Elevated Low-Density Lipoprotein Cholesterol
Conditions
Brief summary
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
Detailed description
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)
Interventions
DRUGSNK-396 - SAD cohort
A single dose of SNK-396 within the dose range of 25 to 800 mg, or matching placebo.
DRUGSNK-396 - MAD Cohort
Multiple doses of SNK-396 within the dose range of from 25 to 800 mg, or matching placebo.
Sponsors
SynerK Pharmatech (Suzhou) Limited
Syneos Health
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
This is a Phase 1, multi-center, randomized, double-blind, 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 two parts will be completed sequentially. The MAD part may be initiated when safety, tolerability, and PK data are known and deemed acceptable for single doses of at least the 5 planned dose levels of the SAD cohorts.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
- 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment emergent adverse events | SAD - Up to Day 57 (end of study visit) | Number of Subjects with Treatment Emergent Adverse Events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic Assessment | Upto Day 57 for SAD , Upto Day 85 for MAD | Cmax will be assessd |
| Pharmacodynamic (PD) effect assessment | Upto Day 57 for SAD , Upto Day 85 for MAD | LDL-C serum concentration will be assessed. |
Countries
Australia
Outcome results
None listed