drugset / Trial / NCT02587325
Phase 1/1b Study With Nab-sirolimus for Patients With Severe Pulmonary Arterial Hypertension
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |