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

Completed · Phase 1

Conditions studied: Asthma

In brief

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.

Key facts

Study ID

NCT00517816

Run by

Hoffmann-La Roche

People needed

43

Starts

2007-10-01

Expected to finish

2009-07-01

Last updated by the study team

2016-11-02

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• adult patients, 18-50 years of age;
• mild, intermittent, asymptomatic asthma;
• history of asthma for >=6 months;
• non-smokers.

You may not qualify if…

• females of childbearing potential, or lactating;
• history of immunologically medicated disease;
• systemic antineoplastic or immunomodulatory treatment in past 6 months.

Where it is running

• Study site — Little Rock, Arkansas, United States
• Study site — North Hollywood, California, United States
• Study site — Port Orange, Florida, United States
• Study site — Normal, Illinois, United States
• Study site — Madisonville, Kentucky, United States
• Study site — North Dartmouth, Massachusetts, United States
• Study site — Morrisville, North Carolina, United States
• Study site — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.