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A Phase 1 Randomized, Double-Blind, Placebo-Controlled, Single-Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Intravenous ZMA001 in Healthy Subjects

Are You Healthy? Join the Fight Against Pulmonary Arterial Hypertension

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Pulmonary Arterial Hypertension (PAH) is associated with high blood pressure in the lungs due to narrowing of the small pulmonary arteries. The condition worsens over time. However, medications and oxygen therapy can help lessen the symptoms and improve the quality of life. The PAH team at the National Heart, Lung, and Blood Institute are testing the safety, tolerability, and effects of an investigational drug (ZMA001) that may help reduce blood pressure in the lungs to treat PAH. ZMA001 is in a class of drugs called monoclonal antibodies. The results of this work may determine an appropriate dose for PAH patients in the future.

You can participate if you are:

  • 18-60 years old in good general health
  • Willing to use an accepted method of contraception during the duration of the study
  • Not pregnant or breastfeeding

What is involved:

  • An initial screening visit
  • An inpatient stay at the NIH Clinical Center to receive a single IV infusion
  • Approximately 5 outpatient follow-up visits with blood work
  • Study participation lasts about 16 weeks

Compensation up to $2,170 may be provided upon completion of study, based on study-related tasks.

The NIH Clinical Center, America's Research Hospital, is located in Bethesda, MD, on the Metro Red Line (Medical Center stop).

For more information:
NIH Clinical Center Office of Patient Recruitment
800-411-1222
TTY users dial 7-1-1
Email: ccopr@nih.gov

Or go online:
https://go.nih.gov/B39Ou2h
Refer to NIH study # 001522-H

Department of Health and Human Services
National Institutes of Health Clinical Center (CC)
National Heart, Lung and Blood Institute (NHLBI)