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

Sponsor
Janssen Research & Development, LLC
Study ID
NCT04973566
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

  • Nipocalimab — DRUG
    Nipocalimab will be administered as an IV infusion.
  • Etanercept — DRUG
    Etanercept will be administered subcutaneously.
  • Hydroxychloroquine — DRUG
    HCQ will be administered orally.

Study Details

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.

Key Dates

Start date
Aug 31, 2021
Status verified
Mar 2025
Primary completion
May 27, 2022
Completion
May 27, 2022

Study Design

Enrollment
48 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: 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.
  • Experimental: Part 2 (Cohort 1): Nipocalimab
    Participants will receive a single IV infusion of nipocalimab on Day 1 in Cohort 1 of Part 2.
  • Experimental: 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.

Primary Outcome Measure

Part 1: Serum Etanercept Concentration [ Time Frame: Up to Day 99 ]

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