Ignite Creation Date:
2024-05-05 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00517816
Status:
COMPLETED
Last Update Posted:
2016-11-02
First Post:
2007-08-16
Brief Title:
A Single Ascending Dose Study of R1671 in Patients With Mild Intermittent Asymptomatic Asthma
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2016-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 00015mg 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None