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

Phase 1

Completed

• Conditions: Elevated Low-Density Lipoprotein Cholesterol
• Interventions: Drug: SNK-396 - MAD Cohort; Drug: SNK-396 - SAD cohort

• Registration Number: NCT05896969
• Lead Sponsor: Syneos Health

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)

Study Timeline

• Study First Submitted: 2023-03-14
• Study Start: 2023-04-27
• Study First Submitted QC: 2023-06-06
• Study First Posted: 2023-06-09
• Primary Completion: 2024-02-23
• Study Completion: 2024-02-23
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-19
• Last Update Posted: 2024-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
MAD cohort	SNK-396 - 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
SAD Cohort	SNK-396 - 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.

Primary Outcome Measures

Name	Time	Method
Treatment emergent adverse events	MAD - Up to Day 85 (end of study visit)	Number of Subjects with Treatment Emergent Adverse Events

Secondary Outcome Measures

Name	Time	Method
Pharmacodynamic (PD) effect assessment	Upto Day 57 for SAD , Upto Day 85 for MAD	PCSK9 plasma levels concentration will be assessed.
Pharmacokinetic Assessment	Upto Day 57 for SAD , Upto Day 85 for MAD	T 1/2 will be assessd

Trial Locations

Locations (2)

Cmax Clinical Research; 🇦🇺 Adelaide, South Australia, Australia

Nucleus Network Pty Ltd; 🇦🇺 Melbourne, Victoria, Australia