A Trial to Evaluate the Safety of a Single Intravenous Infusion of MGAWN1 in Healthy Adults (NCT00515385) | Clinical Trial Compass
CompletedPhase 1
A Trial to Evaluate the Safety of a Single Intravenous Infusion of MGAWN1 in Healthy Adults
United States40 participantsStarted 2007-08
Plain-language summary
The primary purpose of this phase 1, double-blind, cohort study is to evaluate the safety, tolerability, and pharmacokinetics of escalating doses of MGAWN1 administered as a single intravenous (IV) infusion to healthy adults. Subjects will be enrolled sequentially into one of 5 dose-level cohorts, with 8 subjects in each cohort. Six subjects in each cohort will receive MGAWN1 (a Neutralizing, Humanized, Monoclonal Antibody (IgG1k) to West Nile Virus) and 2 will receive a saline control.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Written informed consent obtained from the subject including consent for the use of research-related health information, before performance of any study-related procedure including screening procedures
✓. Healthy adult male or female subjects aged 18-65 years, with a body mass index (BMI) of 18-32 kg/m2
✓. Subjects must be physically healthy as determined by the investigator based on medical history, physical examination, ECG, and clinical laboratory tests within laboratory normal ranges. To be considered normal, the following results must pertain:
✓. Have adequate venous access
✓. Have negative assays for human immunodeficiency virus (HIV), hepatitis B virus (HBsAg) and hepatitis C virus (HCV)
✓. Women of childbearing potential will not be breastfeeding and will have a negative serum pregnancy test within 21 days of study drug administration as well as on Study Day -1
✓. Women of childbearing potential (including peri-menopausal women who have had a menstrual period within 1 year of enrollment) must be using appropriate birth control (defined as a method with low failure rate, i.e., less than 1% per year, when used consistently and correctly such as implants, injectables, some intrauterine contraceptive devices, sexual abstinence, or a vasectomized partner) during the entire duration of study participation. Use of contraceptive medications is allowed during the study. Women who have undergone a total hysterectomy or are postmenopausal are eligible.
✓. In the opinion of the investigator, the subject is capable of understanding and complying with the protocol
Exclusion criteria
What they're measuring
1
The incidence of adverse events and serious adverse events through the end of the study.
✕. Subject is unwilling or unable to comply with the protocol during the study period or to cooperate fully with the investigator or the site personnel
✕. Subject has a significant organ abnormality or disease
✕. Subject is considering or scheduled to have any surgical procedure during the duration of the study
✕. Subject has an active malignancy or history of solid, metastatic, or hematologic malignancy with the exception of basal or squamous cell carcinoma of the skin that has been removed
✕. Subject has donated or lost more than a unit of blood within 30 days before screening
✕. Subject has a positive qualitative urine drug test at screening or an abnormal blood alcohol test (≥ 10mg/dL) on Study Day -1
✕. Subject has received any other investigational drug or investigational biologically derived pharmaceutical agent within 60 days before screening
✕. Subject has a history of seizure, chronic headache, viral encephalitis, or clinically significant infection (including viral) in the 14 days before dosing