NL-OMON55119已完成不适用
A randomized, double-blind, placebo controlled, first in human study to investigate the safety, tolerability, and pharmacokinetic and pharmacodynamic response of SLN360 in subjects with elevated lipoprotein (a) - APOLLO
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •i. Male and female subjects aged 18 years to 70 years.
- •ii. Body mass index of >= 18 kg/m2 and <= 45 kg/m2.
- •iii. Women of childbearing potential (WOCBP) must have a negative serum
- •pregnancy test at screening and a negative pregnancy test (serum or urine) on
- •iv. All subjects must agree to adhere to appropriate contraception requirements
- •(acceptable methods of contraception are summarized below and described in
- •detail in the protocol), as follows:
- •a. WOCBP must agree to use 1 highly effective method of contraception, from the
- •beginning of the screening period until 3 months after the last administration
- •of study drug.
- •b. Male subjects must use a male condom (with or without spermicide) if
- •sexually active with a female of child-bearing potential from the start of the
- •screening period until 3 months after the last administration of study drug.
- •v. Male subjects are not allowed to donate sperm and female subjects are not
- •allowed to donate eggs from the beginning of the screening period until 3
- •months following the last administration of SLN360.
- •vi. Subjects must provide written informed consent and be willing and able to
- •comply with all study requirements.
- •vii. Elevated plasma Lp(a) = 150nmol/L
- •viii. For the MD part only: confirmed history of stable atherosclerortic
- •cardiovascular disease (including, but not limited to, coronary artery disease
- •with or without myocardial infarction, previous coronary revascularization with
- •percutaneous coronary intervention (PCI) or coronary artery bypass grafting
- •(CABG), ischaemic stroke, clinically important carotid artery stenosis,
- •peripheral arterial disease). 'Stable' is defined as the absence of acute
- •cardiovascular disease events within 6 months of screening (including, but not
- •limited to, acute myocardial infarction, unstable angina, acute stroke, acute
- •limb ischaemia).
排除标准
- •i. Comorbidity;
- •a. For the SAD part only: any history of clinically overt cardiovascular
- •disease, defined as acute coronary syndromes, myocardial infarction, stable
- •angina, coronary or other revascularization, ischemic stroke or transient
- •ischemic attack and atherosclerotic peripheral arterial disease.
- •b. For the MD part only: recent history of acute cardiovascular disease events
- •within 6 months of screening (including, but not limited to, acute myocardial
- •infarction, unstable angina, acute stroke and acute limb ischemia).
- •c. Any uncontrolled or serious disease, or any medical or surgical condition
- •including evidence of unstable cardiovascular disease, that may interfere with
- •participation in the clinical study, significantly interfere with the
- •interpretation of the results and/or put the subject at significant risk
- •(according to Investigator*s judgement) if he/she participates in the clinical
- •d. Moderate or severe hepatic cirrhosis with Child-Pugh grade B or C, or other
- •current or previous liver disease that may increase the risk of drug-induced
- •liver injury or influence the pharmacology of SLN360.
- •e. Active serious mental illness or psychiatric disorder, including but not
- •limited to schizophrenia, bipolar disorder, or severe depression requiring
- •current pharmacological intervention.
- •f. Clinically significant illness within 7 days before the first dose of study
- •g. Any conditions which, in the opinion of the Investigator, would make the
- •subject unsuitable for enrolment in the study or could interfere with the
- •subject*s participation in, or completion of the study.
- •h. Positive nucleic acid test for SARS-CoV-2 (the virus causing Covid-19)
- •during screening.
- •i. Positive test for hepatitis B surface antigen (HBsAg), hepatitis B core
- •antibody (anti HBC), hepatitis C virus antibody (HCV Ab) or human
- •immunodeficiency virus (HIV).
- •ii. Biochemical and hematological parameters:
- •a. Clinically significant abnormalities in screening blood tests (excluding
- •lipid profile) that are judged to affect the suitability for inclusion,
- •i. ALT or AST >1.5 × ULN.
- •ii. Total bilirubin > ULN, except in previously confirmed cases of Gilbert*s
- •iii. Platelet count < lower limit of the normal range.
- •iv. Significant renal impairment before randomization, defined as estimated
- •glomerular filtration rate (using the Chronic Kidney Disease Epidemiology
- •Collaboration equation) <60 mL/min/1.73 m.
- •v. Haemoglobin A1c greater than 6.5% (47.5mmol/mol) in subjects without
- •diabetes mellitus, or haemoglobin A1c greater than 8.5% (69.4mmol/mol) in
- •subjects with diabetes mellitus and on appropriate diabetes treatment.
- •iii. Concomitant medication:
- •Subjects with previous or current use of the following therapies are not
- •eligible for participation:
- •a. Medication or therapies significantly affecting Lp(a) level (including but
- •not restricted to PCSK9 inhibitors, prescription dose niacin, fibrates or
- •anti-estrogen therapy), unless on a stable dose or off treatment for >= 8 weeks
- •prior to screening and no planned medication or dose adjustment during the
- •b. Statins and/or ezetimibe unless on a stable dose or off treatment for at
- •least 8 weeks prior to screening and no planned medication or dose adjustment
- •during the study.
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