A Single Ascending Dose Study of R1671 in Patients With Mild Intermittent Asymptomatic Asthma.
- Registration Number
- NCT00517816
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This 8 arm study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending doses of R1671 or placebo in patients with mild, intermittent, asymptomatic asthma. Patients will be randomized to receive placebo or R1671, at a starting dose of 0.0015mg, by intravenous infusion; this dose will be escalated in subsequent groups of patients after a satisfactory assessment of the data from the previous dose. The anticipated time on study treatment is \<3 months, and the target sample size is \<100 individuals.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 43
Inclusion Criteria
- adult patients, 18-50 years of age;
- mild, intermittent, asymptomatic asthma;
- history of asthma for >=6 months;
- non-smokers.
Exclusion Criteria
- females of childbearing potential, or lactating;
- history of immunologically medicated disease;
- systemic antineoplastic or immunomodulatory treatment in past 6 months.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 3 RG1671 - 5 RG1671 - 7 RG1671 - 2 RG1671 - 6 RG1671 - 4 RG1671 - 1 RG1671 - 8 RG1671 -
- Primary Outcome Measures
Name Time Method AEs, laboratory parameters, vital signs, ECG. Throughout study Serum concentration of R1671, and serum pharmacokinetic parameters. Throughout study
- Secondary Outcome Measures
Name Time Method Pharmacodynamic biomarker sampling; skin prick test. At intervals during study