A Study of JNJ-80202135 in Healthy Chinese Adult Participants

Sponsor
Janssen Research & Development, LLC
Study ID
NCT05151692
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Nipocalimab — DRUG
    Nipocalimab will be administered as an IV infusion.

Study Details

The purpose of this study is to assess the pharmacokinetic (PK) of nipocalimab following single intravenous (IV) administration in healthy Chinese participants.

Key Dates

Start date
May 30, 2022
Status verified
Oct 2022
Primary completion
Sep 9, 2022
Completion
Sep 9, 2022

Study Design

Enrollment
30 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Cohort 1: Nipocalimab
    Participants will receive a single intravenous (IV) dose of nipocalimab Dose 1 on Day 1.
  • Experimental: Cohort 2: Nipocalimab
    Participants will receive a single IV dose of nipocalimab Dose 2 on Day 1.
  • Experimental: Cohort 3: Nipocalimab
    Participants will receive a single IV dose of nipocalimab Dose 3 on Day 1.

Primary Outcome Measure

Area Under the Serum Concentration Versus Time Curve From Time Zero to Time of the Last Measurable Concentration (AUC[0-last]) of Nipocalimab [ Time Frame: Up to Day 29 ]

Related Studies