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

MedImmune LLC133 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

133

Conditions

Stable Coronary Heart Disease

Interventions

MEDI5884DRUG

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.

PlaceboDRUG

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

Eligibility

Sex: ALLMin age: 45 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (23)

Research Site

Anniston, Alabama, United States

Research Site

Outcomes

Primary Outcomes

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.

Time frame: Day 1 (Baseline) through Day 241

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.

Time frame: Day 1 (Baseline) through Day 241

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.

Time frame: Day 1 (Baseline) through Day 241

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.

Data from ClinicalTrials.gov

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Secondary Outcomes

Change From Baseline in Apolipoprotein B

Change from baseline in apolipoprotein B is reported.

Time frame: Day 1 (Baseline), and Days 31, 61, and 91

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

Percent change from baseline in HDL-C is reported.

Time frame: Day 1 (Baseline), and Days 31, 61, and 91

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.

Time frame: Day 61 (pre-dose), and on Days 64, 68, 71, and 91

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

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

Time frame: Day 61 (pre-dose), and on Days 64, 68, 71, 91, 111, and 151

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.

Time frame: Day 61 (pre-dose), and on Days 64, 68, 71, 91, 111, and 151

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).

Time frame: Day 1 (pre-dose), on Day 8, Day 31 (pre-dose), Day 61 (pre-dose), on Days 151 and 241