Study to Investigate Safety, Tolerability, PK and PD Response of SLN360 in Subjects With Elevated… (NCT04606602) | Clinical Trial Compass
CompletedPhase 1
Study to Investigate Safety, Tolerability, PK and PD Response of SLN360 in Subjects With Elevated Lipoprotein(a)
United States, Australia70 participantsStarted 2020-11-18
Plain-language summary
This study will investigate the safety and tolerability of SLN360 in patients with elevated Lp(a).
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria:
* Elevated plasma Lp(a) ≥ 150nmol/L.
* All subjects must agree to adhere to appropriate contraception requirements.
* Subjects must provide written informed consent and be able to comply with all study requirements.
* Body mass index of ≥ 18 kg/m2 and ≤ 45 kg/m2.
* For the MD part: confirmed history of stable atherosclerortic cardiovascular disease.
Exclusion criteria:
* Single Ascending Dose 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.
* Multiple Dose 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).
* Moderate or severe hepatic cirrhosis with Child-Pugh grade B or C, or other current or previous liver disease.
* Active serious mental illness or psychiatric disorder, including but not limited to schizophrenia, bipolar disorder, or severe depression requiring current pharmacological intervention.
* 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.
* Subjects with previous or current use of medication or therapies significantly affe…