A Study of Nipocalimab in Healthy Male and Female Participants

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Nipocalimab; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 89
• Phase: Phase 1

Contacts and Locations

Study Locations

• Netherlands
  • Groningen, Netherlands, NZ 9728
    • PRA Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to Day 85
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.	Up to Day 85
Percentage of Participants with Reasonably Related AEs	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.	Up to Day 85
Percentage of Participants with AEs Leading to Discontinuation of Study Intervention	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.	Up to Day 85
Percentage of Participants with Adverse Events of Special Interest (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 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.	Up to Day 85
Number of Participants with Vital Signs Abnormalities	Number of participants with vital signs abnormalities including body temperature, pulse/heart rate, respiratory rate, blood pressure will be reported.	Up to Day 85
Number of Participants with Electrocardiogram (ECG) Abnormalities	Number of participants with ECG abnormalities will be reported.	Up to Day 85
Number of Participants with Clinical Laboratory Abnormalities	Number of participants with clinical laboratory abnormalities related to hematology, serum chemistry and urinalysis will be reported.	Up to Day 85
Number of Participants with Subcutaneous (SC) Injection-site Reactions	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.	Up to Day 85

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum Concentration of Nipocalimab	Serum samples will be analyzed to determine concentrations of nipocalimab using a validated, specific, and sensitive immunoassay method.	Up to Day 85
Change from Baseline in Immunoglobulin (Ig) Levels Over Time	Change from baseline in Ig levels over time will be reported.	Baseline to Day 85
Number of Participants with Antibodies to Nipocalimab	Number of participants with anti-drug antibodies to nipocalimab will be reported.	Up to Day 85

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2021
• Primary Completion (Actual): May 26, 2022
• Study Completion (Actual): May 26, 2022

Study Registration Dates

• First Submitted: April 14, 2021
• First Submitted That Met QC Criteria: April 14, 2021
• First Posted (Actual): April 19, 2021

Study Record Updates

• Last Update Posted (Actual): July 3, 2023
• Last Update Submitted That Met QC Criteria: June 30, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: CR108993; 2020-005892-10 (EudraCT Number); 80202135EDI1001 (Other Identifier: Janssen Research & Development, LLC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinicaltrials/ 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No