Study of Intravenous ZMA001 in Healthy Subjects

A Phase 1 Single-Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Intravenous ZMA001 in Healthy Subjects

Study of Intravenous ZMA001 in Healthy Subjects (NCT05967299) is a Phase 1 interventional studying Pulmonary Arterial Hypertension PAH, sponsored by National Heart, Lung, and Blood Institute (NHLBI). RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Pulmonary Arterial Hypertension PAH, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 96 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Pulmonary Arterial Hypertension PAH subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

* Who May Qualify: In order to be eligible to participate in this study, an individual must meet all of the following criteria: 1. Stated willingness to comply with all study procedures and availability for the duration of the study 2. Male\* or female, aged 18 to 60 years, inclusive 3. In good general health as evidenced by medical history 4. 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. 5. 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. 6. Agreement to adhere to Lifestyle Considerations throughout study duration 7. Ability of subject to understand and the willingness to sign a written willing to sign a consent form document. - Enrollment of healthy male subjects will be limited to no more than 14 out of the total study cohort of 32 in order to ensure an adequate representation of female subjects. Accepted methods of contraception for females of childbearing potential: - Use of an implanted or intrauterine hormonal device for at least 30 consecutive days before study drug infusion - Use of oral, patch or injectable contraceptives or a vaginal hormonal device for at least 30 consecutive days before study drug infusion - Use of a non-hormonal intrauterine device for at least 30 consecutive days before study drug infusion - Two barrier methods such as a diaphragm with spermicide or a condom with spermicide Who Should NOT Join This Trial: An individual who meets any of the following criteria prior to willing to sign a consent form will be excluded from participation in this study: ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

* INCLUSION CRITERIA: In order to be eligible to participate in this study, an individual must meet all of the following criteria: 1. Stated willingness to comply with all study procedures and availability for the duration of the study 2. Male\* or female, aged 18 to 60 years, inclusive 3. In good general health as evidenced by medical history 4. 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. 5. 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. 6. Agreement to adhere to Lifestyle Considerations throughout study duration 7. Ability of subject to understand and the willingness to sign a written informed consent document. * Enrollment of healthy male subjects will be limited to no more than 14 out of the total study cohort of 32 in order to ensure an adequate representation of female subjects. Accepted methods of contraception for females of childbearing potential: * Use of an implanted or intrauterine hormonal device for at least 30 consecutive days before study drug infusion * Use of oral, patch or injectable contraceptives or a vaginal hormonal device for at least 30 consecutive days before study drug infusion * Use of a non-hormonal intrauterine device for at least 30 consecutive days before study drug infusion * Two barrier methods such as a diaphragm with spermicide or a condom with spermicide EXCLUSION CRITERIA: An individual who meets any of the following criteria prior to informed consent will be excluded from participation in this study: 1. 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. 2. A history of human immunodeficiency virus (HIV) infection. 3. History of severe drug or excipient allergy or hypersensitivity 4. Known allergy to any of the components of the investigational drug or placebo 5. Recent infection or febrile illness within the past 14 days 6. Treatment with another investigational drug within the past 30 days or 5 half-lives, whichever is longer 7. Any vaccination within the past 4 weeks or receipt of a live-attenuated vaccine within the past 6 months 8. Use of tobacco products within the past 3 months 9. Illicit drug use (e.g. cocaine, opioids, methamphetamine, PCP) within the past 6 months or positive urine drug screen at Screening Visit 10. Marijuana (cannabis) use within the past 30 days or positive urine drug screen at Screening Visit 11. History of alcohol abuse within the past 2 years 12. 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 13. Body mass index less than 17 or greater than 32 kg/m\^2 14. Clinically significant abnormal results on clinical blood testing completed at the Screening Visit 15. Electrocardiographic evidence of clinically relevant heart disease 16. Diabetes mellitus requiring medical treatment 17. Received another monoclonal antibody in the past 30 days 18. Use of herbal supplements, or similar products within the past 2 weeks 19. Blood donation equal to or above 500 mL within 2 months prior to dosing. 20. 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.

Treatments Being Tested

OTHER

Placebo Cohort 1 (1.5 mg/kg/dose) only

30mg/ml Sucrose

DRUG

ZMA001 (BC-NKA-20008)

ZMA001 is a fully human, monoclonal antibody (IgG1) that inhibits migration of activated monocytes and macrophages and reduces pulmonary vascular remodeling and pulmonary artery pressure in pre-clinical rodent models of pulmonary arterial hypertension (PAH).

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05967299), the sponsor (National Heart, Lung, and Blood Institute (NHLBI)), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT05967299 clinical trial studying?

Who can participate in NCT05967299?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT05967299?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT05967299. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05967299. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.