20 Participants Needed

Intravenous ZMA001 for Pulmonary Arterial Hypertension

SC
JM
Overseen ByJason M Elinoff, M.D.
Age: 18 - 65
Sex: Any
Trial Phase: Phase 1
Sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you cannot participate if you have used tobacco, recreational drugs, or herbal supplements recently, or if you have a significant uncontrolled medical condition.

What evidence supports the effectiveness of the drug ZMA001 for treating pulmonary arterial hypertension?

The research highlights that various drugs targeting the prostacyclin, endothelin, and nitric oxide pathways have improved symptoms and survival in pulmonary arterial hypertension. While ZMA001 is not specifically mentioned, similar treatments have shown benefits, suggesting potential effectiveness.12345

How does the drug ZMA001 differ from other treatments for pulmonary arterial hypertension?

ZMA001 is administered intravenously, which is a common route for treating pulmonary arterial hypertension, but it may offer a novel formulation or mechanism compared to existing intravenous prostacyclin treatments. Unlike traditional prostacyclin therapies that require external pumps and carry risks of infections and malfunctions, ZMA001 might provide a new approach to mitigate these issues.678910

What is the purpose of 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. 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.After a screening visit, participants will have 1 inpatient visit and up to 6 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.

Research Team

JM

Jason M Elinoff, M.D.

Principal Investigator

National Heart, Lung, and Blood Institute (NHLBI)

Eligibility Criteria

Healthy adults aged 18-60 can join this study testing ZMA001, a new drug for lung injury from PAH. Participants must be in good health, not use tobacco or certain drugs recently, and agree to lifestyle rules and contraception methods. More women are needed as the trial aims for gender balance.

Inclusion Criteria

Agreement to adhere to Lifestyle Considerations throughout study duration
Stated willingness to comply with all study procedures and availability for the duration of the study
I am a man who will use a condom or am surgically sterile, and won't donate sperm for 120 days after treatment.
See 5 more

Exclusion Criteria

I have not had a fever or infection in the last 2 weeks.
My BMI is either below 17 or above 32.
I have a significant ongoing medical condition.
See 13 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks
1 visit (in-person)

Treatment

Participants receive a single intravenous dose of ZMA001 or placebo during a 48-hour inpatient stay

48 hours
1 inpatient visit

Follow-up

Participants are monitored for safety and pharmacokinetics with up to 6 outpatient visits over 16 weeks

16 weeks
6 visits (in-person)

Treatment Details

Interventions

  • ZMA001
Trial Overview The trial is giving healthy volunteers either ZMA001 or a placebo through an IV to see how it affects them. It's the first time people will get ZMA001. They'll stay at the clinic up to 48 hours then have follow-up visits over 16 weeks with blood tests and heart checks.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: ZMA001 (BC-NKA-20008)Experimental Treatment1 Intervention
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).
Group II: PlaceboPlacebo Group1 Intervention
Placebo for ZMA001 is supplied in a single-use 10 mL glass vial. Each vial contains 30 mg/mL of sucrose.Placebo drug is manufactured using the same ingredients as active drug (20 mM histidine-HCl buffer \[pH 5.6\], 30 mg/mL sucrose, 0.070 w/v% polysorbate 80) excluding ZMA001 antibody and is packed in the same vial.

Find a Clinic Near You

Who Is Running the Clinical Trial?

National Heart, Lung, and Blood Institute (NHLBI)

Lead Sponsor

Trials
3,987
Recruited
47,860,000+

Zymedi, Co., Ltd.

Collaborator

Trials
1
Recruited
100+

Findings from Research

Since the mid-1990s, nine medications targeting the prostacyclin, endothelin, and nitric oxide pathways have been developed for treating pulmonary arterial hypertension (PAH), leading to significant improvements in patients' functional capacity, symptoms, and survival rates.
While current treatments for WHO Group 1 PAH are effective, they are not curative, and ongoing research aims to develop new therapies that may halt or reverse disease progression.
WHO Group 1 pulmonary arterial hypertension: current and investigative therapies.Ventetuolo, CE., Klinger, JR.[2014]
Recent advancements in therapies have significantly enhanced the treatment options available for pulmonary arterial hypertension (PAH), leading to better management of the condition.
These new therapies aim to improve patient outcomes by targeting the underlying mechanisms of PAH, although specific details on the types of therapies and their efficacy were not provided in the abstract.
Understanding pulmonary arterial hypertension.Holcomb, SS.[2019]
A comprehensive review of clinical trials has led to an evidence-based treatment algorithm for pulmonary arterial hypertension (PAH), emphasizing the importance of tailored therapies based on patient classification, particularly for idiopathic and heritable PAH.
For patients in World Health Organization (WHO) functional class III, oral phosphodiesterase-5 inhibitors or endothelin-receptor antagonists are recommended if they do not respond to acute vasoreactivity testing, while continuous intravenous epoprostenol is the preferred treatment for those in class IV.
Updated evidence-based treatment algorithm in pulmonary arterial hypertension.Barst, RJ., Gibbs, JSR., Ghofrani, HA., et al.[2021]

References

WHO Group 1 pulmonary arterial hypertension: current and investigative therapies. [2014]
Understanding pulmonary arterial hypertension. [2019]
Updated evidence-based treatment algorithm in pulmonary arterial hypertension. [2021]
Current treatment approaches to pulmonary arterial hypertension. [2022]
Comparative analysis of clinical trials and evidence-based treatment algorithm in pulmonary arterial hypertension. [2021]
Subcutaneous implantation of a new intravenous pump system for prostacyclin treatment in patients with pulmonary arterial hypertension. [2014]
Selexipag for the treatment of pulmonary arterial hypertension. [2018]
Intravenous prostacyclin-analogue therapy in pulmonary arterial hypertension - A review of the past, present and future. [2021]
Current epoprostenol use in patients with severe idiopathic, heritable or anorexigen-associated pulmonary arterial hypertension: data from the French pulmonary hypertension registry. [2014]
10.United Statespubmed.ncbi.nlm.nih.gov
Transition from parenteral prostacyclins to selexipag: safety and feasibility in selected patients. [2021]
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