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

Double Blind, Placebo Controlled, Parallel Group Study With an Open Label Reference Arm to Assess the Effects of Intravenously Administered AIN457 on Ozone Induced Neutrophilia Compared to Placebo & Oral Corticosteroid in Healthy Volunteers

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00920933

Enrollment

Registered

2009-06-15

Start date

2009-01-31

Completion date

Unknown

Last updated

2010-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Ozone challenge, airway neutrophilia, induced sputum, Healthy volunteers

Brief summary

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.

Interventions

BIOLOGICALAIN457

OTHERPlacebo

DRUGprednisolone

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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/

Design outcomes

Primary

Measure	Time frame
Total neutrophil cell count in 106/mL in induced sputum	Day 16

Secondary

Measure	Time frame
Serum total IL-17A	Day 1- Day 120
Percentage neutrophil cell count in induced sputum	Day 16
Safety and tolerability. Safety assessments will include vital signs, electrocardiograms (ECG), spirometry, pulse oximetry, immunogenicity and adverse events (AEs)	Day 1-Day 120
Airway function (FEV1, FVC, and FEF25-75)	4h, 24h, and 48h after the start of the ozone exposure
Serum AIN457 pharmacokinetics (PK)	Day1-Day 120

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026