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HealthyPhase 1NCT05151692

A Study of JNJ-80202135 in Healthy Chinese Adult Participants

A Phase 1 study testing Nipocalimab in people with Healthy, run by Janssen Research & Development, LLC at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Nipocalimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
30 May 2022to 9 Sep 2022
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

China1 site

  • Peking University Third Hospital

    Beijing, 100191

Other trials in China

About this study

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

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

Conditions
Healthy
Being tested
Nipocalimab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NipocalimabDrug

    Also called JNJ-80202135

    Nipocalimab will be administered as an IV infusion.

Study groups in NCT05151692
Study groupRoleWhat they receive
Cohort 1: NipocalimabExperimentalParticipants will receive a single intravenous (IV) dose of nipocalimab Dose 1 on Day 1.
Receives: Drug: Nipocalimab
Cohort 2: NipocalimabExperimentalParticipants will receive a single IV dose of nipocalimab Dose 2 on Day 1.
Receives: Drug: Nipocalimab
Cohort 3: NipocalimabExperimentalParticipants will receive a single IV dose of nipocalimab Dose 3 on Day 1.
Receives: Drug: Nipocalimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to Day 29

  2. 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.

    Measured: Up to Day 29

  3. Last Measurable Serum Concentration (Clast) of Nipocalimab

    Clast is defined as last measurable serum concentration of nipocalimab.

    Measured: Up to Day 29

  4. Maximum Observed Serum Concentration (Cmax) of Nipocalimab

    Cmax is defined as maximum observed serum concentration of nipocalimab.

    Measured: Up to Day 29

  5. Time of Last Measurable Serum Concentration (Tlast) of Nipocalimab

    Tlast is defined as time of last measurable serum concentration of nipocalimab.

    Measured: Up To Day 29

  6. 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.

    Measured: Up to Day 29

  7. 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.

    Measured: Up to Day 29

  8. Total Systemic Clearance (CL) of Nipocalimab

    CL is defined as total systemic clearance of nipocalimab after intravenous (IV) administration.

    Measured: Up to Day 29

  9. Volume of Distribution (Vz) of Nipocalimab

    Vz is defined as volume of distribution based on terminal phase after IV administration of nipocalimab.

    Measured: Up to Day 29

Secondary outcomes (9)

  1. 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.

    Measured: Up to Day 57

  2. 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.

    Measured: Up to Day 57

  3. 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.

    Measured: Up to Day 57

  4. Percentage of Participants with Abnormalities in Physical Examinations

    Percentage of participants with abnormalities in physical examinations (including height and body weight) will be reported.

    Measured: Up to Day 57

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

    Percentage of participants with abnormalities in 12-lead ECG values will be reported.

    Measured: Up to Day 57

  6. 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.

    Measured: Up to Day 57

  7. 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.

    Measured: Up to Day 57

  8. Percentage of Participants with Anti-drug Antibodies to Nipocalimab

    Percentage of participants with anti-drug antibodies to nipocalimab will be reported.

    Measured: Day 1, Day 15, Day 29 and Day 57

  9. 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.

    Measured: Baseline up to Day 57

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2021
  2. Study start30 May 2022
  3. Primary completion9 Sep 2022
  4. Study completion9 Sep 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05151692
Sponsor's protocol ID
CR109100
Other IDs
80202135EDI1002
Status last verified
Oct 2022
First submitted
7 Dec 2021
Last updated
26 Oct 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Publications

  • 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.

    PubMed 40389701

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Nipocalimab in people with Healthy, run by Janssen Research & Development, LLC at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05151692, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2022.

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