Actively Recruiting
Study of Intravenous ZMA001 in Healthy Subjects
Led by National Heart, Lung, and Blood Institute (NHLBI) · Updated on 2026-04-28
96
Participants Needed
1
Research Sites
209 weeks
Total Duration
On this page
Sponsors
N
National Heart, Lung, and Blood Institute (NHLBI)
Lead Sponsor
Z
Zymedi, Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of Intravenous ZMA001 in Healthy Subjects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willingness to comply with all study procedures and be available for the entire study duration
- Male or female aged 18 to 60 years inclusive
- In good general health based on medical history
- Females of childbearing potential must agree to use accepted contraception during the study and for 120 days after infusion
- Sexually active males must use condoms with spermicide for 120 days after infusion or be surgically sterile for at least 90 days before screening
- Males must agree not to donate sperm for 120 days after drug administration
- Agreement to follow lifestyle considerations throughout the study
- Ability and willingness to sign informed consent
You will not qualify if you...
- Pregnancy or lactation; females must have a negative pregnancy test within 48 hours before drug infusion
- History of HIV infection
- Severe allergy or hypersensitivity to drugs or excipients
- Known allergy to any component of the study drug or placebo
- Recent infection or fever within past 14 days
- Use of another investigational drug within past 30 days or 5 half-lives
- Vaccination within past 4 weeks or live vaccine within past 6 months
- Use of tobacco products within past 3 months
- Use of illicit drugs or positive drug screen within past 6 months
- Cannabis use or positive drug screen within past 30 days
- History of alcohol abuse within past 2 years
- Uncontrolled significant medical illness including hematologic, oncologic, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, infectious, hepatic, dermatologic, psychiatric, neurologic, autoimmune or allergic diseases
- Body mass index less than 17 or greater than 32 kg/m^2
- Abnormal blood test results at screening
- ECG evidence of significant heart disease
- Diabetes requiring treatment
- Receipt of another monoclonal antibody within past 30 days
- Use of herbal supplements within past 2 weeks
- Blood donation of 500 mL or more within 2 months before dosing
- Any other condition that increases risk as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
S
Sandra Cooper Bennett, R.N.
CONTACT
J
Jason M Elinoff, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here