A Phase 3 Study to Evaluate the Safety and Tolerability of L606 in Subjects With PAH
This single-arm, Phase 3, 2-part, open-label, multicenter study aims to demonstrate the safety and tolerability of L606 in patients with PAH switching from a stable Tyvaso dose. The study will determine the short-term and long-term safety and tolerability of L606 in this patient population; also evaluate the steady-state pharmacokinetics (PK) of L606 as compared to Tyvaso, effects on exercise ability, quality of life, and treatment satisfaction with L606 in patients with PAH.
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years - 75 Years|
- - 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.
- - 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.
- - Pregnant or lactating female at screening or baseline.
- - Left ventricular ejection fraction of ≤45% on a historical echocardiogram within 6 months of screening.
- - 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 trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Pharmosa Biopharm Inc.|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Jeremy P Feldman, MDElizabeth Gay, MDMichael G Risbano, MD|
|Principal Investigator Affiliation||Arizona Pulmonary SpecialistsBrigham and Women's HospitalUPMC Montefiore|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|Pulmonary Arterial Hypertension|
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.
Combination Product: - L606 inhalation suspension
L606 inhalation suspension, twice daily dosing
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Arizona Pulmonary Specialists
Phoenix, Arizona, 85012