A Randomized, Double-Blind, Parallel Group, Phase 2 Study to Assess the Safety, Tolerability, and Efficacy of Once Weekly Subcutaneous Injections of a Sustained-Release VIP Analogue, PB1046, in Adult Subjects with Symptomatic Pulmonary Arterial Hypertension

PhaseBio Pharmaceuticals, Inc.0 sites63 target enrollmentJanuary 9, 2020

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: PhaseBio Pharmaceuticals, Inc.
Enrollment: 63
Status: Active, not recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

January 9, 2020

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

PhaseBio Pharmaceuticals, Inc.

Eligibility Criteria

Inclusion Criteria

•Subjects will be eligible for inclusion in the study if they meet all the following criteria at screening and up to the time of first dose as indicated:
•1\. Male and female subjects with PAH, \=18 and \= 79 years of age, who are symptomatic and have reduced exercise capacity due primarily to their PAH diagnosis and have been assessed by a qualified individual (i.e. physician, physician assistant, nurse practitioner) to be in NYHA/WHO functional class II or III
•2\. Willing and able to sign a written informed consent prior to all study\-related procedures
•3\. Subjects with PAH belonging to one of the following subgroups of the NICE Clinical Classification of Pulmonary Hypertension Group 1:
•a. Idiopathic
•b. Heritable
•c. Drug or toxin\-induced
•d. Associated with connective tissue disease, HIV infection, portal hypertension, congenital heart disease (pulmonary\-to\-systemic shunt, e.g., atrial septal defect (ASD) or patent ductus arteriosus (PDA), at least 1 year after surgical repair)
•4\. Two 6MWT results \> 50 m and \< 550 m prior to randomization with results \+/\- 10% of each other. Note: Up to four tests may be conducted between Screening and Randomization for eligibility purposes (no more than two 6MWT may be performed on the same day, and must be completed at least two hours apart)
•5\. Hemodynamic assessment of PAH by right heart catheterization (RHC) demonstrating elevated mPAP and PVR as indicated below during the Screening Period

Exclusion Criteria

•Subjects will be excluded from the study if they meet any of the following criteria:
•1\. Concomitant medical disorder, condition, or history, that in the opinion of the Investigator would impair the subject’s ability to participate in or complete the requirements of the study
•2\. Concomitant medical disorder that is expected to limit the subject’s life\-expectancy to \= 1 year
•3\. Pregnant or lactating female subjects
•4\. First positive result from serology testing at Visit 1 (screening labs) for HIV, HBsAg, or HCV prior to randomization
•5\. Participation in another investigational drug study within 30 days prior to screening or participating in a non\-medication study which, in the opinion of the Investigator, would interfere with the study compliance or outcome assessments
•6\. Use of subcutaneous prostanoid/prostacyclin therapy for PAH within 30 days prior to the screening visit
•7\. More than mild mitral or aortic valve disease, left ventricular ejection fraction \< 50%, or left ventricular regional wall motion abnormality suggestive of active coronary artery disease on documented 2D\-echocardiography occurring within 12 months of Screening
•8\. Sustained SBP \< 95 mmHg and/or diastolic blood pressure (DBP) \< 50 mmHg (confirmed by a duplicate seated reading) on at least 3 consecutive readings (self\-monitored or office) at screening and prior to dosing, or overt symptomatic hypotension
•9\. Sustained resting heart rate \>110 beats per minute (BPM) (confirmed by duplicate assessments of office vital signs or consecutive ECG assessments) on at least 3 consecutive readings at screening and prior to dosing