MedDataX Logo

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

NCT ID: NCT00517816

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2009-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Asthma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Group Type EXPERIMENTAL

RG1671

Intervention Type DRUG

Administered iv at escalating doses (with a starting dose of 0.0015mg)

2

Group Type EXPERIMENTAL

RG1671

Intervention Type DRUG

Administered iv at escalating doses (with a starting dose of 0.0015mg)

3

Group Type EXPERIMENTAL

RG1671

Intervention Type DRUG

Administered iv at escalating doses (with a starting dose of 0.0015mg)

4

Group Type EXPERIMENTAL

RG1671

Intervention Type DRUG

Administered iv at escalating doses (with a starting dose of 0.0015mg)

5

Group Type EXPERIMENTAL

RG1671

Intervention Type DRUG

Administered iv at escalating doses (with a starting dose of 0.0015mg)

6

Group Type EXPERIMENTAL

RG1671

Intervention Type DRUG

Administered iv at escalating doses (with a starting dose of 0.0015mg)

7

Group Type EXPERIMENTAL

RG1671

Intervention Type DRUG

Administered iv at escalating doses (with a starting dose of 0.0015mg)

8

Group Type EXPERIMENTAL

RG1671

Intervention Type DRUG

Administered iv at escalating doses (with a starting dose of 0.0015mg)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

RG1671

Administered iv at escalating doses (with a starting dose of 0.0015mg)

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Little Rock, Arkansas, United States

Site Status

North Hollywood, California, United States

Site Status

Port Orange, Florida, United States

Site Status

Normal, Illinois, United States

Site Status

Madisonville, Kentucky, United States

Site Status

North Dartmouth, Massachusetts, United States

Site Status

Morrisville, North Carolina, United States

Site Status

San Antonio, Texas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PP21029

Identifier Type: -

Identifier Source: org_study_id