Clinical trial NCT05151692: A Study of JNJ-80202135 in Healthy Chinese Adult Participants
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2021-12-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

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


Eligibility criteria: 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)

Primary outcomes:
measure: Area Under the Serum Concentration Versus Time Curve From Time Zero to Time of the Last Measurable Concentration (AUC[0-last]) of Nipocalimab
timeFrame: Up to Day 29
measure: Area Under the Analyte Concentration Versus Time Curve From Time Zero to Infinite Time (AUC [0-Infinity]) of Nipocalimab
timeFrame: Up to Day 29
measure: Last Measurable Serum Concentration (Clast) of Nipocalimab
timeFrame: Up to Day 29
measure: Maximum Observed Serum Concentration (Cmax) of Nipocalimab
timeFrame: Up to Day 29
measure: Time of Last Measurable Serum Concentration (Tlast) of Nipocalimab
timeFrame: Up To Day 29
measure: Time to Reach the Maximum Observed Serum Concentration (Tmax) of Nipocalimab
timeFrame: Up to Day 29
measure: Apparent Elimination Half-life (T1/2) of Nipocalimab
timeFrame: Up to Day 29
measure: Total Systemic Clearance (CL) of Nipocalimab
timeFrame: Up to Day 29
measure: Volume of Distribution (Vz) of Nipocalimab
timeFrame: Up to Day 29
Secondary outcomes:
measure: Percentage of Participants with Adverse Events (AEs)
timeFrame: Up to Day 57
measure: Percentage of Participants with Serious Adverse Event (SAE)
timeFrame: Up to Day 57
measure: Percentage of Participants with Adverse Event of Special Interests (AESIs)
timeFrame: Up to Day 57
measure: Percentage of Participants with Abnormalities in Physical Examinations
timeFrame: Up to Day 57
measure: Percentage of Participants with Abnormalities in 12-Lead Electrocardiogram (ECG) Values
timeFrame: Up to Day 57
measure: Percentage of Participants with Abnormalities in Vital Signs
timeFrame: Up to Day 57
measure: Percentage of Participants with Abnormalities in Clinical Laboratory Values
timeFrame: Up to Day 57
measure: Percentage of Participants with Anti-drug Antibodies to Nipocalimab
timeFrame: Day 1, Day 15, Day 29 and Day 57
measure: Change from Baseline Over Time in Total Immunoglobulin-G (IgG) Serum Levels
timeFrame: Baseline up to Day 57
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: