Clinical Trial Finder

Key

Inclusion Criteria:

• - Able to understand and complete study requirements and provide written informed consent.

• - Males and females ≥18 and ≤75 years of age at the time of informed consent.

All sexually active male subjects and female subjects of childbearing potential must use an acceptable, highly effective method of contraception.

• - Diagnosed with PAH belonging to Group 1 pulmonary hypertension (PH) per European Society of Cardiology/European Respiratory Society Guidelines for the diagnosis and treatment of PH.

• - Documentation of having PAH as confirmed by right heart catheterization (RHC) within 12 months prior to screening and meeting the following criteria: - New York Heart Association functional class II, III, or IV at the screening visit.

• - Documented stable doses.

• - Can complete a screening 6MWD of ≥150 meters.

• - Forced expiratory volume in 1 second (FEV1) >65% of predicted and FEV1/forced vital capacity (FVC) ratio >65% at screening.

Key

Exclusion Criteria:

• - Pregnant or lactating female at screening or baseline.

• - Left ventricular ejection fraction of ≤45% on a historical echocardiogram within 6 months of screening.

Patients who recovered their LVEF culd be allowed, as judged by investigator.

• - History of sleep apnea, parenchymal lung disease, or left-sided heart disease (including but not limited to aortic or mitral valve disease, pericardial constriction, restrictive or congestive cardiomyopathy, or coronary artery disease) per investigator's discretion.

• - Experienced an acute exacerbation of disease or hospitalization for any reason within 30 days of signing the ICF or prior to baseline.

• - Use of any investigational drug/device or participation in any other investigational study with therapeutic intent within 30 days or 5 half-lives, whichever is longer, prior to signing the ICF.

• - Systolic blood pressure <90 mmHg or ≥160 mmHg at baseline.

• - Screening electrocardiogram (ECG) with QTcF >450 ms for male subjects or >480 ms for female subjects.

• - Musculoskeletal disorder (eg, arthritis affecting the lower limbs, recent hip or knee joint replacement) or any disease that would likely be the primary limit to ambulation or subject is connected to a machine that is not portable enough to allow for a 6-minute walk test (6MWT).

• - Alanine aminotransferase or aspartate aminotransferase levels >3 × upper limit of normal reference range, clinically significant liver disease/dysfunction, or known Child-Pugh Class C hepatic disease.

• - Estimated glomerular filtration rate <30 mL/min/1.73 m2 or requires dialysis.

This single-arm, Phase 3, 2-part, open-label, multicenter study aims to demonstrate the safety and tolerability of repeated doses of L606 in patients with PAH switching from a stable Tyvaso dose. The current Phase 3 study will help determine the short-term and long-term safety and tolerability of L606 in this patient population. The study will also evaluate the steady-state pharmacokinetics (PK) of L606 as compared to Tyvaso, effects on exercise ability (6-minute walk distance [6MWD] and Borg Dyspnea Score), quality of life (QoL), and treatment satisfaction with L606 in patients with PAH. Part 1 of the study is short-term (2-week) evaluation of L606 in patients with PAH. Part 2 of the study will continue to assess the long-term safety and efficacy of L606 in patients with PAH. Results of Part 1 and Part 2 of the study will be presented in separate clinical study reports and clinical study report of Part 1 of the study will be submitted as part of new drug application.

Arms

Experimental: L606

Interventions

Combination Product: - L606 inhalation suspension

L606 inhalation suspension, twice daily dosing