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

• Sponsor: Syneos Health (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05896969
• Collaborator: SynerK Pharmatech (Suzhou) Limited (Other)
• Enrollment: 128
• Locations: 3
• Arms: 2
• Anticipated Duration (Months): 18.2
• Patients Per Site: 42.7
• Patients Per Site Per Month: 2.3

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Elevated Low-Density Lipoprotein Cholesterol	Drug: SNK-396 - SAD cohort; Drug: SNK-396 - MAD Cohort	Phase 1

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 128 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• 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.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.
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: Apr 27, 2023
• Anticipated Primary Completion Date: Oct 31, 2024
• Anticipated Study Completion Date: Oct 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: SNK-396 - SAD cohort; A single dose of SNK-396 within the dose range of 25 to 800 mg, or matching placebo.
Experimental: 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	Drug: SNK-396 - MAD Cohort; Multiple doses of SNK-396 within the dose range of from 25 to 800 mg, or matching placebo.

Outcome Measures

Primary Outcome Measures

1. Treatment emergent adverse events [SAD - Up to Day 57 (end of study visit)]

   Number of Subjects with Treatment Emergent Adverse Events

2. Treatment emergent adverse events [MAD - Up to Day 85 (end of study visit)]

   Number of Subjects with Treatment Emergent Adverse Events

Secondary Outcome Measures

1. Pharmacokinetic Assessment [Upto Day 57 for SAD , Upto Day 85 for MAD]

   Cmax will be assessd

2. Pharmacokinetic Assessment [Upto Day 57 for SAD , Upto Day 85 for MAD]

   tmax will be assessd

3. Pharmacokinetic Assessment [Upto Day 57 for SAD , Upto Day 85 for MAD]

   AUC will be assessd

4. Pharmacokinetic Assessment [Upto Day 57 for SAD , Upto Day 85 for MAD]

   T 1/2 will be assessd

5. Pharmacodynamic (PD) effect assessment [Upto Day 57 for SAD , Upto Day 85 for MAD]

   LDL-C serum concentration will be assessed.

6. Pharmacodynamic (PD) effect assessment [Upto Day 57 for SAD , Upto Day 85 for MAD]

   PCSK9 plasma levels concentration will be assessed.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nucleus Network Pty Ltd	Herston	Queensland	Australia	4006
2	Cmax Clinical Research	Adelaide	South Australia	Australia	5000
3	Nucleus Network Pty Ltd	Melbourne	Victoria	Australia	3004

Sponsors and Collaborators

• Syneos Health
• SynerK Pharmatech (Suzhou) Limited

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Syneos Health
• ClinicalTrials.gov Identifier: NCT05896969
• Other Study ID Numbers: SNK-396-101
• First Posted: Jun 9, 2023
• Last Update Posted: Jun 9, 2023
• Last Verified: Apr 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jun 9, 2023