Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MEDI5884 · 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 is an investigational small molecule being studied for stable coronary heart disease. It has also been evaluated in healthy volunteers to assess its safety and pharmacological effects. The drug is in Phase 2 clinical development for the cardiovascular condition.
MEDI5884 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker symbol AZN. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with stable coronary heart disease.
MEDI5884 is currently in Phase 2 clinical development. A Phase 2 study has been completed in adults with stable coronary heart disease, and a Phase 1 study in healthy volunteers has also been completed. The drug is not yet approved and remains investigational.
MEDI5884 has been studied in two completed clinical trials. NCT03001297 was a Phase 1 single-dose study in healthy volunteers, and NCT03351738 was a Phase 2 study in adults with stable coronary heart disease. Both trials were conducted in the United States.
MEDI5884 is not FDA approved. It is an investigational drug that has completed Phase 1 and Phase 2 clinical trials, but it remains in clinical development. No approval status has been granted, and further studies may be needed to establish its safety and efficacy.