Safety, Tolerability, and Pharmacokinetics of Treprostinil Palmitil Inhalation Powder for Pulmonary Hypertension: A Phase 1, Randomized, Double-Blind, Single- and Multiple-Dose Study

Table 2 Safety summary (safety population)

n (%)	TPIP single-dose groups (n = 26)					TPIP multiple-dose groups (n = 16)
n (%)	112.5 µg (n = 6)	225 µg (n = 6)	450 µg (n = 6)	675 µg (n = 6)	Placebo (n = 2)	225 µg QD (n = 6)	112.5 µg QD + 225 µg QD (n = 6)	Placebo (n = 4)
Any TEAE	4 (66.7)	3 (50.0)	4 (66.7)	6 (100.0)	0	6 (100.0)	4 (66.7)	2 (50.0)
Moderate TEAE	0	1 (16.7)	0	3 (50.0)	0	3 (50.0)	0	0
Severe TEAE	0	0	0	0	0	0	0	0
Serious TEAE	0	0	0	0	0	0	0	0
TEAE leading to discontinuation	0	0	0	0	0	1 (16.7)	0	0
Death	0	0	0	0	0	0	0	0
TEAEs in ≥ 2 participants in any treatment group
Cough	2 (33.3)	2 (33.3)	3 (50.0)	4 (66.7)	0	6 (100.0)	1 (16.7)	2 (50.0)
Dizziness	1 (16.7)	1 (16.7)	2 (33.3)	3 (50.0)	0	2 (33.3)	1 (16.7)	0
Headache	0	0	1 (16.7)	1 (16.7)	0	4 (66.7)	2 (33.3)	0
Nausea	0	1 (16.7)	2 (33.3)	1 (16.7)	0	3 (50.0)	1 (16.7)	0
Chest discomfort	1 (16.7)	0	1 (16.7)	1 (16.7)	0	2 (33.3)	2 (33.3)	0
Throat irritation	2 (33.3)	2 (33.3)	1 (16.7)	0	0	1 (16.7)	0	0
Hypotension	0	1 (16.7)	1 (16.7)	2 (33.3)	0	0	0	0
Fatigue	0	0	0	2 (33.3)	0	0	0	0
Feeling hot	0	0	0	2 (33.3)	0	0	0	0
Hyperhidrosis	0	0	0	2 (33.3)	0	0	0	0

QD once daily, TEAE treatment-emergent adverse event, TPIP treprostinil palmitil inhalation powder