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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05896969




Registration number
NCT05896969
Ethics application status
Date submitted
14/03/2023
Date registered
9/06/2023
Date last updated
21/08/2023

Titles & IDs
Public title
Dose Escalation of SNK-396 in Participants With Elevated Low-Density Lipoprotein Cholesterol
Scientific 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
Secondary ID [1] 0 0
SNK-396-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Elevated Low-Density Lipoprotein Cholesterol 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - SNK-396 - SAD cohort
Treatment: Drugs - SNK-396 - MAD Cohort

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.

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


Treatment: Drugs: SNK-396 - SAD cohort
A single dose of SNK-396 within the dose range of 25 to 800 mg, or matching placebo.

Treatment: Drugs: SNK-396 - MAD Cohort
Multiple doses of SNK-396 within the dose range of from 25 to 800 mg, or matching placebo.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Treatment emergent adverse events
Timepoint [1] 0 0
SAD - Up to Day 57 (end of study visit)
Primary outcome [2] 0 0
Treatment emergent adverse events
Timepoint [2] 0 0
MAD - Up to Day 85 (end of study visit)
Secondary outcome [1] 0 0
Pharmacokinetic Assessment
Timepoint [1] 0 0
Upto Day 57 for SAD , Upto Day 85 for MAD
Secondary outcome [2] 0 0
Pharmacokinetic Assessment
Timepoint [2] 0 0
Upto Day 57 for SAD , Upto Day 85 for MAD
Secondary outcome [3] 0 0
Pharmacokinetic Assessment
Timepoint [3] 0 0
Upto Day 57 for SAD , Upto Day 85 for MAD
Secondary outcome [4] 0 0
Pharmacokinetic Assessment
Timepoint [4] 0 0
Upto Day 57 for SAD , Upto Day 85 for MAD
Secondary outcome [5] 0 0
Pharmacodynamic (PD) effect assessment
Timepoint [5] 0 0
Upto Day 57 for SAD , Upto Day 85 for MAD
Secondary outcome [6] 0 0
Pharmacodynamic (PD) effect assessment
Timepoint [6] 0 0
Upto Day 57 for SAD , Upto Day 85 for MAD

Eligibility
Key inclusion 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.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/04/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/10/2024
Actual
Sample size
Target
128
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC
Recruitment hospital [1] 0 0
Nucleus Network Pty Ltd - Herston
Recruitment hospital [2] 0 0
Cmax Clinical Research - Adelaide
Recruitment hospital [3] 0 0
Nucleus Network Pty Ltd - Melbourne
Recruitment postcode(s) [1] 0 0
4006 - Herston
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment postcode(s) [3] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Syneos Health
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
SynerK Pharmatech (Suzhou) Limited
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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
Trial website
https://clinicaltrials.gov/ct2/show/NCT05896969
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Reza Pishva
Address 0 0
Country 0 0
Phone 0 0
+61286669340
Fax 0 0
Email 0 0
reza.pishva@syneoshealth.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05896969