NCT05896969

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Syneos Health · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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)

Conditions

• Elevated Low-Density Lipoprotein Cholesterol

Interventions

Type	Name	Description
DRUG	SNK-396 - SAD cohort	A single dose of SNK-396 within the dose range of 25 to 800 mg, or matching placebo.
DRUG	SNK-396 - MAD Cohort	Multiple doses of SNK-396 within the dose range of from 25 to 800 mg, or matching placebo.

Timeline

• Start date: 2023-04-27
• Primary completion: 2024-02-23
• Completion: 2024-02-23
• First posted: 2023-06-09
• Last updated: 2024-06-21

Locations

3 sites across 1 country: Australia