A Phase 1 Single-Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Intravenous ZMA001 in Healthy Subjects
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.
∙ In order to be eligible to participate in this study, an individual must meet all of the following criteria:
⁃ Stated willingness to comply with all study procedures and availability for the duration of the study
⁃ Male\* or female, aged 18 to 60 years, inclusive
⁃ In good general health as evidenced by medical history
⁃ 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.
⁃ 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.
⁃ Agreement to adhere to Lifestyle Considerations throughout study duration
⁃ 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