Healthy Subjects Clinical Trial
Official title:
A Phase 1, Randomized, Placebo-controlled, Single-dose Study to Evaluate the Safety of MEDI7814 in Adult Volunteers
Verified date | June 2014 |
Source | MedImmune LLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
This is a Phase 1 study to evaluate the safety and tolerability of single ascending intravenous doses of MEDI7814 in healthy adult subjects.
Status | Completed |
Enrollment | 125 |
Est. completion date | September 2012 |
Est. primary completion date | September 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 49 Years |
Eligibility |
Inclusion Criteria: - Aged 18 years up to and including 49 years at the time of first dose of investigational product - Healthy by medical history, physical examination, and laboratory studies - Body weight 50-125 kilogram (kg); body mass index 19.0-32.0 kilogram per square meter (kg/m^2) (inclusive) - Females must be of non-childbearing potential. Exclusion criteria: - Any acute illness within 30 days of screening - Concurrent enrollment in another clinical trial - The subject has a positive drug/alcohol screen at screening or Day -1 - Pregnancy - Current cigarette smokers - History of cancer other than non-melanoma skin cancer or in situ carcinoma of the cervix treated with apparent success - Use of immunosuppressive medications - Subjects who have an unresolved infection with any Neisseria species - Subjects who have had their spleen removed for any reason. |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Research Site | Omaha | Nebraska |
Lead Sponsor | Collaborator |
---|---|
MedImmune LLC |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between administration of study drug and up to Day 106 that were absent before treatment or that worsened relative to pretreatment state. AEs included SAEs as well as non-serious AEs which occurred during the trial. | Day 1 to Day 106 | Yes |
Secondary | Pharmacokinetic (PK) Parameters of MEDI7814 | Individual MEDI7814 plasma concentration data and descriptive statistics of the PK parameters were to be tabulated by treatment group. Non-compartmental PK data analysis were to be performed for MEDI7814-treated participants to estimate PK parameters if data allowed. | Predose, end of infusion, 2, 6, 12 hours post-end of infusion on Day 1; Day 2, 3, 5, 8, 15, 22, 29, 43, 57, 85, and 106 | No |
Secondary | Number of Participants With Anti-Drug Antibodies (ADAs) for MEDI7814 | Day 1, 29, 57, 85, and 106 | No |
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