A Single Ascending Dose Study of R1671 in Patients With Mild Intermittent Asymptomatic Asthma.
| Status: | Completed |
|---|---|
| Conditions: | Asthma |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 50 |
| Updated: | 8/3/2016 |
| Start Date: | October 2007 |
| End Date: | July 2009 |
A Randomized, Double-blind, Single Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics and Effect on Pharmacodynamic Biomarkers of an Intravenous Infusion of R1671 in Patients With Mild, Intermittent Asymptomatic Asthma
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.
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.
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.
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