This study is currently not recruiting participants.

A phase 1 clinical trial of ABI-009 an mTOR inhibitor for patients with severe pulmonary arterial hypertension (PAH)

Investigating the Safety and Effects of an Investigational Medication for Severe Pulmonary Artery Hypertension

Not Recruiting
18 years - 100 years
All
Phase N/A

Brief description of study.

The purpose of this study is to look at the safety and effects of ABI-009, an investigational drug that has not yet been approved by the Food and Drug Administration on patients with severe pulmonary artery hypertension.

Detailed description of study

The significance of this study is that it offers a new approach to the treatment of debilitating PAH by targeting the disease biology, i.e. proliferation of cells. This is a phase 1 prospective, open label, single arm dose finding study to determine the maximum tolerated dose (MTD), dose limiting toxicity (DLT), safety and preliminary efficacy of ABI-009 given intravenously to subjects with severe WHO Group 1 pulmonary arterial hypertension who are WHO Functional Class 3 in spite of treatment with 2 or more background PAH therapies.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: severe pulmonary arterial hypertension
  • Age: 18 years - 100 years
  • Gender: All

This study investigates the safety and effects of an investigational medication in patients with severe pulmonary artery hypertension (PAH). PAH is a condition where the blood pressure in the lungs' arteries is higher than normal, which can make it hard for the heart to pump blood through the lungs. The study aims to find out how the investigational medication affects this condition and if it can be safely used in patients.

Participants in this study will receive the investigational medication intravenously. The study will determine the maximum dose that can be safely given to the patients, as well as any side effects that might occur. The medication aims to target and reduce the growth of cells that contribute to PAH, which is a new approach to managing this condition.

  • Who can participate: Participants must have severe pulmonary artery hypertension and be classified as WHO Functional Class 3. They should be on two or more PAH therapies.
  • Study details: Participants will receive the investigational medication intravenously to evaluate safety and effects. The study will identify the highest dose that can be safely administered and monitor for side effects.
Updated on 23 Sep 2024. Study ID: 1802341349

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