Elevated Low-Density Lipoprotein CholesterolPhase 1NCT05896969
Dose Escalation of SNK-396 in Participants With Elevated Low-Density Lipoprotein Cholesterol
A Phase 1 study testing SNK-396 - SAD cohort and SNK-396 - MAD Cohort in people with Elevated Low-Density Lipoprotein Cholesterol, run by Syneos Health at 3 sites in Australia.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Elevated Low-Density Lipoprotein Cholesterol
- What is being tested?
- SNK-396 - SAD cohort and SNK-396 - MAD Cohort
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 3 sitesAustralia
- Study dates
- 27 Apr 2023to 23 Feb 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
Australia3 sites
Cmax Clinical Research
Adelaide, South Australia, 5000
Nucleus Network Pty Ltd
Herston, Queensland, 4006
Nucleus Network Pty Ltd
Melbourne, Victoria, 3004
About this study
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
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
Read the 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)
- Being tested
- SNK-396 - SAD cohort, SNK-396 - MAD Cohort
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SNK-396 - SAD cohortDrug
A single dose of SNK-396 within the dose range of 25 to 800 mg, or matching placebo.
SNK-396 - MAD CohortDrug
Multiple doses of SNK-396 within the dose range of from 25 to 800 mg, or matching placebo.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Drug: SNK-396 - MAD Cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment emergent adverse events
Number of Subjects with Treatment Emergent Adverse Events
Measured: SAD - Up to Day 57 (end of study visit)
Treatment emergent adverse events
Number of Subjects with Treatment Emergent Adverse Events
Measured: MAD - Up to Day 85 (end of study visit)
Secondary outcomes (6)
Pharmacokinetic Assessment
Cmax will be assessd
Measured: Upto Day 57 for SAD , Upto Day 85 for MAD
Pharmacokinetic Assessment
tmax will be assessd
Measured: Upto Day 57 for SAD , Upto Day 85 for MAD
Pharmacokinetic Assessment
AUC will be assessd
Measured: Upto Day 57 for SAD , Upto Day 85 for MAD
Pharmacokinetic Assessment
T 1/2 will be assessd
Measured: Upto Day 57 for SAD , Upto Day 85 for MAD
Pharmacodynamic (PD) effect assessment
LDL-C serum concentration will be assessed.
Measured: Upto Day 57 for SAD , Upto Day 85 for MAD
Pharmacodynamic (PD) effect assessment
PCSK9 plasma levels concentration will be assessed.
Measured: Upto Day 57 for SAD , Upto Day 85 for MAD
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2023
- Study start27 Apr 2023
- Primary completion23 Feb 2024
- Study completion23 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elevated Low-Density Lipoprotein CholesterolStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Syneos Health
- Sponsor type
- University, hospital or other
- Collaborators
- SynerK Pharmatech (Suzhou) Limited
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05896969
- Sponsor's protocol ID
- SNK-396-101
- Status last verified
- Jun 2024
- First submitted
- 14 Mar 2023
- Last updated
- 21 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05896969
- Acronym / sponsor ID
- SNK-396-101
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Syneos HealthUniversity, hospital or other
- Collaborators
- SynerK Pharmatech (Suzhou) Limited
- Study start
- 27 Apr 2023 (actual)
- Primary completion
- 23 Feb 2024 (actual)
- Study completion
- 23 Feb 2024 (actual)
- First posted
- 9 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| SAD Cohort | Experimental | Drug: SNK-396 - SAD cohortSAD 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. |
| MAD cohort | Experimental | Drug: SNK-396 - MAD CohortMAD 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SNK-396 - SAD cohortA single dose of SNK-396 within the dose range of 25 to 800 mg, or matching placebo. | Drug | SAD Cohort |
| SNK-396 - MAD CohortMultiple doses of SNK-396 within the dose range of from 25 to 800 mg, or matching placebo. | Drug | MAD cohort |
Primary outcome
Treatment emergent adverse events
Time frame: SAD - Up to Day 57 (end of study visit)
Number of Subjects with Treatment Emergent Adverse Events
Treatment emergent adverse events
Time frame: MAD - Up to Day 85 (end of study visit)
Number of Subjects with Treatment Emergent Adverse Events
6 secondary outcomes
Pharmacokinetic Assessment
Time frame: Upto Day 57 for SAD , Upto Day 85 for MAD
Pharmacokinetic Assessment
Time frame: Upto Day 57 for SAD , Upto Day 85 for MAD
Pharmacokinetic Assessment
Time frame: Upto Day 57 for SAD , Upto Day 85 for MAD
Pharmacokinetic Assessment
Time frame: Upto Day 57 for SAD , Upto Day 85 for MAD
Pharmacodynamic (PD) effect assessment
Time frame: Upto Day 57 for SAD , Upto Day 85 for MAD
Pharmacodynamic (PD) effect assessment
Time frame: Upto Day 57 for SAD , Upto Day 85 for MAD
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SNK-396 - SAD cohort and SNK-396 - MAD Cohort in people with Elevated Low-Density Lipoprotein Cholesterol, run by Syneos Health at 3 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment emergent adverse events (time frame: SAD - Up to Day 57 (end of study visit)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2024.