Dose Escalation of SNK-396 in Participants With Elevated... | NCT05896969

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

NCT05896969

Sponsor

Syneos Health

Status

Completed

Last Update Posted

Jun 21, 2024Actual

Enrollment

41Actual

Phase

Phase 1

Conditions

Elevated Low-Density Lipoprotein Cholesterol

Interventions

SNK-396 - SAD cohort
SNK-396 - MAD Cohort

Countries

Australia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 27, 2023Actual

Primary Completion Date

Feb 23, 2024Actual

Completion Date

Feb 23, 2024Actual

First Submitted Date

Mar 14, 2023

First Submission Date that Met QC Criteria

Jun 6, 2023

First Posted Date

Jun 9, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 19, 2024

Last Update Posted Date

Jun 21, 2024Actual

Name	Class
SynerK Pharmatech (Suzhou) Limited	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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)

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

41Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SAD Cohort	Experimental	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.	Drug: SNK-396 - SAD cohort
MAD cohort	Experimental	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	Drug: SNK-396 - MAD Cohort

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SNK-396 - SAD cohort	Drug	A single dose of SNK-396 within the dose range of 25 to 800 mg, or matching placebo.	SAD Cohort

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Treatment emergent adverse events	Number of Subjects with Treatment Emergent Adverse Events	SAD - Up to Day 57 (end of study visit)
Treatment emergent adverse events	Number of Subjects with Treatment Emergent Adverse Events	MAD - Up to Day 85 (end of study visit)

Secondary Outcomes

Measure	Description	Time Frame
Pharmacokinetic Assessment	Cmax will be assessd	Upto Day 57 for SAD , Upto Day 85 for MAD
Pharmacokinetic Assessment	tmax will be assessd

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria -

Male or female, ≥18 and ≤65 years of age, with BMI ≥18.5 and ≤35.0 kg/m2.
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.
Participants must be with elevated LDL-C defined as serum LDL levels between 2.6 - 4.9 mmol/L (inclusive) at screening.
Healthy (except for the LDL-C status) participants.
Participants must have fasting triglyceride level <4.52 mmol/L (<400mg/dL) at screening.
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.
Able to understand the study procedures and provide signed informed consent to participate in the study.

Exclusion Criteria -

Any clinically significant abnormal finding at physical examination in the opinion of the investigator.
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.
Received Leqvio (inclisiran) treatment in less than 6 months ago.
Any reason which, in the opinion of the Investigator, would prevent the participant from participating in the study.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Nucleus Network Pty Ltd		Herston	Queensland	4006	Australia
Cmax Clinical Research

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.