A Study of Nipocalimab in Healthy Male and Female Participants

Sponsor
Janssen Research & Development, LLC
Study ID
NCT04848558
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

  • Nipocalimab — DRUG
    Participants will receive IV infusion or SC injection of nipocalimab.
  • Placebo — OTHER
    Participants will receive IV infusion or SC injection of placebo.

Study Details

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.

Key Dates

Start date
May 25, 2021
Status verified
Jun 2023
Primary completion
May 26, 2022
Completion
May 26, 2022

Study Design

Enrollment
89 participants (actual)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER

Arms

  • 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.
  • 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.

Primary Outcome Measure

Percentage of Participants with Adverse Events (AEs) [ Time Frame: Up to Day 85 ]

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