Actively Recruiting
Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Intravenous ZMA001 in Healthy Adults
Led by National Heart, Lung, and Blood Institute (NHLBI) · Updated on 2026-06-05
96
Participants Needed
1
Research Sites
12 weeks
Total Duration
On this page
Sponsors
N
National Heart, Lung, and Blood Institute (NHLBI)
Lead Sponsor
Z
Zymedi, Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Pulmonary arterial hypertension (PAH) is a serious lung condition that can result from various diseases and often leads to a short survival time. Researchers are studying a new drug called ZMA001, a monoclonal antibody, to understand its effects. This trial is the first time ZMA001 will be given to healthy adult volunteers to assess its safety and how the body processes the drug. Participants in this study will receive a single intravenous dose of ZMA001 or a placebo during an inpatient visit lasting up to 48 hours. The study includes multiple groups, with the first group including both placebo and drug recipients, while later groups receive only the drug. Following the initial dose, participants will attend up to eight outpatient visits over 16 weeks for further monitoring and testing. During the trial, each participant will undergo screening that includes physical exams, blood and urine tests, and heart function assessments. After dosing, blood samples and other tests will be conducted at scheduled times to track safety, drug levels, and how long the drug stays in the body. The main focus is to evaluate any side effects and how well the drug is tolerated up to 113 days after treatment, with ongoing monitoring throughout the study period.
CONDITIONS
Brief Title
Study of Intravenous ZMA001 in Healthy Subjects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willingness to comply with all study procedures and availability for the study duration
- Male or female aged 18 to 60 years
- In good general health based on medical history
- Females of childbearing potential agree to use accepted contraception throughout the study and for 120 days after drug infusion
- Males sexually active with a female partner agree to use a condom with spermicide for 120 days after drug infusion or be surgically sterile for at least 90 days prior
- Agreement to adhere to lifestyle considerations during the study
- Ability to understand and willingness to sign informed consent
You will not qualify if you...
- Pregnancy or lactation; females must have a negative pregnancy test within 48 hours of drug infusion
- History of HIV infection
- History of severe allergies or hypersensitivity to study drug components
- Recent infection or fever within 14 days
- Use of another investigational drug within 30 days or 5 half-lives
- Vaccination within 4 weeks or live vaccine within 6 months
- Use of tobacco in past 3 months
- Use of illicit drugs or positive drug screen within 6 months
- Marijuana use or positive drug screen within 30 days
- History of alcohol abuse in past 2 years
- Significant uncontrolled medical illnesses
- Body mass index under 17 or over 32 kg/m²
- Abnormal blood test results at screening
- Heart disease detected by ECG
- Diabetes requiring treatment
- Use of monoclonal antibodies in past 30 days
- Use of herbal supplements in past 2 weeks
- Blood donation of 500 mL or more within 2 months prior to dosing
- Any other condition increasing risk of adverse outcome as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 113 days
Participants receive a single intravenous dose of ZMA001 or placebo and are monitored for safety, tolerability, and pharmacokinetics.
1 infusion visit with multiple follow-up visits at 2, 4, 8, 12, 24, and 48 hours; Days 8, 15, 22, 29, 57, 85, and 113
Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
S
Sandra Cooper Bennett, R.N.
J
Jason M Elinoff, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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