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Intravenous ZMA001 for Pulmonary Arterial Hypertension
Phase 1
Recruiting
Led By Jason M Elinoff, M.D.
Research Sponsored by National Heart, Lung, and Blood Institute (NHLBI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male* or female, aged 18 to 60 years, inclusive
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-infusion, end of infusion, 2, 4, 8, 12, 24, and 48h; days 8, 29, 57, 85 and 113
Awards & highlights
Study Summary
This trial tests a potential new drug (ZMA001) on healthy volunteers to see if it's safe and effective for a lung disease (PAH). Participants will receive one dose of the drug or a placebo and follow-up visits over 16 weeks.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since this is the first test of ZMA001 in humans, specific side effects aren't known yet. Generally, monoclonal antibodies can cause allergic reactions, infusion site discomfort, feverish symptoms or body aches.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 60 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ pre-infusion, end of infusion, 2, 4, 8, 12, 24, and 48h; days 8, 29, 57, 85 and 113
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-infusion, end of infusion, 2, 4, 8, 12, 24, and 48h; days 8, 29, 57, 85 and 113
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety and tolerability of ZMA001 in healthy subjects
Secondary outcome measures
Determine the pharmacokinetics of ZMA001 in healthy subjects following a single, intravenous dose.
Trial Design
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.
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Zymedi, Co., Ltd.UNKNOWN
National Heart, Lung, and Blood Institute (NHLBI)Lead Sponsor
3,840 Previous Clinical Trials
47,852,028 Total Patients Enrolled
25 Trials studying Pulmonary Arterial Hypertension
3,055 Patients Enrolled for Pulmonary Arterial Hypertension
Jason M Elinoff, M.D.Principal InvestigatorNational Heart, Lung, and Blood Institute (NHLBI)
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had a fever or infection in the last 2 weeks.My BMI is either below 17 or above 32.I am a man who will use a condom or am surgically sterile, and won't donate sperm for 120 days after treatment.I have been using approved birth control methods for at least 30 days.I have a significant ongoing medical condition.I am a healthy male, and there's a limit on male participants in the study.I haven't taken any prescription drugs (except for birth control) in the past week or longer.You have used tobacco products in the last 3 months.I agree to use birth control during the study and for 4 months after.I have used vitamins or herbal supplements in the last 2 weeks.I am between 18 and 60 years old.I haven't had any vaccines in the last 4 weeks or live vaccines in 6 months.I have not donated blood (500 mL or more) in the last 2 months.You have had a problem with drinking too much alcohol in the last 2 years.You have a heart condition that shows up on an electrocardiogram.Your blood test results from the screening visit show a significant health issue.You have used drugs for fun in the past 6 months or your urine test shows that you have used drugs recently.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: ZMA001 (BC-NKA-20008)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are individuals below the age of 25 being considered for participating in this investigation?
"Within this medical study, only those aged 18 - 60 are eligible for participation."
Answered by AI
Has ZMA001 (BC-NKA-20008) earned a blessing from the FDA?
"Our assessment at Power rated ZMA001 (BC-NKA-20008) a 1 as this Phase 1 trial lacks conclusive evidence in regards to safety and efficacy."
Answered by AI
Does my profile meet the criteria to take part in this investigation?
"Individuals suffering from pulmonary arterial hypertension between 18 and 60 years old have the opportunity to join this clinical trial, which is aiming to recruit 96 participants."
Answered by AI
Are there any vacancies in this clinical trial for new participants?
"According to information hosted on clinicaltrials.gov, this study is no longer actively seeking candidates. Initially posted on August 7th 2023 and last updated with edits on August 1st 2023, it has since gone inactive though there are 86 alternative trials that remain open for recruitment."
Answered by AI
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