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



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 55
Updated:8/24/2018
Start Date:January 17, 2017
End Date:August 10, 2018

Use our guide to learn which trials are right for you!

A Phase 1 Randomized, Blinded, Placebo-controlled Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Single-Ascending Doses of MEDI5884 in Healthy Volunteers

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

This is a first time in human, phase 1, randomized, blinded, placebo-controlled study to
evaluate the safety, pharmacokinetics and pharmacodynamics of single ascending subcutaneous
doses of MEDI5884 in healthy volunteers (age 18-55). The study consists of 4 cohorts of
increasing doses (8 subjects each) and an optional Japanese American cohort (24 subjects) for
a total of 56 healthy subjects. The decision whether or not to dose escalate will be based
upon data review by the Dose Escalation Committee. Subjects will be randomized 3:1 to
MEDI5884 or placebo. Following screening, the study consists of a 3 day inpatient stay and
follow up visits. The number of follow up visits depend on the cohort assigned.

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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
We found this trial at
1
site
?
mi
from
Glendale, CA
Click here to add this to my saved trials