NCT02252809

Effect of Anti-Inflammatory Agents on Biological Responses to Endotoxin Inhalation in Healthy Subjects

An Open-Label, Parallel Group, Controlled Study in Healthy Subjects to Characterize Biological Responses to Immunological Challenges and to Measure the Effect of Marketed Anti-Inflammatory Agents on Those Responses

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Brugmann University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

Summary

The main objective of this study is to characterize the biological responses elicited by endotoxin inhalation applied to healthy subjects, and to assess the effect of standard anti-inflammatory agents (i.e. adalimumab and methylprednisolone) on these biological responses.

Detailed description

This open-label, single-center, parallel-group clinical trial is designed to evaluate Humira® or methylprednisolone versus no treatment in healthy subjects applied inhaled endotoxin challenges. A total of 30 healthy adult subjects who meet all inclusion and exclusion criteria will be randomised in a 1:1:1 ratio to one of the following cohorts: * Cohort 1 subjects receive no study drug during the study. * Cohort 2 subjects receive an oral 7-day course of the corticosteroid (methylprednisolone) during the study, starting on study Day 1. The daily dose is 20 mg. * Cohort 3 subjects receive a single subcutaneous injection of the anti-tumor necrosis factor (TNF) (adalimumab) on study Day 1, administered as a 40 mg dose. The study will include a Screening period of up to 21 days, during which subject eligibility will be assessed and Screening responses to endotoxin exposure challenge will be collected. Eligible subjects will initially undergo an 8-day treatment period, during which they will receive treatment based on their assigned cohort (or will receive no treatment if assigned to Cohort 1) and will be applied with the endotoxin challenges. After the treatment period, subjects will be followed up until study Day 42. Efficacy evaluations will include specific responses to endotoxin challenge, and effects of methylprednisolone and adalimumab on these responses. Safety will be monitored throughout the study.

Conditions

• Innate Immunity

Interventions

Type	Name	Description
DRUG	adalimumab
DRUG	methylprednisolone

Timeline

• Start date: 2008-11-01
• Primary completion: 2009-04-01
• Completion: 2009-07-01
• First posted: 2014-09-30
• Last updated: 2014-09-30