A Phase I, Randomized, Double-Blind, Placebo Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 986 in Healthy Subjects and Heart Failure Patients - 20150183

Amgen0 个研究点目标入组 4 人开始时间: 待定最近更新: 2024年4月15日

适应症

试验速览

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•Criteria for HFrEF- Patients between the ages of 18 and 85 years with stable NYHA class
•II or III chronic HF in sinus rhythm on optimal therapy and a left ventricular ejection
•fraction of < 40% and NT-proBNP level of > 250 pg/mL.
•* Criteria for HFpEF- Patients between the ages of 18 and 85 years with stable NYHA
•class II or III chronic HF, in sinus rhythm on optimal standard of care therapy with a left
•ventricular ejection fraction of > 50% and NT-proBNP level of > 250 pg/mL.

•*Heart rate * 100 beats per minute after 5 minutes of rest or an untreated symptomatic bradyarrhythmia within 1 month prior to enrollment.
•*Severe uncorrected valvular heart disease, or hypertrophic obstructive
•cardiomyopathy, active myocarditis, constrictive pericarditis, or clinically
•significant congenital heart disease.
•*Estimated glomerular filtration rate (eGFR)
•within the screening period of less than 30 mL/min/1.732m2 as calculated using
•the Modification of Diet in Renal Disease (MDRD) formula.
•*For subjects in Part C of the study: Systolic blood pressure > 160 mm Hg or <
•100 mm Hg, or diastolic blood pressure > 110 mm Hg or < 60 mm Hg, assessed
•on 2 separate occasions prior to enrollment.
•*For subjects in Part C of the study: Troponin I > ULN if there is also evidence of
•an acute cardiovascular event.

发起方