A Phase 1 Study to Evaluate the Safety of MEDI7814 in Adult Volunteers

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy Subjects

In brief

This is a Phase 1 study to evaluate the safety and tolerability of single ascending intravenous doses of MEDI7814 in healthy adult subjects.

Key facts

Study ID

NCT01544361

Run by

MedImmune LLC

People needed

125

Starts

2012-01-01

Expected to finish

2012-09-01

Last updated by the study team

2014-07-23

Who can join

Age: 18 and older, up to 49. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Research Site — Omaha, Nebraska, United States

Full record on ClinicalTrials.gov

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