Phase 1 Pulmonary Hypertension Trial, Recruiting NCT05967299 Sponsor: National Heart, Lung, and Blood Institute (NHLBI) Condition: Pulmonary Hypertension
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Phase 1 Pulmonary Hypertension Trial, Recruiting

NCT05967299
Recruiting Phase 1

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are willing to follow all study procedures and are available for the full duration of the study
  • You are male or female, between 18 and 60 years old (inclusive)
  • You are in good general health based on your medical history
  • If you are a woman who could become pregnant, you agree to use an accepted form of birth control throughout the study and for 120 days after receiving the study drug
  • If you are a man who is sexually active with a female partner, you agree to use a condom with spermicide for 120 days after receiving the study drug (or have been surgically sterile for at least 90 days before screening), and agree not to donate sperm for 120 days after receiving the study drug
  • You agree to follow certain lifestyle guidelines for the duration of the study
  • You are able to understand and are willing to sign a consent form

Who may not be able to join:

  • You are currently pregnant or breastfeeding
  • You have a history of HIV infection
  • You have a history of severe allergic reactions to drugs or their ingredients
  • You are known to be allergic to any ingredient in the study drug or placebo
  • You have had an infection or fever-related illness in the past 14 days
  • You have taken part in another clinical drug trial within the past 30 days (or longer, depending on the drug)
  • You have received any vaccine in the past 4 weeks, or a live vaccine (such as certain flu or travel vaccines) in the past 6 months
  • You have used tobacco products in the past 3 months
  • You have used illegal drugs (such as cocaine, opioids, methamphetamine, or PCP) in the past 6 months, or your drug screening test at your first visit comes back positive
  • You have used marijuana or cannabis in the past 30 days, or your drug screening test at your first visit comes back positive
  • You have a history of alcohol abuse in the past 2 years
  • You currently have a significant ongoing medical condition that is not well controlled, including conditions affecting the blood, kidneys, heart, lungs, liver, mental health, immune system, or other major body systems
  • Your body mass index (BMI) is below 17 or above 32 (confirm with trial site)
  • Your blood test results at your first screening visit show something significantly abnormal
  • Your heart tracing (ECG) shows signs of a significant heart condition
  • You have diabetes that requires medication
  • You have received another monoclonal antibody treatment (a specific type of medication) in the past 30 days
  • You have used herbal supplements or similar products in the past 2 weeks
  • You have donated 500 mL or more of blood in the past 2 months
  • The study doctor believes, for any other reason, that taking part could put you at increased risk

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Jason M Elinoff, M.D., National Heart, Lung, and Blood Institute (NHLBI)

Phone: (240) 328-0465

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 1
Registry
ClinicalTrials.gov
Start date
27 November 2023
Est. completion
1 September 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Safety and tolerability of ZMA001 in healthy subjects

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov