A Study of Nipocalimab in Healthy Male and Female Participants

Sponsor
Janssen Research & Development, LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT04848558
Collaborator
(none)
89
1
2
12
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Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
89 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Other
Official 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
Actual Study Start Date :
May 25, 2021
Actual Primary Completion Date :
May 26, 2022
Actual Study Completion Date :
May 26, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Part 1: Single Dose Cohorts

Participants will receive subcutaneous (SC) injection or intravenous (IV) infusion of nipocalimab or placebo in single ascending doses on Day 1 in Cohorts 1-6 and SC administration in optional Cohorts 7-8.

Drug: Nipocalimab
Participants will receive IV infusion or SC injection of nipocalimab.
Other Names:
  • JNJ-80202135
  • Other: Placebo
    Participants will receive IV infusion or SC injection of placebo.

    Experimental: Part 2: Multiple Dose Cohorts

    Participants will receive up to 4 weekly SC injections of nipocalimab or placebo on Days 1, 8, 15, and 22 in Cohort 1 or 4 biweekly SC injections on Days 1, 15, 29, and 43 in optional Cohort 2.

    Drug: Nipocalimab
    Participants will receive IV infusion or SC injection of nipocalimab.
    Other Names:
  • JNJ-80202135
  • Other: Placebo
    Participants will receive IV infusion or SC injection of placebo.

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants with Adverse Events (AEs) [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) [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 [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 [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) [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 [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 [Up to Day 85]

      Number of participants with ECG abnormalities will be reported.

    8. Number of Participants with Clinical Laboratory Abnormalities [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 [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 Outcome Measures

    1. Serum Concentration of Nipocalimab [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 [Baseline to Day 85]

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

    3. Number of Participants with Antibodies to Nipocalimab [Up to Day 85]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 PRA Health Sciences Groningen Netherlands NZ 9728

    Sponsors and Collaborators

    • Janssen Research & Development, LLC

    Investigators

    • Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Janssen Research & Development, LLC
    ClinicalTrials.gov Identifier:
    NCT04848558
    Other Study ID Numbers:
    • CR108993
    • 2020-005892-10
    • 80202135EDI1001
    First Posted:
    Apr 19, 2021
    Last Update Posted:
    Jul 6, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Jul 6, 2022