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.