NCT02587325

Phase 1/1b Study With Nab-sirolimus for Patients With Severe Pulmonary Arterial Hypertension

A Phase 1/1b Clinical Trial of ABI-009, an mTOR Inhibitor, for Patients With Severe Pulmonary Arterial Hypertension (PAH)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Aadi Bioscience, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

mTOR activation has been shown to be relevant in the development and progression of pulmonary hypertension. Inhibition of mTOR has been shown to reverse or regress pulmonary hypertension in animal models. nab-Sirolimus (also known as ABI-009, nab-rapamycin) is an albumin-bound mTOR inhibitor with improved penetration in lung tissue.

Detailed description

nab-Sirolimus, an mTOR inhibitor, is a novel formulation of albumin-bound sirolimus nanoparticles and has produced encouraging results in oncology at doses up to 100 mg/m2 given once weekly IV. This study is aimed to determine the optimal clinial dose of once weekly IV nab-sirolimus in patients with PAH and safety of 16 weeks of therapy (Phase 1, Dose finding Safety Part) followed optionally by up to 32 weeks of therapy (Extension Part).

Conditions

• Pulmonary Hypertension

Interventions

Type	Name	Description
DRUG	nab-sirolimus	nab-sirolimus is an mTOR inhibitor

Timeline

• Start date: 2017-04-01
• Primary completion: 2022-08-16
• Completion: 2022-09-16
• First posted: 2015-10-27
• Last updated: 2024-11-25
• Results posted: 2024-11-25

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study