A 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 and oral corticosteroid in healthy volunteers
- Conditions
- Healthy volunteers
- Registration Number
- EUCTR2008-002854-39-DE
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 24
• Healthy male and female subjects age 18 to 55 years of age. Female subjects of child bearing potential will be excluded.
• Able to produce sputum with normal sputum neutrophil levels at screening (<65% of non-epithelial cells) and are ozone responsive (=50% absolute increase in sputum neutrophils at 24h, visit 3)
• Screening FEV1 at least 80% of predicted.
• Negative latent tuberculosis blood test at screening
• Able to communicate well with the investigator, to understand and comply with the requirements of the study. Understand and sign the written informed consent.
• Subjects must weigh at least 50 kg to participate in the study, and must have a body mass index (BMI) within the range of 18 to 35 kg/m2. See Appendix 3 of this protocol for BMI ranges.
Other inclusion criteria are outlined in the protocol
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
• Smokers.
• Treatment with an immunosuppressive agent within the last six months.
• Presence or history of a major chronic inflammatory autoimmune disease like psoriasis, psoriatic arthritis, rheumatoid arthritis, spondyloarthropathy, inflammatory bowel disease or systemic lupus erythematesus (SLE).
---Full inclusion / exclusion criteria are presented in the protocol---
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: • To assess the ability of AIN457 to inhibit ozone-induced airway neutrophilia (total neutrophil cell count in 106/mL) in induced sputum at 24 hours compared to placebo<br>;Primary end point(s): Total neutrophil cell count in millions/mL in induced sputum at 24 hours;Secondary Objective: • To assess the ability of AIN457 to inhibit ozone-induced airway neutrophilia in induced sputum by evaluating total neutrophil count at 24 hours compared to oral corticosteroid (OCS) and percentage neutrophil count at 24 hours compared to placebo and OCS<br>• To assess the safety and tolerability of AIN457 <br>• To evaluate the effect of AIN457 on airway function (FEV1, FVC, and FEF25-75) at 4h, 24h, and 48h after the start of the ozone exposure<br>• To evaluate the pharmacokinetics (PK) of AIN457<br>• To evaluate the pharmacodynamics (PD) of AIN457 as reflected in serum total IL-17A<br>
- Secondary Outcome Measures
Name Time Method