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

NCT ID: NCT05896969

Last Updated: 2024-06-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-27
• Study Completion Date: 2024-02-23

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)

Conditions

Elevated Low-Density Lipoprotein Cholesterol

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

SNK-396 - SAD cohort

Intervention Type: DRUG

A single dose of SNK-396 within the dose range of 25 to 800 mg, or matching placebo.

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

Group Type: EXPERIMENTAL

SNK-396 - MAD Cohort

Intervention Type: DRUG

Multiple doses of SNK-396 within the dose range of from 25 to 800 mg, or matching placebo.

Interventions

SNK-396 - SAD cohort

A single dose of SNK-396 within the dose range of 25 to 800 mg, or matching placebo.

Intervention Type: DRUG

SNK-396 - MAD Cohort

Multiple doses of SNK-396 within the dose range of from 25 to 800 mg, or matching placebo.

Intervention Type: DRUG

Eligibility 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

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

SynerK Pharmatech (Suzhou) Limited

UNKNOWN

Sponsor Role: collaborator

Syneos Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Nucleus Network Pty Ltd

Herston, Queensland, Australia

Cmax Clinical Research

Adelaide, South Australia, Australia

Nucleus Network Pty Ltd

Melbourne, Victoria, Australia

Countries

Australia

Other Identifiers

SNK-396-101

Identifier Type: -

Identifier Source: org_study_id