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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-17

Study Completion Date

2018-08-10

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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MEDI5884 Dose 1

Participants will receive single dose of MEDI5884 Dose 1 injection SC on Day 1.

Group Type EXPERIMENTAL

MEDI5884 Dose 1

Intervention Type BIOLOGICAL

Participants will receive single dose MEDI5884 Dose 1 injection SC on Day 1.

Placebo

Placebo will be administered subcutaneously (SC).

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

Participants will receive single dose of placebo matched MEDI5884 injection SC on Day 1

MEDI5884 Dose 2

Participants will receive single dose of MEDI5884 Dose 2 injection SC on Day 1.

Group Type EXPERIMENTAL

MEDI5884 Dose 2

Intervention Type BIOLOGICAL

Participants will receive single dose MEDI5884 Dose 2 injection SC on Day 1

MEDI5884 Dose 3

Participants will receive single dose of MEDI5884 Dose 3 injection SC on Day 1.

Group Type EXPERIMENTAL

MEDI5884 Dose 3

Intervention Type BIOLOGICAL

Participants will receive single dose MEDI5884 Dose 3 injection SC on Day 1

MEDI5884 Dose 4

Participants will receive single dose of MEDI5884 Dose 4 injection SC on Day 1.

Group Type EXPERIMENTAL

MEDI5884 Dose 4

Intervention Type BIOLOGICAL

Participants will receive single dose MEDI5884 Dose 4 injection SC on Day 1

Interventions

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Placebo

Participants will receive single dose of placebo matched MEDI5884 injection SC on Day 1

Intervention Type BIOLOGICAL

MEDI5884 Dose 1

Participants will receive single dose MEDI5884 Dose 1 injection SC on Day 1.

Intervention Type BIOLOGICAL

MEDI5884 Dose 2

Participants will receive single dose MEDI5884 Dose 2 injection SC on Day 1

Intervention Type BIOLOGICAL

MEDI5884 Dose 3

Participants will receive single dose MEDI5884 Dose 3 injection SC on Day 1

Intervention Type BIOLOGICAL

MEDI5884 Dose 4

Participants will receive single dose MEDI5884 Dose 4 injection SC on Day 1

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes