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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
43
Administered iv at escalating doses (with a starting dose of 0.0015mg)
Unnamed facility
Little Rock, Arkansas, United States
Unnamed facility
North Hollywood, California, United States
Unnamed facility
Port Orange, Florida, United States
Unnamed facility
Normal, Illinois, United States
AEs, laboratory parameters, vital signs, ECG.
Time frame: Throughout study
Serum concentration of R1671, and serum pharmacokinetic parameters.
Time frame: Throughout study
Pharmacodynamic biomarker sampling; skin prick test.
Time frame: At intervals during study
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Unnamed facility
Madisonville, Kentucky, United States
Unnamed facility
North Dartmouth, Massachusetts, United States
Unnamed facility
Morrisville, North Carolina, United States
Unnamed facility
San Antonio, Texas, United States