Study of Intravenous ZMA001 in Healthy Subjects (NCT05967299) | Clinical Trial Compass
RecruitingPhase 1
Study of Intravenous ZMA001 in Healthy Subjects
United States96 participantsStarted 2023-11-27
Plain-language summary
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 in Cohort 1 only. 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 in Cohort 1. Cohorts 2-4 will receive a single dose of the study drug, administered through a tube attached to a needle inserted into a vein in the arm.
After a screening visit, participants will have 1 inpatient visit and up to 8 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.
Who can participate
Age range18 Years – 60 Years
SexALL
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Inclusion criteria
✓. Stated willingness to comply with all study procedures and availability for the duration of the study
✓. Male\* or female, aged 18 to 60 years, inclusive
✓. In good general health as evidenced by medical history
✓. Females of childbearing potential agree to use an accepted method of contraception (see below) throughout study participation and for 120 days after study drug infusion.
✓. Males sexually active with a female partner must agree to use a condom with spermicide for 120 days after study drug infusion or be surgically sterile for at least 90 days before screening. Males must also agree to not donate sperm for 120 days after study drug administration.
✓. Agreement to adhere to Lifestyle Considerations throughout study duration
✓. Ability of subject to understand and the willingness to sign a written informed consent document.
Exclusion criteria
✕. Pregnancy or lactation. Females of childbearing potential must have a negative serum Beta-human chorionic gonadotropin test no more than 48 hours from study drug infusion.
What they're measuring
1
Safety and tolerability of ZMA001 in healthy subjects
Timeframe: day 113
Trial details
NCT IDNCT05967299
SponsorNational Heart, Lung, and Blood Institute (NHLBI)