This is a Phase 1, multi-center, randomized, double-blinded, placebo-controlled single and multiple dose escalation study with SC doses of SNK-396 in participants with elevated LDL-C. The study will be divided into two parts: * SAD cohorts * MAD cohorts
The SAD part will consist of up to 8 cohorts of eligible participants with elevated LDL-C as defined as serum LDL levels between 2.6 - 4.9 mmol/L (inclusive) The MAD part will consist of up to 8 cohorts of eligible participants with elevated LDL-C as defined as serum LDL levels between 2.6 - 4.9 mmol/L (inclusive)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
41
A single dose of SNK-396 within the dose range of 25 to 800 mg, or matching placebo.
Multiple doses of SNK-396 within the dose range of from 25 to 800 mg, or matching placebo.
Nucleus Network Pty Ltd
Herston, Queensland, Australia
Cmax Clinical Research
Adelaide, South Australia, Australia
Nucleus Network Pty Ltd
Melbourne, Victoria, Australia
Treatment emergent adverse events
Number of Subjects with Treatment Emergent Adverse Events
Time frame: SAD - Up to Day 57 (end of study visit)
Treatment emergent adverse events
Number of Subjects with Treatment Emergent Adverse Events
Time frame: MAD - Up to Day 85 (end of study visit)
Pharmacokinetic Assessment
Cmax will be assessd
Time frame: Upto Day 57 for SAD , Upto Day 85 for MAD
Pharmacokinetic Assessment
tmax will be assessd
Time frame: Upto Day 57 for SAD , Upto Day 85 for MAD
Pharmacokinetic Assessment
AUC will be assessd
Time frame: Upto Day 57 for SAD , Upto Day 85 for MAD
Pharmacokinetic Assessment
T 1/2 will be assessd
Time frame: Upto Day 57 for SAD , Upto Day 85 for MAD
Pharmacodynamic (PD) effect assessment
LDL-C serum concentration will be assessed.
Time frame: Upto Day 57 for SAD , Upto Day 85 for MAD
Pharmacodynamic (PD) effect assessment
PCSK9 plasma levels concentration will be assessed.
Time frame: Upto Day 57 for SAD , Upto Day 85 for MAD
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