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Study of ZMA001 in Healthy Subjects for Pulmonary Arterial Hypertension

This study is testing a new drug called ZMA001 in healthy volunteers. ZMA001 is a monoclonal antibody, a type of protein designed to stop certain cells from moving and to reduce problems in the lungs that cause pulmonary arterial hypertension (PAH). Before ZMA001 can be given to people with PAH, researchers need to understand how it affects healthy individuals. The main goal is to check the safety and how well healthy people tolerate ZMA001. You may be able to join if you are a healthy adult between 18 and 60 years old. This study aims to enroll 96 participants.

Study design
This is an interventional study, meaning participants will receive either ZMA001 or a placebo (a substance with no active drug). The study plans to enroll 96 healthy volunteers.
What's involved
You will be screened, which includes a physical exam, blood tests, a urine drug test, and a heart function test. The study will monitor your safety and tolerability of ZMA001 through day 113.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for safety and tolerability of ZMA001 through day 113 after receiving the intervention.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05967299

Study of Intravenous ZMA001 in Healthy Subjects

Recruiting
PHASE1Ages 18–60InterventionalBasic science
National Heart, Lung, and Blood Institute (NHLBI)
~96 participants
Updated 2026-06-05 on ClinicalTrials.gov
What's tested:Placebo Cohort 1 (1.5 mg/kg/dose) onlyZMA001 (BC-NKA-20008)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and tolerability of ZMA001 in healthy subjects
Measured over day 113

Conditions

Pulmonary Arterial Hypertension PAH

Explore related trials

Healthy Volunteer

Where it's being run

1 sites across 1 states
Maryland1

Study leadership

  • Jason M Elinoff, M.D. · PRINCIPAL_INVESTIGATOR · National Heart, Lung, and Blood Institute (NHLBI)

Who to contact

Sandra Cooper Bennett, R.N.
[email protected]
(240) 328-0465
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.
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

What this trial measures

  • Safety and tolerability of ZMA001 in healthy subjectsday 113

    The number of all-cause, treatment-emergent adverse events, grade 1 and above (following CTCAE v5.0 criteria) through day 113