Study of Intravenous ZMA001 in Healthy Subjects
Pulmonary Arterial Hypertension PAH
About this trial
This is an interventional basic science trial for Pulmonary Arterial Hypertension PAH focused on measuring human monoclonal antibody (IgG1)
Eligibility Criteria
INCLUSION CRITERIA: 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 EXCLUSION CRITERIA: An individual who meets any of the following criteria prior to informed consent will be excluded from participation in this study: Pregnancy or lactation. Females of childbearing potential must have a negative serum B-human chorionic gonadotropin test no more than 48 hours from study drug infusion. History of severe drug or excipient allergy or hypersensitivity Known allergy to any of the components of the investigational drug or placebo Recent infection or febrile illness within the past 14 days Treatment with another investigational drug within the past 30 days or 5 half-lives, whichever is longer Any vaccination within the past 4 weeks or receipt of a live-attenuated vaccine within the past 6 months Use of tobacco products within the past 3 months Recreational drug use within the past 6 months or positive urine drug screen at Screening Visit History of alcohol abuse within the past 2 years History or current clinically significant medical illness including (but not limited to) hematologic, oncologic, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, infectious, hepatic, dermatologic, psychiatric, neurologic, autoimmune or allergic disease Use of prescription drugs (except contraceptives) within the past 7 days or 5 half-lives, whichever is longer. Common non-prescription medications such as (but not limited to) acetaminophen, ibuprofen, or anti-histamines are allowed up to 24 hours prior to dosing. Body mass index less than 17 or greater than 32 kg/m^2 Clinically significant abnormal results on clinical blood testing completed at the Screening Visit Electrocardiographic evidence of clinically relevant heart disease Use of vitamins, herbal supplements, or similar products within the past 2 weeks Blood donation equal to or above 500 mL within 2 months prior to dosing.
Sites / Locations
- National Institutes of Health Clinical Center
Arms of the Study
Arm 1
Arm 2
Placebo Comparator
Experimental
Placebo
ZMA001 (BC-NKA-20008)
Placebo for ZMA001 is supplied in a single-use 10 mL glass vial. Each vial contains 30 mg/mL of sucrose.Placebo drug is manufactured using the same ingredients as active drug (20 mM histidine-HCl buffer [pH 5.6], 30 mg/mL sucrose, 0.070 w/v% polysorbate 80) excluding ZMA001 antibody and is packed in the same vial.
ZMA001 is a fully human, monoclonal antibody (IgG1) that inhibits migration of activated monocytes and macrophages and reduces pulmonary vascular remodeling and pulmonary artery pressure in pre-clinical rodent models of pulmonary arterial hypertension (PAH).