A Study of Nipocalimab With Co-administration of Etanercept or Hydroxychloroquine in Healthy Participants

NCT ID: NCT04973566

Last Updated: 2025-03-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-31
• Study Completion Date: 2022-05-27

Brief Summary

The primary purpose of this study is to assess the effect of nipocalimab on the pharmacokinetic (PK) of etanercept (Part 1); and to assess the effect of hydroxychloroquine (HCQ) on total serum immunoglobin G (IgG) reduction by nipocalimab (Part 2) in healthy participants.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Part 1: Etanercept and Nipocalimab

Participants will receive a single subcutaneous (SC) dose of etanercept on Day 1 in Period 1 followed by single intravenous (IV) infusion of nipocalimab on Day 29, SC administration of etanercept followed by an IV infusion of nipocalimab on Day 43 and then a single dose of nipocalimab IV infusion on Day 57 in Period 2 of Part 1. There will be a wash-out period of 28 days between Day 1 of Period 1 and Day 29 of Period 2 in Part 1.

Group Type: EXPERIMENTAL

Nipocalimab

Intervention Type: DRUG

Nipocalimab will be administered as an IV infusion.

Etanercept

Intervention Type: DRUG

Etanercept will be administered subcutaneously.

Part 2 (Cohort 1): Nipocalimab

Participants will receive a single IV infusion of nipocalimab on Day 1 in Cohort 1 of Part 2.

Group Type: EXPERIMENTAL

Nipocalimab

Intervention Type: DRUG

Nipocalimab will be administered as an IV infusion.

Part 2 (Cohort 2): Nipocalimab and Hydroxychloroquine (HCQ)

Participants will receive a single oral dose of HCQ film-coated tablets once daily from Day 1 to Day 22 and a single IV infusion of nipocalimab on Day 8 in Cohort 2 of Part 2.

Group Type: EXPERIMENTAL

Nipocalimab

Intervention Type: DRUG

Nipocalimab will be administered as an IV infusion.

Hydroxychloroquine

Intervention Type: DRUG

HCQ will be administered orally.

Interventions

Nipocalimab

Nipocalimab will be administered as an IV infusion.

Intervention Type: DRUG

Etanercept

Etanercept will be administered subcutaneously.

Intervention Type: DRUG

Hydroxychloroquine

HCQ will be administered orally.

Intervention Type: DRUG

Other Intervention Names

JNJ-80202135, M281

Eligibility Criteria

Inclusion Criteria

• Healthy based on physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening. If there are any abnormalities, they must be consistent with the underlying illness in the study population or considered not clinically relevant and this determination must be recorded in the participant's source documents and initialed by the investigator
• Healthy on the basis of clinical laboratory tests performed at screening (including immunoglobulin [Ig]G) and at admission to the study site. If the results of the serum chemistry panel, liver panel, hematology, or urinalysis are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator
• Good venous access in both arms
• Participants must have heart rate of at least 50 beats per minute
• Participant is considered eligible according to the following tuberculosis (TB) screening criteria (for Part 1 only): a) have no history of latent or active TB before screening; b) have no signs or symptoms suggestive of active TB upon medical history and/or physical examination; c) have had no recent close contact with a person with active TB; d) have a negative QuantiFERON-TB test result within 28 days prior to the administration of study intervention
• Part 1: Body mass index (BMI) greater than or equal to (>=) 18.0 to less than or equal to (<=) 30.0 kilogram (kg)/meter (m)^2 (inclusive), and body weight >= 50 to <= 110.0 kg (inclusive) at the screening visit and on Day -1; Part 2: BMI >= 18.0 to <= 30.0 kg/m^2 (inclusive), and body weight >= 61.5 to <= 110.0 kg (inclusive) at the screening visit and on Day -1
• A female participant must have a negative serum (beta-human chorionic gonadotropin) test at screening and a urine pregnancy test at Day -1 prior to administration of study intervention
• It is recommended that participants are up to date on age-appropriate vaccinations prior to screening per routine local medical guidelines. For study participants who received locally-approved (and including emergency use-authorized) coronavirus disease 2019 (COVID-19) vaccines recently prior to study entry, applicable local vaccine labeling, guidelines, and standards of care for participants receiving immune-targeted therapy should be followed when determining an appropriate interval between vaccination and study enrollment

Exclusion Criteria

• Has a history of liver or renal insufficiency; cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
• Has a history of retinal and macular disease (only for Part 2)
• Has shown a previous severe immediate hypersensitivity reaction response, including anaphylaxis, to therapeutic proteins (example, monoclonal antibody [mAbs])
• Has serum albumin levels < 30 grams/Liter (g/L) at screening and Day -1
• Has a history of myocardial infarction, unstable ischemic heart disease, or stroke within 12 weeks prior to screening

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

PRA Health Sciences

Groningen, , Netherlands

Countries

Netherlands

Other Identifiers

2021-001656-33

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

80202135EDI1003

Identifier Type: OTHER

Identifier Source: secondary_id

CR109053

Identifier Type: -

Identifier Source: org_study_id