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 |
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
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.
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
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