NCT03315507

A Study to Assess the Safety, Tolerability, and Hemodynamic Response of PB1046 in Subjects With PAH

An Open-Label, Dose Titration Study to Assess the Safety, Tolerability, and Hemodynamic Response of PB1046, A Sustained-Release Analogue of Vasoactive Intestinal Peptide, In Adult Subjects With Pulmonary Arterial Hypertension

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: PhaseBio Pharmaceuticals Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

PB1046-PT-CL-0005 is an open-label, dose-titration study to assess the safety, tolerability, and hemodynamic effects of individually dose-titrated PB1046 administered by weekly subcutaneous injection for 8 weeks in adult subjects with PAH who have a permanently implanted hemodynamic monitor in the distal pulmonary artery. The primary objectives of the study are to assess the overall safety, tolerability, and hemodynamic profile of a PB1046 across an individually titrated dose range.

Conditions

• Pulmonary Arterial Hypertension

Interventions

Type	Name	Description
DRUG	PB1046 Subcutaneous Injection	Eight weekly doses of PB1046.

Timeline

• Start date: 2017-10-20
• Primary completion: 2019-08-08
• Completion: 2019-08-08
• First posted: 2017-10-20
• Last updated: 2019-10-08

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study