This study will investigate the safety and tolerability of SLN360 in patients with elevated Lp(a).
This first-in-human (FIH) study will investigate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of SLN360 after single ascending s.c. doses and multiple doses in healthy male and female subjects. Up to 9 cohorts of 88 patients with elevated Lp(a) will be enrolled. Each patient will receive single or multiple doses of SLN360 or placebo given by subcutaneous (s.c) injection.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
70
Jacksonville Center for Clinical Research Ltd.
Jacksonville, Florida, United States
Progressive Medical Research
Port Orange, Florida, United States
Metabolic and Atherosclerosis Research Center
Cincinnati, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Incidence of treatment-emergent adverse events
safety and tolerability will be reported separately following single-dose administration.
Time frame: Day 150
Incidence of treatment-emergent adverse events
safety and tolerability will be reported separately following multiple-dose administration.
Time frame: Day 201
Pharmacokinetic: peak plasma concentration (Cmax)
safety and tolerability will be reported separately following single-dose and multiple-dose administration.
Time frame: Day 150 and Day 201
Pharmacokinetic: area under the plasma concentration (AUC)
safety and tolerability will be reported separately following single-dose and multiple-dose administration.
Time frame: Day 150 and Day 201
Pharmacokinetic: apparent total clearance from plasma after s.c injection (CL/F)
safety and tolerability will be reported separately following single-dose and multiple-dose administration.
Time frame: Day 150 and Day 201
Pharmacodynamic: Change in Lp(a)
safety and tolerability will be reported separately following single-dose and multiple-dose administration.
Time frame: Day 150 and Day 201
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Linear Clinical Research
Perth, Western Australia, Australia
Monash Medical Centre
Clayton, Australia
Amsterdam Medical Centre
Amsterdam, Netherlands
Hammersmith Medicines Research
London, United Kingdom