maximum observed serum concentration of nipocalimab.	Up to Day 29
Primary	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
Primary	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
Primary	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
Primary	Total Systemic Clearance (CL) of Nipocalimab	CL is defined as total systemic clearance of nipocalimab after intravenous (IV) administration.	Up to Day 29
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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