This is a study to determine the safety, pharmacodynamics (PD), and pharmacokinetics (PK) of CDX-622 in adults with mild to moderate asthma.
CDX-622 is a bispecific antibody that binds to stem cell factor (SCF) and thymic stromal lymphopoietin (TSLP). Eligible participants with mild to moderate asthma will receive a single dose of CDX-622 via IV infusion. Additional follow-up visits will be required through EOS (week 12).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Administered Intravenously
The University of Kansas Medical Center
Kansas City, Kansas, United States
RECRUITINGTo evaluate the safety and tolerability profile of CDX-622 in adults with mild to moderate asthma.
Occurrence and incidence of Treatment-Emergent Adverse Events (TEAE) and serious adverse events during the study.
Time frame: Day 1 up to Day 85 (12 weeks)
Change from baseline in fractional exhaled nitric oxide (FeNO) through week 12.
Pre-treatment and post-treatment FeNO levels will be measured at specified visits and analyzed to evaluate changes from baseline in airway inflammation.
Time frame: Day 1 up to Day 85 (12 weeks)
Change from baseline in absolute eosinophil count (AEC) through week 12.
Pre-treatment and post treatment blood samples will be collected at specified visits and analyzed for changes in AEC.
Time frame: Day 1 up to Day 85 (12 weeks)
Change from baseline through week 12 in serum biomarkers.
Pre-treatment and post-treatment blood samples will be collected at specified visits and analyzed for changes in TSLP- and SCF-related serum biomarkers.
Time frame: Day 1 up to Day 85 (12 weeks)
Pharmacokinetic (PK) evaluation from baseline through week 12.
CDX-622 serum concentrations measured at specific visits.
Time frame: Day 1 up to Day 85 (12 weeks)
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