RecruitingPhase 1

Study of Intravenous ZMA001 in Healthy Subjects

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 60 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 1 visit, 8 visits
  • Time periods mentioned: 16 weeks
  • Procedures mentioned: Blood draws, Physical exams, Urine samples

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "They will have a physical exam with blood tests."
  • "They will have a urine test for drug use."
  • "Participants will come to the clinic for 1 inpatient visit of up to 48 hours."
  • "After a screening visit, participants will have 1 inpatient visit and up to 8 outpatient visits over 16 weeks after receiving the treatment."
  • "Blood draws and other tests will be repeated."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how ZMA001 affects healthy adults ages 18 to 60. This is the first time the drug will be given to people, before testing it in people with high blood pressure in the lungs. Participants get one treatment through a vein and have follow-up visits over 16 weeks.

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 in Cohort 1 only. 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 in Cohort 1. Cohorts 2-4 will receive a single dose of the study drug, administered through a tube attached to a needle inserted into a vein in the arm. After a screening visit, participants will have 1 inpatient visit and up to 8 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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 18 to 60 years old and in good general health.
  • Be willing to follow study steps and lifestyle rules and attend all study visits.
  • Be able to understand the study and sign a form agreeing to take part.
  • Women who can become pregnant must use approved birth control during the study and for 120 days after treatment. Some methods must start at least 30 days before treatment.
  • Men who have sex with a female partner must use a condom with sperm-killing gel for 120 days after treatment, unless they had surgery to prevent pregnancy at least 90 days before screening.
  • Men must not donate sperm for 120 days after treatment.

Who can't join

  • Being pregnant or breastfeeding. Women who can become pregnant must have a negative blood pregnancy test within 48 hours before treatment.
  • A history of HIV, severe allergy to a drug or its ingredients, or a known allergy to the study drug or placebo ingredients. A placebo has no medicine.
  • An infection or illness with fever in the past 14 days; any vaccine in the past 4 weeks; or a vaccine with weakened live germs in the past 6 months.
  • Tobacco use in the past 3 months, illegal drug use in the past 6 months, marijuana use in the past 30 days, a positive urine drug test, or alcohol abuse in the past 2 years.
  • A serious illness not controlled by treatment, diabetes needing medicine, important abnormal blood tests, signs of heart disease on a heart test, or another finding that makes participation unsafe.
  • A body mass index (BMI), a measure based on height and weight, below 17 or above 32.
  • Another study drug in the past 30 days or longer if it stays in the body longer; another monoclonal antibody (a lab-made protein drug) in the past 30 days; or herbal supplements in the past 2 weeks.
  • Donating 500 milliliters of blood or more in the 2 months before treatment.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

* INCLUSION CRITERIA: In order to be eligible to participate in this study, an individual must meet all of the following criteria: 1. Stated willingness to comply with all study procedures and availability for the duration of the study 2. Male\* or female, aged 18 to 60 years, inclusive 3. In good general health as evidenced by medical history 4. Females of childbearing potential agree to use an accepted method of contraception (see below) throughout study participation and for 120 days after study drug infusion. 5. Males sexually active with a female partner must agree to use a condom with spermicide for 120 days after study drug infusion or be surgically sterile for at least 90 days before screening. Males must also agree to not donate sperm for 120 days after study drug administration. 6. Agreement to adhere to Lifestyle Considerations throughout study duration 7. Ability of subject to understand and the willingness to sign a written informed consent document. * Enrollment of healthy male subjects will be limited to no more than 14 out of the total study cohort of 32 in order to ensure an adequate representation of female subjects. Accepted methods of contraception for females of childbearing potential: * Use of an implanted or intrauterine hormonal device for at least 30 consecutive days before study drug infusion * Use of oral, patch or injectable contraceptives or a vaginal hormonal device for at least 30 consecutive days before study drug infusion * Use of a non-hormonal intrauterine device for at least 30 consecutive days before study drug infusion * Two barrier methods such as a diaphragm with spermicide or a condom with spermicide EXCLUSION CRITERIA: An individual who meets any of the following criteria prior to informed consent will be excluded from participation in this study: 1. Pregnancy or lactation. Females of childbearing potential must have a negative serum Beta-human chorionic gonadotropin test no more than 48 hours from study drug infusion. 2. A history of human immunodeficiency virus (HIV) infection. 3. History of severe drug or excipient allergy or hypersensitivity 4. Known allergy to any of the components of the investigational drug or placebo 5. Recent infection or febrile illness within the past 14 days 6. Treatment with another investigational drug within the past 30 days or 5 half-lives, whichever is longer 7. Any vaccination within the past 4 weeks or receipt of a live-attenuated vaccine within the past 6 months 8. Use of tobacco products within the past 3 months 9. Illicit drug use (e.g. cocaine, opioids, methamphetamine, PCP) within the past 6 months or positive urine drug screen at Screening Visit 10. Marijuana (cannabis) use within the past 30 days or positive urine drug screen at Screening Visit 11. History of alcohol abuse within the past 2 years 12. Current clinically significant medical illness that is uncontrolled despite appropriate medical treatment including (but not limited to) hematologic, oncologic, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, infectious, hepatic, dermatologic, psychiatric, neurologic, autoimmune or allergic disease 13. Body mass index less than 17 or greater than 32 kg/m\^2 14. Clinically significant abnormal results on clinical blood testing completed at the Screening Visit 15. Electrocardiographic evidence of clinically relevant heart disease 16. Diabetes mellitus requiring medical treatment 17. Received another monoclonal antibody in the past 30 days 18. Use of herbal supplements, or similar products within the past 2 weeks 19. Blood donation equal to or above 500 mL within 2 months prior to dosing. 20. Any other finding that, in the judgment of the Investigator, would increase the risk of having an adverse outcome from participating in the study. Justification to exclude minors: Given that the vast majority of patients with PAH are \>18 years of age and the fact that this is a first in human study, the risks of including children/minors (ie. subjects \< 18 yrs of age) are not justified given the limited potential benefits of including these subjects. Justification to exclude adults \>60 years old: Subjects \> 60 years of age are more likely to have comorbid medical conditions that could place them at increased risk of participation.

Study sites (1)

MD