drugset / Trial / NCT00517816

A Single Ascending Dose Study of R1671 in Patients With Mild Intermittent Asymptomatic Asthma.

NCT00517816 ↗

Phase 1 Completed 43 enrolled Hoffmann-La Roche
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2007-10
Primary completion
2009-07
Completion
2009-07

Drugs

EvaluationDrugModalityDoseRoute
Subject RG1671 Unknown 0.0015 mg Intravenous

Indications