A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamic Effects of MEDI5884 in Adults With Stable Coronary Heart Disease

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

MEDI5884

Placebo

About this trial

This is an interventional treatment trial for Stable Coronary Heart Disease focused on measuring Coronary heart disease, Pharmacokinetic, Pharmacodynamics

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Diagnosis of stable coronary heart disease prior to screening
Currently receiving high intensity statin(s)

Exclusion Criteria:

Unstable cardiovascular conditions
Any planned arterial revascularizations
Fasting Laboratory values at screening: Triglycerides > 500 mg/dl, Low Density Lipoprotein-Cholesterol > 100 mg/dL
Any disease or condition or laboratory value that would place the participant at an unacceptable risk.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

MEDI5884 50 mg

MEDI5884 100 mg

MEDI5884 200 mg

MEDI5884 350 mg

MEDI5884 500 mg

Arm Description

Participants will receive subcutaneous (SC) dose of placebo (volume matched to MEDI5884) on Days 1, 31, and 61.

Participants will receive SC dose of MEDI5884 50 mg on Days 1, 31, and 61.

Participants will receive SC dose of MEDI5884 100 mg on Days 1, 31, and 61.

Participants will receive SC dose of MEDI5884 200 mg on Days 1, 31, and 61.

Participants will receive SC dose of MEDI5884 350 mg on Days 1, 31, and 61.

Participants will receive SC dose of MEDI5884 500 mg on Days 1, 31, and 61.

Outcomes

Primary Outcome Measures

Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)

An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.

Number of Participants With Clinically Important Changes in Electrocardiograms (ECGs) From Baseline

Number of participants with clinically important changes in ECGs from baseline are reported. Clinically important changes in ECGs is defined as any clinical significant difference in heart rate, RR interval, PR interval, QRS, and QT intervals from the primary lead of the digital 12-lead ECG from baseline.

Number of Participants With Clinically Important Changes in Vital Signs From Baseline

Number of participants with clinically important changes in vital signs from baseline are reported. Vital signs measurements were obtained after the participant had rested in the supine position for at least 10 minutes at the recording time. Clinically important changes in vital signs from baseline is defined as any clinical significant difference in the vital sign parameters (blood pressure, heart rate, body temperature, and respiratory rate) from baseline.

Number of Participants With Clinically Important Changes in Laboratory Parameters From Baseline

Number of participants with clinically important changes in laboratory parameters from baseline are reported. Clinically important changes in laboratory parameters is defined as any clinical significant difference in analysis of serum chemistry, hematology, and urine from baseline.

Number of Participants With Clinically Important Changes in Physical Examinations From Baseline

Number of participants with clinically important changes in physical examinations from baseline are reported. Clinically important changes in physical examinations is defined as any clinical significant difference in general appearance, head, ears, eyes, nose, throat, neck, skin, heart, lung, abdomen, musculoskeletal system, endocrine system, nervous system, height, and weight from baseline.

Secondary Outcome Measures

Change From Baseline in Apolipoprotein B

Change from baseline in apolipoprotein B is reported.

Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C)

Percent change from baseline in HDL-C is reported.

Area Under the Concentration-time Curve for 30 Days (AUC30d) After the Last Dose of MEDI5884

AUC30d after the last dose of MEDI5884 is reported.

Maximum Observed Serum Concentration (Cmax) of MEDI5884 After the Last Dose

Maximum observed serum concentration (Cmax) of MEDI5884 after the last dose is reported.

Terminal Elimination Half-life (t½) of MEDI5884 After the Last Dose

Terminal half-life is the time required for the plasma concentration to fall by 50% during the terminal phase. The t½ of MEDI5884 after the last dose is reported.

Number of Participants With Treatment-emergent Anti-drug Antibodies (ADA) to MEDI5884

Treatment-emergent ADA is defined as the sum of treatment-induced ADA (post baseline-positive only) and treatment-boosted ADA (baseline ADA titer that was boosted to a 4-fold or higher level following drug administration).

Full Information

NCT ID

NCT03351738

First Posted

October 12, 2017

Last Updated

March 10, 2020

Sponsor

MedImmune LLC

1. Study Identification

Unique Protocol Identification Number

NCT03351738

Brief Title

A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamic Effects of MEDI5884 in Adults With Stable Coronary Heart Disease

Official Title

A Phase 2a Randomized, Double-blind, Placebo-controlled, Parallel-designed Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamic Effects of MEDI5884 in Subjects With Stable Coronary Heart Disease

Study Type

Interventional

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Completed

Study Start Date

December 13, 2017 (Actual)

Primary Completion Date

November 9, 2018 (Actual)

Study Completion Date

November 9, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

MedImmune LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

Brief Summary

A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamic Effects of MEDI5884 in Adults With Stable Coronary Heart Disease.

Detailed Description

A Randomized, Double-blind, Placebo-controlled, Parallel-designed Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamic Effects of MEDI5884 in Participants with Stable Coronary Heart Disease.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stable Coronary Heart Disease

Keywords

Coronary heart disease, Pharmacokinetic, Pharmacodynamics

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

133 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Participants will receive subcutaneous (SC) dose of placebo (volume matched to MEDI5884) on Days 1, 31, and 61.

Arm Title

MEDI5884 50 mg

Arm Type

Experimental

Arm Description

Participants will receive SC dose of MEDI5884 50 mg on Days 1, 31, and 61.

Arm Title

MEDI5884 100 mg

Arm Type

Experimental

Arm Description

Participants will receive SC dose of MEDI5884 100 mg on Days 1, 31, and 61.

Arm Title

MEDI5884 200 mg

Arm Type

Experimental

Arm Description

Participants will receive SC dose of MEDI5884 200 mg on Days 1, 31, and 61.

Arm Title

MEDI5884 350 mg

Arm Type

Experimental

Arm Description

Participants will receive SC dose of MEDI5884 350 mg on Days 1, 31, and 61.

Arm Title

MEDI5884 500 mg

Arm Type

Experimental

Arm Description

Participants will receive SC dose of MEDI5884 500 mg on Days 1, 31, and 61.

Intervention Type

Drug

Intervention Name(s)

MEDI5884

Intervention Description

Participants will receive SC dose of MEDI5884 50 mg or 100 mg or 200 mg or 350 mg or 500 mg on Days 1, 31, and 61.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Participants will receive SC dose of placebo (volume matched to MEDI5884) on Days 1, 31, and 61.

Primary Outcome Measure Information:

Title

Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)

Description

An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.

Time Frame