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Completed

NCT Number: NCT00920933

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

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.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Novartis Investigative Site

Großhansdorf, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AIN457

Biological

Placebo

Other

Prednisolone

Drug

Primary outcomes

  1. Total neutrophil cell count in 106/mL in induced sputum

    Time frame: Day 16

Secondary outcomes

  1. Serum total IL-17A

    Time frame: Day 1- Day 120

  2. Percentage neutrophil cell count in induced sputum

    Time frame: Day 16

  3. 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

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

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

  5. Serum AIN457 pharmacokinetics (PK)

    Time frame: Day1-Day 120

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
First posted
Jun 15, 2009
Registry last updated
Apr 9, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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