The primary purpose of this study is to evaluate the safety and tolerability of single and multiple doses of treprostinil palmitil inhalation powder in healthy participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
42
Oral inhalation using a Plastiape capsule-based dry powder inhaler.
Oral placebo inhalation using a Plastiape capsule-based dry powder inhaler.
USA001
Austin, Texas, United States
Parts A and B: Number of Participants who Experienced an Adverse Event (AE)
Safety and tolerability of single and multiple doses of treprostinil inhalation powder will be determined in healthy participants.
Time frame: Up to Day 31 in Part A and Day 37 in Part B
Parts A and B: Area Under the Plasma Concentration Versus Time Curve (AUC) of Treprostinil
Pharmacokinetics of treprostinil following a single and multiple doses will be assessed in healthy participants.
Time frame: Part A: Predose and at multiple time points postdose up to Day 4; Part B: Predose and at multiple time points postdose up to Day 10
Parts A and B: Area Under the Plasma Concentration Versus Time Curve (AUC) of Treprostinil Palmitil
Pharmacokinetics of treprostinil palmitil following a single and multiple doses will be assessed in healthy participants.
Time frame: Part A: Predose and at multiple time points postdose up to Day 4; Part B: Predose and at multiple time points postdose up to Day 10
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