The study will comprise primarily a single-ascending dose (SAD) escalation component.
Double-blind, randomized, placebo-controlled, single-dose, sequential-group design in up to 7 cohorts of healthy participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
70
Covance Clinical Research Unit Inc.
Dallas, Texas, United States
Incidence and severity of AEs
Safety and tolerability
Time frame: Approximately 5.5 weeks
Incidence of clinically significant changes in laboratory parameters, 12 lead ECG parameters, vital signs measurements, spirometry, and physical examinations
Safety and tolerability
Time frame: Approximately 5.5 weeks
Plasma PK parameters: Cmax
PK
Time frame: Approximately 5.5 weeks
Plasma PK parameters: Tmax
PK
Time frame: Approximately 5.5 weeks
Plasma PK parameters: AUC
PK
Time frame: Approximately 5.5 weeks
Urine PK parameters: Ae
PK
Time frame: Approximately 5.5 weeks
Urine PK parameters: Fe
PK
Time frame: Approximately 5.5 weeks
Urine PK parameters: CLR
PK
Time frame: Approximately 5.5 weeks
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