Phase 1, Single Multiple Dose Escalation Study in a Randomized, Double-blind, Placebo Controlled Design to Investigate Safety, Tolerability, PK and PD of SC Administered SNK-396 in Subjects With Elevated Low-Density Lipoprotein Cholesterol
Overview
- Phase
- Phase 1
- Intervention
- SNK-396 - SAD cohort
- Conditions
- Elevated Low-Density Lipoprotein Cholesterol
- Sponsor
- Syneos Health
- Enrollment
- 41
- Locations
- 2
- Primary Endpoint
- Treatment emergent adverse events
- Status
- Completed
- Last Updated
- last year
Overview
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)
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
SAD Cohort
SAD Cohort 1 - 8 : Subjects in each cohort will be randomised will receive a single SC dose of SNK-396 within the dose range of 25 to 800 mg, or matching placebo.
Intervention: SNK-396 - SAD cohort
MAD cohort
MAD Cohort 1 - 8 : Subjects in each cohort will be randomized will receive the active SNK-396 with dose range of SNK-396 anticipated to be from 25 to 800 mg or matching placebo
Intervention: SNK-396 - MAD Cohort
Outcomes
Primary Outcomes
Treatment emergent adverse events
Time Frame: MAD - Up to Day 85 (end of study visit)
Number of Subjects with Treatment Emergent Adverse Events
Secondary Outcomes
- Pharmacodynamic (PD) effect assessment(Upto Day 57 for SAD , Upto Day 85 for MAD)
- Pharmacokinetic Assessment(Upto Day 57 for SAD , Upto Day 85 for MAD)