West Nile VirusPhase 1NCT00515385
A Trial to Evaluate the Safety of a Single Intravenous Infusion of MGAWN1 in Healthy Adults
A Phase 1 study testing MGAWN1 in people with West Nile Virus, run by MacroGenics at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- West Nile Virus
- What is being tested?
- MGAWN1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Jan 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
- The serum potassium must be within normal limits.
- Hemoglobin must be ≥12 mg/dl; ANC must be 1,500-upper limit of normal (ULN); platelets must be 130,000-500,000 μL; and sodium must be 130-150 moles/L.
- Each of these tests must not exceed the upper limit of normal: WBC, creatinine, and (provided asymptomatic) fasting blood glucose.
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- Bilirubin must be ≤ 2x ULN, ALT ≤ 1.25x ULN, and AST ≤1.25x ULN
- Urinalysis: glucose negative and protein ≤ 20 mg/dl.
- 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
Who cannot join
- 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
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- 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
- Subject is receiving any concomitant medication requiring a prescription, except for contraceptives
- Use of OTC preparations, herbal remedies or nutritional supplement (other than calcium and vitamin D) within the 7 days before study drug administration
- Subject has ongoing drug abuse/dependence (including alcohol); or recent history (over the past 5 years) of, or treatment for, alcohol or drug abuse
- Subject has a significant allergy to food or drugs
- Currently symptomatic seasonal allergies, or history of anaphylaxis, asthma, dermatographism or eczema
- Subject has any condition(s) that in the investigator's opinion would warrant exclusion from the study or prevent the subject from completing the study
- Subject is unable to understand spoken and/or written English or any other language in which a certified translation of the informed consent is available
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Double-Blind, Dose-Escalation Cohort Study to Evaluate the Safety, Tolerability and Pharmacokinetics of a Single Intravenous Infusion of MGAWN1, a Neutralizing, Humanized, Monoclonal Antibody (IgG1k) to West Nile Virus, in Healthy Adults
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.
- Conditions
- West Nile Virus
- Being tested
- MGAWN1, Placebo
- Keywords
- Randomized, Double-Blind, Dose-Escalation, Cohort Study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MGAWN1Drug
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
MGAWN1Drug
Single IV dose
PlaceboOther
Single IV dose
| Study group | Role | What they receive |
|---|---|---|
| 1a | Experimental | Cohort 1 completed Receives: Drug: MGAWN1 |
| 1b | Placebo comparator | Cohort 1 placebo completed Receives: Drug: MGAWN1; Other: Placebo |
| 2a | Experimental | Cohort 2 completed completed Receives: Drug: MGAWN1 |
| 2b | Placebo comparator | Cohort 2 placebo completed Receives: Drug: MGAWN1; Other: Placebo |
| 3a | Experimental | Cohort 3 active Receives: Drug: MGAWN1 |
| 3b | Placebo comparator | Cohort 3 placebo Receives: Drug: MGAWN1; Other: Placebo |
| 4a | Experimental | Cohort 4 active Receives: Drug: MGAWN1 |
| 4b | Placebo comparator | Cohort 4 placebo Receives: Drug: MGAWN1; Other: Placebo |
| 5a | Experimental | Cohort 5 active Receives: Drug: MGAWN1 |
| 5b | Placebo comparator | Cohort 5 placebo Receives: Drug: MGAWN1; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of adverse events and serious adverse events through the end of the study.
Measured: 6 months
Secondary outcomes (1)
The determination of pharmacokinetic (PK) parameters and immunogenicity of MGAWN1.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2007 (estimated)
- Study startAug 2007
- Primary completionDec 2008
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for West Nile VirusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- MacroGenics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00515385
- Sponsor's protocol ID
- CP-MGAWN1-01
- Other IDs
- DMID 06-0090
- Status last verified
- Feb 2022
- First submitted
- 9 Aug 2007
- Last updated
- 22 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Dose-Escalation Cohort Study to Evaluate the Safety, Tolerability and Pharmacokinetics of a Single Intravenous Infusion of MGAWN1, a Neutralizing, Humanized, Monoclonal Antibody (IgG1k) to West Nile Virus, in Healthy Adults
- ClinicalTrials.gov ID
- NCT00515385
- Acronym / sponsor ID
- CP-MGAWN1-01
- Conditions
- West Nile Virus
- Keywords
- Randomized, Double-Blind, Dose-Escalation, Cohort Study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- MacroGenicsIndustry (pharma, biotech, devices)
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Aug 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 13 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| 1a | Experimental | Drug: MGAWN1Cohort 1 completed |
| 1b | Placebo comparator | Drug: MGAWN1, Other: PlaceboCohort 1 placebo completed |
| 2a | Experimental | Drug: MGAWN1Cohort 2 completed completed |
| 2b | Placebo comparator | Drug: MGAWN1, Other: PlaceboCohort 2 placebo completed |
| 3a | Experimental | Drug: MGAWN1Cohort 3 active |
| 3b | Placebo comparator | Drug: MGAWN1, Other: PlaceboCohort 3 placebo |
| 4a | Experimental | Drug: MGAWN1Cohort 4 active |
| 4b | Placebo comparator | Drug: MGAWN1, Other: PlaceboCohort 4 placebo |
| 5a | Experimental | Drug: MGAWN1Cohort 5 active |
| 5b | Placebo comparator | Drug: MGAWN1, Other: PlaceboCohort 5 placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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)
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MGAWN1Eight 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 | Drug | 1a, 1b, 2a, 2b, 3a, 3b, 4a, 4b, 5a, 5b |
| MGAWN1Single IV dose | Drug | 1a, 2a, 3a, 4a, 5a |
| PlaceboSingle IV dose | Other | 1b, 2b, 3b, 4b, 5b |
Primary outcome
The incidence of adverse events and serious adverse events through the end of the study.
Time frame: 6 months
1 secondary outcome
The determination of pharmacokinetic (PK) parameters and immunogenicity of MGAWN1.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MGAWN1 in people with West Nile Virus, run by MacroGenics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of adverse events and serious adverse events through the end of the study. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2022.