Study of Intravenous ZMA001 in Healthy Subjects

Recruiting now · Phase 1 · Has a placebo group

Conditions studied: Pulmonary Arterial Hypertension PAH

In brief

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.

Key facts

Study ID

NCT05967299

Run by

National Heart, Lung, and Blood Institute (NHLBI)

People needed

96

Starts

2023-11-27

Expected to finish

2027-11-30

Last updated by the study team

2026-06-05

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• An individual who meets any of the following criteria prior to informed consent will be excluded from participation in this study:
• 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
• Illicit drug use (e.g. cocaine, opioids, methamphetamine, PCP) within the past 6 months or positive urine drug screen at Screening Visit
• Marijuana (cannabis) use within the past 30 days or positive urine drug screen at Screening Visit
• History of alcohol abuse within the past 2 years
• Current clinically significant medical illness that is uncontrolled despite appropriate medical treatment including (but not limited to) hematologic, oncologic, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, infectious, hepatic, dermatologic, psychiatric, neurologic, autoimmune or allergic disease
• Body mass index less than 17 or greater than 32 kg/m\^2
• Clinically significant abnormal results on clinical blood testing completed at the Screening Visit
• Electrocardiographic evidence of clinically relevant heart disease
• Diabetes mellitus requiring medical treatment
• Received another monoclonal antibody in the past 30 days
• Use of herbal supplements, or similar products within the past 2 weeks
• Blood donation equal to or above 500 mL within 2 months prior to dosing.
• Any other finding that, in the judgment of the Investigator, would increase the risk of having an adverse outcome from participating in the study.
• Justification to exclude minors: Given that the vast majority of patients with PAH are >18 years of age and the fact that this is a first in human study, the risks of including children/minors (ie. subjects < 18 yrs of age) are not justified given the limited potential benefits of including these subjects.
• Justification to exclude adults >60 years old: Subjects > 60 years of age are more likely to have comorbid medical conditions that could place them at increased risk of participation.

Where it is running

• National Institutes of Health Clinical Center — Bethesda, Maryland, United States (enrolling)

Full record on ClinicalTrials.gov

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