Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as MEDI5884
MEDI5884 Dose 1 · 1 trial · 1 indication
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 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 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 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 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.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Participants will receive subcutaneous (SC) dose of placebo (volume matched to MEDI5884) on Days 1, 31, and 61. |
| MEDI5884 50 mg | EXPERIMENTAL | Participants will receive SC dose of MEDI5884 50 mg on Days 1, 31, and 61. |
| MEDI5884 100 mg | EXPERIMENTAL | Participants will receive SC dose of MEDI5884 100 mg on Days 1, 31, and 61. |
| MEDI5884 200 mg | EXPERIMENTAL | Participants will receive SC dose of MEDI5884 200 mg on Days 1, 31, and 61. |
| MEDI5884 350 mg | EXPERIMENTAL | Participants will receive SC dose of MEDI5884 350 mg on Days 1, 31, and 61. |
| MEDI5884 500 mg | EXPERIMENTAL | Participants will receive SC dose of MEDI5884 500 mg on Days 1, 31, and 61. |
| Name | Type | Description |
|---|---|---|
| MEDI5884 | DRUG | 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. |
| Placebo | DRUG | Participants will receive SC dose of placebo (volume matched to MEDI5884) on Days 1, 31, and 61. |
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/d...
MEDI5884 Dose 1 refers to a dose level of MEDI5884, an investigational small molecule developed by AstraZeneca PLC (ticker AZN). It was studied in adults with stable coronary heart disease. The compound is not approved and remains in clinical development.
MEDI5884 was evaluated in adults with stable coronary heart disease in a Phase 2 clinical trial. The study assessed safety, pharmacokinetics, and pharmacodynamic effects. It is an investigational agent and has not been approved for any indication.
MEDI5884 is developed by AstraZeneca PLC, which trades under the ticker AZN. The company sponsored the Phase 2 trial of the drug in stable coronary heart disease.
MEDI5884 is in Phase 2 development. One Phase 2 trial has been completed, and no active trials are ongoing. The drug is investigational and has not received FDA approval.
MEDI5884 has been studied in one completed Phase 2 trial, NCT03351738, titled a study to evaluate the safety, pharmacokinetics, and pharmacodynamic effects of MEDI5884 in adults with stable coronary heart disease. It enrolled 133 participants in the United States and was randomized, double-blind, and placebo-controlled.
Yes, MEDI5884 Dose 1 is a dose level of MEDI5884. The alternative name MEDI5884 refers to the same investigational compound developed by AstraZeneca PLC for stable coronary heart disease.