A Study of Nipocalimab in Healthy Male and Female Participants

NCT04848558 | Completed Phase 1

• 3 other identifiers: CR1089932020-005892-1080202135EDI1001
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (3)

• Serum Concentration of Nipocalimab

  Up to Day 85

• Change from Baseline in Immunoglobulin (Ig) Levels Over Time

  Baseline to Day 85

• Number of Participants with Antibodies to Nipocalimab

  Up to Day 85

Study Arms (2)

Part 1: Single Dose Cohorts

EXPERIMENTAL

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; Other: Placebo

Part 2: Multiple Dose Cohorts

EXPERIMENTAL

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; Other: Placebo

Interventions

Nipocalimab DRUG

Participants will receive IV infusion or SC injection of nipocalimab.

Also known as: JNJ-80202135

Part 1: Single Dose Cohorts; Part 2: Multiple Dose Cohorts

Placebo OTHER

Participants will receive IV infusion or SC injection of placebo.

Part 1: Single Dose Cohorts; Part 2: Multiple Dose Cohorts

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (1)

PRA Health Sciences

Groningen, NZ 9728, Netherlands

Location

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2021
• First Posted: April 19, 2021
• Study Start: May 25, 2021
• Primary Completion: May 26, 2022
• Study Completion: May 26, 2022
• Last Updated: July 3, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share

Locations

NL (1)