A Study of Adalimumab on Inflammatory Mediators Following a Systemic Endotoxin Challenge

Sponsor
Janssen Research & Development, LLC
Study ID
NCT05884242
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Adalimumab — DRUG
    Adalimumab will be administered subcutaneously.
  • Lipopolysaccharide (LPS) — DRUG
    LPS will be administered intravenously.

Study Details

The purpose of the study is to characterize the inflammatory response to lipopolysaccharide (LPS; molecules that contains fats and carbohydrates) in the presence of a targeted immune pathway modulator.

Key Dates

Start date
May 22, 2023
Status verified
Mar 2025
Primary completion
Aug 1, 2023
Completion
Aug 7, 2023

Study Design

Enrollment
20 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Active Arm: Adalimumab + Lipopolysaccharide (LPS) Challenge
    Healthy participants will receive adalimumab subcutaneous (SC) injections via prefilled syringe or prefilled pen on Day 1, followed by the LPS intravenous (IV) injection challenge on Day 6.
  • Experimental: Control Arm: LPS Challenge
    Participants will receive LPS IV injection on Day 6. No study interaction will be administered.

Primary Outcome Measure

Change From Baseline in C-reactive Protein (CRP) [ Time Frame: From baseline up to Day 14 ]

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