A Single Ascending Dose Study of R1671 in Patients With Mild Intermittent Asymptomatic Asthma.
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
1 other identifier
interventional
43
1 country
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 asthma
Started Oct 2007
Longer than P75 for phase_1 asthma
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 16, 2007
CompletedFirst Posted
Study publicly available on registry
August 17, 2007
CompletedStudy Start
First participant enrolled
October 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2009
CompletedNovember 2, 2016
November 1, 2016
1.8 years
August 16, 2007
November 1, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
AEs, laboratory parameters, vital signs, ECG.
Throughout study
Serum concentration of R1671, and serum pharmacokinetic parameters.
Throughout study
Secondary Outcomes (1)
Pharmacodynamic biomarker sampling; skin prick test.
At intervals during study
Study Arms (8)
1
EXPERIMENTAL2
EXPERIMENTAL3
EXPERIMENTAL4
EXPERIMENTAL5
EXPERIMENTAL6
EXPERIMENTAL7
EXPERIMENTAL8
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- adult patients, 18-50 years of age;
- mild, intermittent, asymptomatic asthma;
- history of asthma for \>=6 months;
- non-smokers.
You may not qualify if:
- females of childbearing potential, or lactating;
- history of immunologically medicated disease;
- systemic antineoplastic or immunomodulatory treatment in past 6 months.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Unknown Facility
Little Rock, Arkansas, 72204, United States
Unknown Facility
North Hollywood, California, 91606, United States
Unknown Facility
Port Orange, Florida, 32127, United States
Unknown Facility
Normal, Illinois, 61761, United States
Unknown Facility
Madisonville, Kentucky, 42431, United States
Unknown Facility
North Dartmouth, Massachusetts, 02747, United States
Unknown Facility
Morrisville, North Carolina, 27560, United States
Unknown Facility
San Antonio, Texas, 78209, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 16, 2007
First Posted
August 17, 2007
Study Start
October 1, 2007
Primary Completion
July 1, 2009
Study Completion
July 1, 2009
Last Updated
November 2, 2016
Record last verified: 2016-11