Effect of AIN457 on Ozone-induced Airway Neutrophilia Compared to Placebo and Corticosteroid in Healthy Subjects

Phase 2CompletedNCT00920933

Novartis Pharmaceuticals24 enrolled

Overview

This study will assess the ability of AIN457 to attenuate the increase in airway neutrophils that is seen following ozone exposure. Healthy subjects will be treated with AIN457, placebo, or oral corticosteroid and the response to a subsequent ozone exposure will be evaluated.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Healthy

Interventions

AIN457BIOLOGICAL

PlaceboOTHER

prednisoloneDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion criteria: * Healthy subjects * Normal sputum neutrophil levels at screening * Ozone responsive Exclusion criteria: * Smokers * Prior treatment with antibody treatment or immunosuppressive agent * Presence or history of a major chronic inflammatory autoimmune disease * History of severe hypersensitivity to any biological agents (antibody or soluble receptor), a history of serious allergic reaction, collagen disease, neurological disease (including demyelinating disease). Other protocol-defined inclusion/exclusion criteria may apply

Locations (1)

Novartis Investigative Site

Großhansdorf, Germany

Outcomes

Primary Outcomes

Total neutrophil cell count in 106/mL in induced sputum

Time frame: Day 16

Secondary Outcomes

Serum total IL-17A

Time frame: Day 1- Day 120

Percentage neutrophil cell count in induced sputum

Time frame: Day 16

Safety and tolerability. Safety assessments will include vital signs, electrocardiograms (ECG), spirometry, pulse oximetry, immunogenicity and adverse events (AEs)

Time frame: Day 1-Day 120

Airway function (FEV1, FVC, and FEF25-75)

Time frame: 4h, 24h, and 48h after the start of the ozone exposure

Serum AIN457 pharmacokinetics (PK)

Time frame: Day1-Day 120

Data from ClinicalTrials.gov

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