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| ID | Type | Description | Link |
|---|---|---|---|
| DMID 06-0090 |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1a | Experimental | Cohort 1 completed |
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| 1b | Placebo Comparator | Cohort 1 placebo completed |
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| 2a | Experimental | Cohort 2 completed completed |
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| 2b | Placebo Comparator | Cohort 2 placebo completed |
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| 3a | Experimental | Cohort 3 active |
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| 3b | Placebo Comparator | Cohort 3 placebo |
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| 4a |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MGAWN1 | Drug | Eight subjects per cohort, each receives a single IV infusion of MGAWN1 of saline control on study day 0 (6 MGAWN1, 2 saline control. Cohort 1 - 0.3 mg/kg Cohort 2 - 1 mg/kg Cohort 3 - 3 mg/kg Cohort 4 - 10 mg/kg Cohort 5 - 30 mg/kg |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of adverse events and serious adverse events through the end of the study. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| The determination of pharmacokinetic (PK) parameters and immunogenicity of MGAWN1. | 6 months |
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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
Subject is a non-smoker, i.e., has refrained from any tobacco usage, including smokeless tobacco, nicotine patches, etc. for 6 months before study entry
Subject's normal alcohol consumption does not exceed 3 units per day if male or does not exceed 2 units per day if female. Both male and female subjects will be permitted to consume no more than 2 units of alcohol per day throughout the study. (One unit of alcohol is equivalent to 1 ounce of hard liquor, or 4 ounces of wine, or 12 ounces of beer.)
Willing to forego other forms of experimental treatment during the study
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PAREXEL Phase 1 Unit | Baltimore | Maryland | 21225 | United States |
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| Experimental |
Cohort 4 active |
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| 4b | Placebo Comparator | Cohort 4 placebo |
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| 5a | Experimental | Cohort 5 active |
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| 5b | Placebo Comparator | Cohort 5 placebo |
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| MGAWN1 | Drug | Single IV dose |
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| Placebo | Other | Single IV dose |
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