Dose Escalation of SNK-396 in Participants With Elevated Low-Density Lipoprotein Cholesterol

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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
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria -


  1. Male or female, ≥18 and ≤65 years of age, with BMI ≥18.5 and ≤35.0 kg/m2.
  2. 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.
  3. Participants must be with elevated LDL-C defined as serum LDL levels between 2.6 - 4.9 mmol/L (inclusive) at screening.
  4. Healthy (except for the LDL-C status) participants.
  5. Participants must have fasting triglyceride level <4.52 mmol/L (<400mg/dL) at screening.
  6. 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.
  7. Able to understand the study procedures and provide signed informed consent to participate in the study.

EXCLUSION CRITERIA

Exclusion Criteria -


  1. Any clinically significant abnormal finding at physical examination in the opinion of the investigator.
  2. 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.
  3. Received Leqvio (inclisiran) treatment in less than 6 months ago.
  4. Any reason which, in the opinion of the Investigator, would prevent the participant from participating in the study.

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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.
Phone iconCall +61286669340Email iconEmail Study Center

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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