Healthy volunteers
Conditions
Interventions
Product Code: AIN457
Pharmaceutical Form: Powder for solution for infusion
Current Sponsor code: AIN457
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmace
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 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 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • 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---
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 ;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 • To assess the safety and tolerability of AIN457 • 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 • To evaluate the pharmacokinetics (PK) of AIN457 • To evaluate the pharmacodynamics (PD) of AIN457 as reflected in serum total IL-17A | — |
Countries
Germany
Outcome results
None listed