This is a Phase 1, randomized, double-blind, placebo-controlled, single dose, first in human safety, tolerability, and pharmacokinetic study of SPY003-207 in healthy participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
59
Experimental
Placebo
Spyre Site 2
Cypress, California, United States
Spyre Site 1
Montreal, Quebec, Canada
Treatment emergent adverse events
Incidence, severity, and causal relationship of TEAEs
Time frame: Up to 63 weeks
Cmax
Maximum concentration after a single dose
Time frame: Up to 63 weeks
Tmax
Time to reach maximum concentration after a single dose
Time frame: Up to 63 weeks
t1/2
Half life after a single dose
Time frame: Up to 63 weeks
AUC
Area under the curve after a single dose
Time frame: Up to 63 weeks
ADA
Incidence of anti-drug antibody after a single dose
Time frame: Up to 63 weeks
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