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NCT00517816 · ClinicalTrials.gov registry record · Phase 1
A Single Ascending Dose Study of R1671 in Patients With Mild Intermittent Asymptomatic Asthma.
A Phase 1 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 1
- Development phase
- 43
- Enrollment target
NCT00517816 is a Phase 1 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 43 participants.
The verdict
NCT00517816, a Phase 1 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 43 participants
- Enrollment target
Study 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.
Interventions
- DRUG RG1671
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2007-10 |
| Est. Completion | 2009-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00517816
The ClinicalTrials.gov registry entry for NCT00517816 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 43 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which RG1671 is the first listed.
NCT00517816 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00517816 about?
NCT00517816 is a clinical study titled "A Single Ascending Dose Study 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 intraveno...
What is the current status of trial NCT00517816?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 43 participants. The study started on 2007-10. Estimated completion is 2009-07.
What interventions are being tested in trial NCT00517816?
The interventions under investigation include: RG1671 (DRUG).
Who is sponsoring clinical trial NCT00517816?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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