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

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ClinicalTrials.gov Identifier: NCT00517816
Recruitment Status : Completed
First Posted : August 17, 2007
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief 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.

Condition or disease Intervention/treatment Phase
Asthma Drug: RG1671 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : October 2007
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Drug: RG1671
Administered iv at escalating doses (with a starting dose of 0.0015mg)
Experimental: 2 Drug: RG1671
Administered iv at escalating doses (with a starting dose of 0.0015mg)
Experimental: 3 Drug: RG1671
Administered iv at escalating doses (with a starting dose of 0.0015mg)
Experimental: 4 Drug: RG1671
Administered iv at escalating doses (with a starting dose of 0.0015mg)
Experimental: 5 Drug: RG1671
Administered iv at escalating doses (with a starting dose of 0.0015mg)
Experimental: 6 Drug: RG1671
Administered iv at escalating doses (with a starting dose of 0.0015mg)
Experimental: 7 Drug: RG1671
Administered iv at escalating doses (with a starting dose of 0.0015mg)
Experimental: 8 Drug: RG1671
Administered iv at escalating doses (with a starting dose of 0.0015mg)



Primary Outcome Measures :
  1. AEs, laboratory parameters, vital signs, ECG. [ Time Frame: Throughout study ]
  2. Serum concentration of R1671, and serum pharmacokinetic parameters. [ Time Frame: Throughout study ]

Secondary Outcome Measures :
  1. Pharmacodynamic biomarker sampling; skin prick test. [ Time Frame: At intervals during study ]


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00517816


Locations
United States, Arkansas
Little Rock, Arkansas, United States, 72204
United States, California
North Hollywood, California, United States, 91606
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

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00517816     History of Changes
Other Study ID Numbers: PP21029
First Posted: August 17, 2007    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016

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