This study is testing the safety, tolerability, pharmacokinetics and pharmacodynamics of GB-0895.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
156
Single subcutaneous dose of GB-0895
Multiple subcutaneous doses of GB-0895
Single subcutaneous dose of placebo
Alcanza
DeLand, Florida, United States
Miami Research Institute of South Florida
Miami, Florida, United States
Omega Research
Orlando, Florida, United States
Number of participants with treatment related adverse events as assessed by CTCAE 5.0
Time frame: Day 1 to Day 500
Measure of maximum plasma concentration of GB-0895
Time frame: Day 1 to Day 500
Total exposure of GB-0895 (AUC)
Time frame: Day 1 to Day 500
Blood eosinophil counts
Time frame: Day 1 to Day 500
Incidence of treatment-emergent anti-drug antibody (ADA) response
Time frame: Day 1 to Day 500
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Multiple subcutaneous doses of placebo
Nucleus Network
Saint Paul, Minnesota, United States
Southeastern Research Center
Winston-Salem, North Carolina, United States
DM Clinical Research
Tomball, Texas, United States
Charite Research Organization GmbH
Berlin, Germany
IKF Pneumologie
Frankfurt, Germany
Fraunhofer Institut fur Toxikologie and Experimentelle Medizin (ITEM)
Hanover, Germany
Hammersmith Medicines Research
London, United Kingdom
...and 3 more locations