drugset / Trial / NCT02587325

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

NCT02587325

Phase 1 Completed 15 enrolled Aadi Bioscience, Inc.
Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start
2017-04-01
Primary completion
2022-08-16
Completion
2022-09-16

Drugs

EvaluationDrugModalityDoseRoute
Subject nab-sirolimus Unknown 1 mg/m2 Intravenous
Subject nab-sirolimus Unknown 2.5 mg/m2 Intravenous
Subject nab-sirolimus Unknown 5 mg/m2 Intravenous
Subject nab-sirolimus Unknown 7.5 mg/m2 Intravenous
Subject nab-sirolimus Unknown 10 mg/m2 Intravenous