A Study of JNJ-80202135 in Healthy Chinese Adult Participants

NCT05151692 | Completed Phase 1 FDA Drug

• 2 other identifiers: CR10910080202135EDI1002
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (9)

• Percentage of Participants with Adverse Events (AEs)

  Up to Day 57

• Percentage of Participants with Serious Adverse Event (SAE)

  Up to Day 57

• Percentage of Participants with Adverse Event of Special Interests (AESIs)

  Up to Day 57

• Percentage of Participants with Abnormalities in Physical Examinations

  Up to Day 57

• Percentage of Participants with Abnormalities in 12-Lead Electrocardiogram (ECG) Values

  Up to Day 57

Study Arms (3)

Cohort 1: Nipocalimab

EXPERIMENTAL

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

Drug: Nipocalimab

Cohort 2: Nipocalimab

EXPERIMENTAL

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

Drug: Nipocalimab

Cohort 3: Nipocalimab

EXPERIMENTAL

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

Drug: Nipocalimab

Interventions

Nipocalimab DRUG

Nipocalimab will be administered as an IV infusion.

Also known as: JNJ-80202135

Cohort 1: Nipocalimab; Cohort 2: Nipocalimab; Cohort 3: Nipocalimab

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (1)

Peking University Third Hospital

Beijing, 100191, China

Location

Related Publications (1)

• 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.

  PMID: 40389701 DERIVED

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2021
• First Posted: December 9, 2021
• Study Start: May 30, 2022
• Primary Completion: September 9, 2022
• Study Completion: September 9, 2022
• Last Updated: October 26, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)