A Single Ascending Dose Study of R1671 in Patients With Mild Intermittent Asymptomatic Asthma. - Full Text View

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00517816

Purpose

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.

Condition	Intervention	Phase
Asthma	Drug: R1671	Phase I

MedlinePlus related topics: Asthma

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety Study
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

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

AEs, laboratory parameters, vital signs, ECG. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Serum concentration of R1671, and serum pharmacokinetic parameters. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Pharmacodynamic biomarker sampling; skin prick test. [ Time Frame: At intervals during study ] [ Designated as safety issue: No ]

Estimated Enrollment:	64
Study Start Date:	October 2007
Estimated Study Completion Date:	November 2009

Arms	Assigned Interventions
1: Experimental	Drug: R1671 Administered iv at escalating doses (with a starting dose of 0.0015mg)
2: Experimental	Drug: R1671 Administered iv at escalating doses (with a starting dose of 0.0015mg)
3: Experimental	Drug: R1671 Administered iv at escalating doses (with a starting dose of 0.0015mg)
4: Experimental	Drug: R1671 Administered iv at escalating doses (with a starting dose of 0.0015mg)
5: Experimental	Drug: R1671 Administered iv at escalating doses (with a starting dose of 0.0015mg)
6: Experimental	Drug: R1671 Administered iv at escalating doses (with a starting dose of 0.0015mg)
7: Experimental	Drug: R1671 Administered iv at escalating doses (with a starting dose of 0.0015mg)
8: Experimental	Drug: R1671 Administered iv at escalating doses (with a starting dose of 0.0015mg)

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00517816

Contacts

Contact: Please reference Study ID Number: PP21029	973-235-5000
Contact: or	800-526-6367 (FOR US ONLY)

Locations

United States, Arkansas
	Recruiting
LITTLE ROCK, Arkansas, United States, 72202
United States, California
	Completed
BURBANK, California, United States, 91505
United States, Florida
	Active, not recruiting
PORT ORANGE, Florida, United States, 32127
United States, Illinois
	Recruiting
NORMAL, Illinois, United States, 61761
United States, Kentucky
	Recruiting
MADISONVILLE, Kentucky, United States, 42431
United States, Massachusetts
	Recruiting
NORTH DARTMOUTH, Massachusetts, United States, 02745
United States, North Carolina
	Terminated
MORRISVILLE, North Carolina, United States, 27560
United States, Texas
	Terminated
SAN ANTONIO, Texas, United States, 78209

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

More Information

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	PP21029
Study First Received:	August 16, 2007
Last Updated:	January 15, 2009
ClinicalTrials.gov Identifier:	NCT00517816
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases

Hypersensitivity, Immediate
Asthma
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Immune System Diseases
Bronchial Diseases

ClinicalTrials.gov processed this record on January 16, 2009