A Study of JNJ-80202135 in Healthy Chinese Adult Participants

NCT ID: NCT05151692

Last Updated: 2022-10-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-30
• Study Completion Date: 2022-09-09

Brief Summary

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

Conditions

Healthy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Cohort 1: Nipocalimab

Participants will receive a single intravenous (IV) dose of nipocalimab Dose 1 on Day 1.

Group Type: EXPERIMENTAL

Nipocalimab

Intervention Type: DRUG

Nipocalimab will be administered as an IV infusion.

Cohort 2: Nipocalimab

Participants will receive a single IV dose of nipocalimab Dose 2 on Day 1.

Group Type: EXPERIMENTAL

Nipocalimab

Intervention Type: DRUG

Nipocalimab will be administered as an IV infusion.

Cohort 3: Nipocalimab

Participants will receive a single IV dose of nipocalimab Dose 3 on Day 1.

Group Type: EXPERIMENTAL

Nipocalimab

Intervention Type: DRUG

Nipocalimab will be administered as an IV infusion.

Interventions

Nipocalimab

Nipocalimab will be administered as an IV infusion.

Intervention Type: DRUG

Other Intervention Names

JNJ-80202135

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Peking University Third Hospital

Beijing, , China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 40389701 (View on PubMed)

Other Identifiers

80202135EDI1002

Identifier Type: OTHER

Identifier Source: secondary_id

CR109100

Identifier Type: -

Identifier Source: org_study_id