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

This study has been completed.
Sponsor:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00517816
First received: August 16, 2007
Last updated: October 15, 2009
Last verified: October 2009
History of Changes
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Asthma
U.S. FDA Resources

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 ]

Enrollment: 43
Study Completion Date: July 2009
Arms Assigned Interventions
Experimental: 1 Drug: R1671
Administered iv at escalating doses (with a starting dose of 0.0015mg)
Experimental: 2 Drug: R1671
Administered iv at escalating doses (with a starting dose of 0.0015mg)
Experimental: 3 Drug: R1671
Administered iv at escalating doses (with a starting dose of 0.0015mg)
Experimental: 4 Drug: R1671
Administered iv at escalating doses (with a starting dose of 0.0015mg)
Experimental: 5 Drug: R1671
Administered iv at escalating doses (with a starting dose of 0.0015mg)
Experimental: 6 Drug: R1671
Administered iv at escalating doses (with a starting dose of 0.0015mg)
Experimental: 7 Drug: R1671
Administered iv at escalating doses (with a starting dose of 0.0015mg)
Experimental: 8 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

Locations
United States, Arkansas
Little Rock, Arkansas, United States, 72202
United States, California
Burbank, California, United States, 91505
United States, Florida
Port Orange, Florida, United States, 32127
United States, Illinois
Normal, Illinois, United States, 61761
United States, Kentucky
Madisonville, Kentucky, United States, 42431
United States, Massachusetts
North Dartmouth, Massachusetts, United States, 02747
United States, North Carolina
Morrisville, North Carolina, United States, 27560
United States, Texas
San Antonio, Texas, United States, 78209
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00517816     History of Changes
Other Study ID Numbers: PP21029
Study First Received: August 16, 2007
Last Updated: October 15, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
 Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on May 22, 2013