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NCT05967299 · ClinicalTrials.gov registry record · Phase 1
Study of Intravenous ZMA001 in Healthy Subjects
A Phase 1 study of Pulmonary Arterial Hypertension PAH, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 96
- Enrollment target
- 1
- Study location
NCT05967299 is a Phase 1 study of Pulmonary Arterial Hypertension PAH that is actively recruiting participants, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 96 participants, above the 29-participant average among 5 other Pulmonary Arterial Hypertension PAH trials with a reported enrollment target (231% higher). The trial reports 1 study location across 1 state.
The verdict
NCT05967299, a Phase 1 study of Pulmonary Arterial Hypertension PAH, is actively recruiting participants, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 96 participants
- Enrollment target
- 1
- Study location
Study Summary
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 Studied
Interventions
- OTHER Placebo Cohort 1 (1.5 mg/kg/dose) only
- DRUG ZMA001 (BC-NKA-20008)
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 96 participants |
| Start Date | 2023-11-27 |
| Est. Completion | 2027-11-30 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05967299
The ClinicalTrials.gov registry entry for NCT05967299 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 96 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 29-participant average among 5 other Pulmonary Arterial Hypertension PAH trials with a reported enrollment target (231% higher). The listed sponsor is National Heart, Lung, and Blood Institute (NHLBI), which has 501 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Pulmonary Arterial Hypertension PAH appearing as the primary indexed condition, and to 2 interventions - of which Placebo Cohort 1 (1.5 mg/kg/dose) only is the first listed.
NCT05967299 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT05967299 about?
NCT05967299 is a clinical study titled "Study of Intravenous ZMA001 in Healthy Subjects". 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 fac...
What is the current status of trial NCT05967299?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 96 participants. The study started on 2023-11-27. Estimated completion is 2027-11-30.
What conditions does trial NCT05967299 study?
This clinical trial studies the following conditions: Pulmonary Arterial Hypertension PAH.
What interventions are being tested in trial NCT05967299?
The interventions under investigation include: Placebo Cohort 1 (1.5 mg/kg/dose) only (OTHER), ZMA001 (BC-NKA-20008) (DRUG).
Who is sponsoring clinical trial NCT05967299?
This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 501 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05967299 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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