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 range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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)
. 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.
. A history of human immunodeficiency virus (HIV) infection.
. History of severe drug or excipient allergy or hypersensitivity
. Known allergy to any of the components of the investigational drug or placebo
. Recent infection or febrile illness within the past 14 days
. Treatment with another investigational drug within the past 30 days or 5 half-lives, whichever is longer
. Any vaccination within the past 4 weeks or receipt of a live-attenuated vaccine within the past 6 months
. Use of tobacco products within the past 3 months