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Safety, Tolerability, PK and PD of Nipocalimab (JNJ-80202135) Subcutaneous Injection via Syringe or Prefilled Autoinjector in Healthy Volunteers

InvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study involves adults who do not have any known illness and are considered healthy volunteers. Participants will receive the investigational drug nipocalimab, identified by the code JNJ-80202135, which is given by injection under the skin (subcutaneous) using either a regular syringe or a prefilled syringe autoinjector. The medication is supplied as a liquid that can be injected.

The purpose of the study is to evaluate the safety, tolerability, and how the drug works in the body at different dose levels. Volunteers will be assigned to receive several doses of the medication over a short period, and they will be monitored for any side effects, changes in vital signs, heart rhythm, and routine laboratory tests. Blood samples will be taken to measure the level of a common antibody called IgG, helping researchers understand how the drug affects this protein. Simple explanations are provided for any technical terms, such as describing “pharmacodynamics” as the way the drug influences the body’s processes.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment and consent

    After you agree to join the study, you will sign a consent form that explains what will happen and what information will be collected.

    Your eligibility as a healthy volunteer will be confirmed before any study procedures begin.

  2. Step 2

    Baseline assessments

    You will undergo a series of checks, including a physical exam, a 12‑lead ecg (a test that records the heart’s electrical activity), and laboratory tests such as blood work.

    These measurements establish your health status before receiving the study medication.

  3. Step 3

    First dose administration

    You will receive the first injection of nipocalimab (product name jnj-80202135).

    The medication is a sterile solution for injection that is given subcutaneously (under the skin) using either a normal syringe or a prefilled syringe autoinjector.

    The exact dose amount will be assigned by the study protocol; the label lists the dose as 0 u unit(s), which indicates that the dose will be determined by the study team for each participant.

  4. Step 4

    Subsequent dose administrations

    Additional doses of nipocalimab will be given on scheduled days according to the multiple‑dose design of the trial.

    Each dose will be administered in the same way as the first dose, using the same route (subcutaneous) and device (syringe or autoinjector).

    The frequency (for example, weekly or every other week) and total number of doses will be defined by the study schedule.

  5. Step 5

    Follow‑up visits and safety monitoring

    After each injection you will attend a follow‑up visit where vital signs, heart rhythm (12‑lead ecg), and physical condition are checked.

    Blood samples will be taken to measure the level of nipocalimab in your body and to assess changes in serum igg (a type of antibody).

    Any side effects, including treatment‑emergent adverse events, serious adverse events, or events that may require stopping the medication, will be recorded.

  6. Step 6

    Study completion

    Once the final scheduled dose and follow‑up assessments are completed, the study period ends for you.

    A final set of evaluations will be performed to summarize safety and the effect of the medication on serum igg levels.

    You will be informed that the study has concluded and any remaining study‑related information will be provided.

Who can join the trial?

5 criteria

  • Be at least 18 years old and no older than 60 years at the time of joining the study.
  • Be considered healthy after a physical check‑up, review of medical history, routine lab tests, vital signs (such as blood pressure and heart rate), and a 12‑lead ECG (a heart test that records electrical activity) performed during screening and again on the first day of the study; any small abnormalities must be judged by the doctor as not important.
  • Have normal results on standard laboratory tests done at screening (including a test called serum IgG, which measures a type of antibody) and on the day before the first dose (except for the IgG test); if any test result is outside the usual range, the doctor must decide it is not a health problem.
  • Have good veins that can be accessed easily in both arms for taking blood or giving the study medication.
  • Weigh at least 50 kilograms but not more than 110 kilograms, and have a Body Mass Index (BMI) between 18 and 32 kg/m² at the screening visit.

Who cannot join the trial?

5 criteria

  • Having a serious medical illness now or in the past, such as liver problems (hepatic insufficiency), kidney problems (renal insufficiency), heart disease (cardiovascular), lung disease (pulmonary), stomach or intestinal issues (gastrointestinal), hormone disorders (endocrine), nerve problems (neurologic), blood disorders (hematologic), joint or immune diseases (rheumatologic), mental health conditions (psychiatric), metabolism problems (metabolic), skin conditions (dermatological), a weak immune system (immune deficiency), eye problems (ophthalmological), or any other illness the doctor thinks would keep you from joining or affect the study results.
  • Having cancer now, or having had cancer within the last 3 years, except for certain skin cancers (localized basal cell carcinoma or squamous cell carcinoma) that were fully treated and have not returned for at least 12 weeks, or a pre‑cancerous condition of the cervix (carcinoma in situ) that was treated and has not returned for at least 12 weeks.
  • Being allergic, hypersensitive, or unable to tolerate nipocalimab or any of its inactive ingredients (excipients).
  • Currently receiving or having previously received allergy shots (allergy immunotherapy) because of severe allergic reactions (anaphylaxis).
  • Having had a severe immediate allergic reaction, such as anaphylaxis, to medicines that contain proteins, like other therapeutic proteins or monoclonal antibodies (mAbs).
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Investigated drugs

nipocalimab is an experimental medication being studied to see if it is safe and well‑tolerated when given under the skin. In this trial, healthy volunteers receive the drug using either a standard syringe or a prefilled autoinjector. Researchers are looking at how the body processes the medication and how it affects certain biological markers, but they are not testing it for treating a disease yet.

What is already known about the treatment

Nipocalimab - Nipocalimab is given as a liquid solution that is injected under the skin using a syringe or a prefilled autoinjector. It is currently an investigational drug that has not yet been approved and is being studied in early‑phase clinical trials. The antibody is being explored for treating immune‑system diseases that involve too much IgG, such as certain autoimmune conditions. It works by attaching to a receptor that recycles IgG antibodies, blocking this process and lowering overall IgG levels, and it is classified as a human monoclonal antibody that acts as an Fc‑Rn antagonist.

Investigated diseases

Immune system diseases - These are conditions in which the body’s defense system mistakenly attacks its own tissues. The immune response becomes overactive, causing inflammation and damage to various organs. Symptoms can develop gradually as the affected area swells or becomes painful. Over time, the ongoing immune attack can lead to worsening of the affected tissues. The course of the disease varies, but it typically progresses as the immune system continues to target the body.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-504280-16-00Estimated enrolment60 patientsSponsorJanssen Cilag International

sourced from the EU Clinical Trials Register and site verification

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