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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: Completed Phase 1 study, sponsored by Hoffmann-La Roche.

NCT00517816 is a Phase 1 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 43 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (28% lower). According to ClinicalTrials.gov, the official US trial registry.

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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

FieldValue
Enrollment Target 43 participants
Start Date 2007-10
Est. Completion 2009-07
Phase Phase 1
Hoffmann-La Roche

909 total trials

What the finished NCT00517816 record still lists

NCT00517816 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (28% lower).

The record links to 0 conditions, and to 1 intervention - of which RG1671 is the first listed.

NCT00517816 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT00517816's enrollment target sits among peer trials

43 1100th of 2000 higher than 896 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00517816, the US trial registry maintained by the National Library of Medicine. NCT00517816 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.