Intravenous ZMA001 for Pulmonary Arterial Hypertension
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, you cannot participate if you have used tobacco, recreational drugs, or herbal supplements recently, or if you have a significant uncontrolled medical condition.
What evidence supports the effectiveness of the drug ZMA001 for treating pulmonary arterial hypertension?
The research highlights that various drugs targeting the prostacyclin, endothelin, and nitric oxide pathways have improved symptoms and survival in pulmonary arterial hypertension. While ZMA001 is not specifically mentioned, similar treatments have shown benefits, suggesting potential effectiveness.12345
How does the drug ZMA001 differ from other treatments for pulmonary arterial hypertension?
ZMA001 is administered intravenously, which is a common route for treating pulmonary arterial hypertension, but it may offer a novel formulation or mechanism compared to existing intravenous prostacyclin treatments. Unlike traditional prostacyclin therapies that require external pumps and carry risks of infections and malfunctions, ZMA001 might provide a new approach to mitigate these issues.678910
What is the purpose of this trial?
Background:A number of diseases can cause a type of lung injury called pulmonary arterial hypertension (PAH). Most people who develop PAH do not survive more than a few years. A new study drug (ZMA001) may help. ZMA001 is a monoclonal antibody. This type of drug consists of proteins, made in a facility, that are very similar to proteins in a human body. But before giving ZMA001 to people sick with PAH, researchers want to find out how the drug affects healthy people.Objective:To test a drug (ZMA001) in healthy volunteers.Eligibility:Healthy adults aged 18 to 60 years.Design:Participants will be screened. They will have a physical exam with blood tests. They will have a urine test for drug use. They will have a test of their heart function.Participants will come to the clinic for 1 inpatient visit of up to 48 hours.ZMA001 is a liquid administered through a tube attached to a needle inserted into a vein in the arm. Participants will receive this drug only once, during their inpatient stay. Some participants will receive the drug; others will receive a placebo. A placebo is a treatment that looks just like the real drug but contains no medicine. Participants will not know which treatment they are getting.After a screening visit, participants will have 1 inpatient visit and up to 6 outpatient visits over 16 weeks after receiving the treatment. Blood draws and other tests will be repeated. Each outpatient visit is approximately 2 hours long.This study is the first time ZMA001 will be administered to people.
Research Team
Jason M Elinoff, M.D.
Principal Investigator
National Heart, Lung, and Blood Institute (NHLBI)
Eligibility Criteria
Healthy adults aged 18-60 can join this study testing ZMA001, a new drug for lung injury from PAH. Participants must be in good health, not use tobacco or certain drugs recently, and agree to lifestyle rules and contraception methods. More women are needed as the trial aims for gender balance.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single intravenous dose of ZMA001 or placebo during a 48-hour inpatient stay
Follow-up
Participants are monitored for safety and pharmacokinetics with up to 6 outpatient visits over 16 weeks
Treatment Details
Interventions
- ZMA001
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Heart, Lung, and Blood Institute (NHLBI)
Lead Sponsor
Zymedi, Co., Ltd.
Collaborator