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Completed

NCT Number: NCT04848558

A Study of Nipocalimab in Healthy Male and Female Participants

The purpose of this study is to evaluate the safety and tolerability of single and multiple doses of nipocalimab following subcutaneous (SC) administration compared with intravenous (IV) administration in healthy participants.

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Key information

Conditions

Healthy

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

PRA Health Sciences

Groningen, NZ 9728, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening
  • Healthy on the basis of clinical laboratory tests performed at screening
  • Continuous non-smoker
  • A woman of childbearing potential must have a negative pregnancy test
  • It is recommended that participants are up to date on all age appropriate vaccinations prior to screening as per routine local medical guidelines

Exclusion criteria

  • Has a history of liver or renal insufficiency; cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
  • Currently has a malignancy or has a history of malignancy within 3 years before screening
  • Known allergies, hypersensitivity, or intolerance to nipocalimab or its excipients
  • Has received a live vaccine within 3 months prior to screening or has a known need to receive a live vaccine during the study, or within at least 3 months after the last administration of study intervention in this study
  • Shows evidence of an active or chronic hepatitis B infection

Treatment and study plan

Nipocalimab

Drug

Participants will receive IV infusion or SC injection of nipocalimab.

Other names: JNJ-80202135

Placebo

Other

Participants will receive IV infusion or SC injection of placebo.

Primary outcomes

  1. Percentage of Participants with Adverse Events (AEs)

    Time frame: Up to Day 85

    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.

  2. Percentage of Participants with Serious Adverse Event (SAE)

    Time frame: Up to Day 85

    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.

  3. Percentage of Participants with Reasonably Related AEs

    Time frame: Up to Day 85

    Percentage of participants with reasonably related AEs will be reported. Reasonably related AE is an AE that has a casual relationship with the pharmaceutical/biological agent under study.

  4. Percentage of Participants with AEs Leading to Discontinuation of Study Intervention

    Time frame: Up to Day 85

    Percentage of participants with AEs leading to discontinuation of study intervention will be reported. The participants were discontinued from the study by the investigator if the safety reasons or tolerability reasons such as an AE, it is in the best interest of the participant to discontinue study intervention.

  5. Percentage of Participants with Adverse Events of Special Interest (AESIs)

    Time frame: Up to Day 85

    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 intravenous (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). Treatment-emergent AEs are defined as AEs with onset or worsening on or after date of first dose of study treatment.

  6. Number of Participants with Vital Signs Abnormalities

    Time frame: Up to Day 85

    Number of participants with vital signs abnormalities including body temperature, pulse/heart rate, respiratory rate, blood pressure will be reported.

  7. Number of Participants with Electrocardiogram (ECG) Abnormalities

    Time frame: Up to Day 85

    Number of participants with ECG abnormalities will be reported.

  8. Number of Participants with Clinical Laboratory Abnormalities

    Time frame: Up to Day 85

    Number of participants with clinical laboratory abnormalities related to hematology, serum chemistry and urinalysis will be reported.

  9. Number of Participants with Subcutaneous (SC) Injection-site Reactions

    Time frame: Up to Day 85

    Number of participants with SC injection-site reactions will be reported. An injection-site reaction is any AE at a SC study intervention injection-site.

Secondary outcomes

  1. Serum Concentration of Nipocalimab

    Time frame: Up to Day 85

    Serum samples will be analyzed to determine concentrations of nipocalimab using a validated, specific, and sensitive immunoassay method.

  2. Change from Baseline in Immunoglobulin (Ig) Levels Over Time

    Time frame: Baseline to Day 85

    Change from baseline in Ig levels over time will be reported.

  3. Number of Participants with Antibodies to Nipocalimab

    Time frame: Up to Day 85

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

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study title

A Phase 1 Double-Blind, Placebo-Controlled, Single- and Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous Nipocalimab in Healthy Male and Female Participants

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 19, 2021
Registry last updated
Jul 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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