Dose Escalation of SNK-396 in Participants With Elevated Low-Density Lipoprotein Cholesterol
About the study
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
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Inclusion Criteria -
- Male or female, ≥18 and ≤65 years of age, with BMI ≥18.5 and ≤35.0 kg/m2.
- Participants must be either non smoking (no use of tobacco or nicotine products within 3 months prior to screening) or social smoker as defined by smoking no more than 5 cigarettes (or nicotine equivalent) a week and no smoking during screening period or on study.
- Participants must be with elevated LDL-C defined as serum LDL levels between 2.6 - 4.9 mmol/L (inclusive) at screening.
- Healthy (except for the LDL-C status) participants.
- Participants must have fasting triglyceride level <4.52 mmol/L (<400mg/dL) at screening.
- Sexually active females of childbearing potential and non-sterile males must be willing to use an acceptable contraceptive method throughout the study as detailed in section 8.1.
- Able to understand the study procedures and provide signed informed consent to participate in the study.
EXCLUSION CRITERIA
Exclusion Criteria -
- Any clinically significant abnormal finding at physical examination in the opinion of the investigator.
- Subjects with a history or presence of cardiovascular disease (including cerebrovascular accident (stroke or TIA) or disease, uncontrolled hypertension, familial hypercholesterolaemia, obstructive sleep apnoea, and peripheral artery), a diagnosis of diabetes mellitus given potential for hyperglycaemia defined as HbA1c greater or equal to 6.5%, or a non-alcoholic fatty liver disease.
- Received Leqvio (inclisiran) treatment in less than 6 months ago.
- Any reason which, in the opinion of the Investigator, would prevent the participant from participating in the study.
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study Details
Contition
Elevated Low-Density Lipoprotein Cholesterol
Age (in years)
18 - 65
Phase
PHASE1
Participants Needed
41
Est. Completion Date
Feb 23, 2024
Treatment Type
INTERVENTIONAL
Sponsor
Syneos Health
ClinicalTrials.gov NCT Identifier
NCT05896969
Study Number
SNK-396-101
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