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

NCT03001297 | Completed Phase 1

• 1 other identifier: D7870C00001
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteers

Keywords

atherosclerosis; acute coronary syndrome; MEDI5884

Outcome Measures

Primary Outcomes (5)

• Number of subjects with adverse events as a measure of safety and tolerability of MEDI5884

  Treatment emergent adverse events (TEAEs) and serious adverse events (TESAEs)

  Baseline until last follow-up visit, assessed up to 90 days post dose depending on cohort.

• Number of subjects with adverse events as a measure of safety and tolerability of MEDI5884

  12 lead electrocardiogram (ECG) including RR (The time between corresponding points on 2 consecutive R waves on ECG), PR (ECG interval measured from the onset of the P wave to the onset of the QRS complex) , QRS (ECG interval measured from the onset of the QRS complex to the J point) , QT (ECG interval measured from the onset of the QRS complex to the end of the T wave), and QTc (QT interval corrected for heart rate) intervals

  Baseline until last follow-up visit, assessed up to 90 days post dose depending on cohort.

• Number of subjects with adverse events as a measure of safety and tolerability of MEDI5884

  Vital signs (systolic and diastolic blood pressure, pulse rate, temperature, and respiratory rates)

  Baseline until last follow-up visit, assessed up to 90 days post dose depending on cohort.

• Number of subjects with adverse events as a measure of safety and tolerability of MEDI5884

  Clinical laboratory assessments (serum chemistry, hematology, and urinalysis)

  Baseline until last follow-up visit, assessed up to 90 days post dose depending on cohort.

• HDL-Cholesterol over time

  HDL-Cholesterol over time

  Baseline until last follow-up visit, assessed up to 90 days post dose depending on cohort.

Secondary Outcomes (14)

• Lipoprotein particle size

  Cohort 1: 28 days post dosing, Cohort 2: 45 days post dosing , Cohort 3: 60 days post dosing, Cohort 4: 90 days posting dosing, Optional Japanese American cohort: 60 days posting dosing

• Lipoprotein particle number

  Cohort 1: 28 days post dosing, Cohort 2: 45 days post dosing , Cohort 3: 60 days post dosing, Cohort 4: 90 days posting dosing, Optional Japanese American cohort: 60 days posting dosing

• Levels of total cholesterol

  Cohort 1: 28 days post dosing, Cohort 2: 45 days post dosing , Cohort 3: 60 days post dosing, Cohort 4: 90 days posting dosing, Optional Japanese American cohort: 60 days posting dosing

• Non-HDL-Cholesterol

  Cohort 1: 28 days post dosing, Cohort 2: 45 days post dosing , Cohort 3: 60 days post dosing, Cohort 4: 90 days posting dosing, Optional Japanese American cohort: 60 days posting dosing

• Low-density lipoprotein cholesterol (direct and Friedewald equation)

  Cohort 1: 28 days post dosing, Cohort 2: 45 days post dosing , Cohort 3: 60 days post dosing, Cohort 4: 90 days posting dosing, Optional Japanese American cohort: 60 days posting dosing

Study Arms (5)

MEDI5884 Dose 1

EXPERIMENTAL

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

Biological: MEDI5884 Dose 1

Placebo

PLACEBO COMPARATOR

Placebo will be administered subcutaneously (SC).

Biological: Placebo

MEDI5884 Dose 2

EXPERIMENTAL

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

Biological: MEDI5884 Dose 2

MEDI5884 Dose 3

EXPERIMENTAL

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

Biological: MEDI5884 Dose 3

MEDI5884 Dose 4

EXPERIMENTAL

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

Biological: MEDI5884 Dose 4

Interventions

Placebo BIOLOGICAL

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

Placebo

MEDI5884 Dose 1 BIOLOGICAL

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

MEDI5884 Dose 1

MEDI5884 Dose 2 BIOLOGICAL

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

MEDI5884 Dose 2

MEDI5884 Dose 3 BIOLOGICAL

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

MEDI5884 Dose 3

MEDI5884 Dose 4 BIOLOGICAL

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

MEDI5884 Dose 4

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• MedImmune LLC: lead

Study Sites (1)

Research Site

Glendale, California, 91206, United States

Location

MeSH Terms

Conditions

Atherosclerosis; Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Myocardial Ischemia; Heart Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2016
• First Posted: December 23, 2016
• Study Start: January 17, 2017
• Primary Completion: August 10, 2018
• Study Completion: August 10, 2018
• Last Updated: August 22, 2018

Record last verified: 2018-08

Locations

US (1)