Is NCT05967299 recruiting in Bethesda, MD?

Yes, NCT05967299 is currently recruiting participants at its Bethesda, MD location. This pulmonary arterial hypertension pah clinical trial is actively enrolling qualified participants.

Is participation in this Bethesda clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Pulmonary Arterial Hypertension PAH Clinical Trial in Bethesda, MD

Q: How do I join the pulmonary arterial hypertension pah clinical trial in Bethesda?

To join this clinical trial in Bethesda, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

About This Pulmonary Arterial Hypertension PAH Study in Bethesda

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.

Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

Who Can Participate

Inclusion Criteria

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

Stated willingness to comply with all study procedures and availability for the duration of the study

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.

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:

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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Bethesda?

Yes, this clinical trial (NCT05967299) has an active research site in Bethesda, MD that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Pulmonary Arterial Hypertension PAH Treatment Options in Bethesda, MD

If you're searching for pulmonary arterial hypertension pah treatment options in Bethesda, MD, this clinical trial (NCT05967299) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Bethesda research site is actively enrolling participants for this clinical trial. You'll receive care from experienced pulmonary arterial hypertension pah specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all pulmonary arterial hypertension pah clinical trials near you to find additional studies recruiting in your area.

Pulmonary Arterial Hypertension PAH Clinical Trial in Bethesda, MD

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