Phase 1, Single Dose Study to Evaluate Safety, Pharmacokinetics, and Pharmacodynamics of MEDI5884

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy Volunteers

In brief

A Phase 1, single dose study with 4 cohorts of ascending doses and an optional Japanese cohort designed to evaluate the safety, pharmacokinetics, and pharmacodynamics of MEDI5884 in healthy volunteers

Key facts

Study ID: NCT03001297
Run by: MedImmune LLC
People needed: 64
Starts: 2017-01-17
Expected to finish: 2018-08-10
Last updated by the study team: 2018-08-22

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Healthy volunteers aged 18-55 years
Must provide written informed consent
Ability and willingness to adhere to the protocol
BMI 18-30kg/m2
Females not of childbearing potential
Males must practice 2 effective contraceptive measures if sexually active
Japanese descent for the Japanese cohort

You may not qualify if…

Any concurrent condition that in the opinion of the investigator would interfere with the evaluation of the investigational product
History or presence of gastrointestinal, renal, or hepatic disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs
Abnormal lab values, physical exam, vital signs
Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks prior to dosing
Positive Hepatitis B, Hepatitis C or HIV test
Receipt of investigational therapy with 4 months from screening
Current or previous use of systemic corticosteroids 60 days prior to dosing or lipid lowering medications 28 days prior to dosing
Abnormal ECG
Recent plasma or blood donation
Positive drug or alcohol screen.
Current smoker

Where it is running

Research Site — Glendale, California, United States

Full record on ClinicalTrials.gov

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