Effect of Anti-Inflammatory Agents on Biological Responses to Endotoxin Inhalation in Healthy Subjects
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|ClinicalTrials.gov Identifier: NCT02252809|
Recruitment Status : Completed
First Posted : September 30, 2014
Last Update Posted : September 30, 2014
|Condition or disease||Intervention/treatment||Phase|
|Innate Immunity||Drug: adalimumab Drug: methylprednisolone||Early Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||51 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||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|
|Study Start Date :||November 2008|
|Actual Primary Completion Date :||April 2009|
|Actual Study Completion Date :||July 2009|
Active Comparator: adalimumab
adalimumab 40 mg by subcutaneous way 7 days before endotoxin inhalation
Active Comparator: methylprednisolone
methylprednisolone 20 mg daily , 7 days before endotoxin inhalation
No Intervention: control
no intervention, 7 days before endotoxin inhalation
- sputum cells count [ Time Frame: 7 days ]