A Phase 1, Placebo Controlled, Blinded, Multiple Dose Escalation Study of AIR001 (Sodium Nitrite Inhalation Solution) in Healthy Subjects, an Assessment of the Tolerability in Combination With Oral Sildenafil, and an Open-Label Study of Multiple Dose AIR001 in Patients With Pulmonary Arterial Hypertension
Abstract
This is a four-part study of the safety, tolerability, and PK profile of sodium nitrite inhalation solution (AIR001) of ascending multiple doses (Part A) and of escalating doses with steady-state sildenafil (Part B) to healthy male and female subjects, as well as assessment of the safety and tolerability of multiple doses of AIR001 to patients with pulmonary arterial hypertension (part C) with a single dose PK study of AIR001 utilizing three different nebulizers (Part D).
Conditions: Pulmonary Hypertension, Pulmonary Arterial Hypertension.
Primary outcome: Safety and tolerability of ascending multiple dose AIR001 (Part A); Safety and tolerability of single escalating doses of AIR001 with sildenafil (Part B); Composite PK for Plasma Nitrite and Nitrate(Part A); Composite PK for Plasma Nitrite and Nitrate in the presence of steady state Sildenafil(Part B); Safety and tolerability of multiple doses of AIR001 administered to patients with PAH (PART C); Safety and tolerability of single doses of AIR001 administered to healthy subjects with each of three different nebulizers (PART D); Composite PK for Plasma Nitrite and Nitrate(Part C); Composite PK for Plasma Nitrite and Nitrate(Part D).
Enrollment: 42 participants.
How strong is the evidence?
Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 42 participants or records.
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