A First-in-Human 2-part, randomized, double-blind, placebo-controlled, single ascending dose, multiple ascending dose, and food effect, investigation of the administration of PORT-77 in healthy adult participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
156
Celerion
Tempe, Arizona, United States
Number of incidence and severity of adverse events (AEs) as a measure of safety and tolerability of PORT-77 (Part I)
Time frame: Day 8
Number of incidence and severity of AEs as a measure of safety and tolerability of PORT-77 (Part II and III)
Time frame: Day 21
Plasma concentration of a single-dose of PORT-77 (Part I)
Time frame: Day 8
Plasma concentration of the steady-state of PORT-77 (Part II and III)
Time frame: Day 21
Plasma concentration of PORT-77 by effect of a standardized high-fat/high-calorie meal (Part I)
Time frame: Day 4
Evaluate effects of single doses of PORT-77 on ECG parameters (Part I)
Time frame: Day 8
Evaluate effects of multiple doses of PORT-77 on ECG parameters (Part II and III)
Time frame: Day 21
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