HyperlipidemiasPhase 1NCT06239714
A Study to Evaluate SGB-3403 in Healthy Volunteers and Subjects With Elevated Low-Density Lipoprotein Cholesterol (LDL-C)
A Phase 1 study testing SGB-3403 and Atorvastatin in people with Hyperlipidemias, run by Suzhou Sanegene Bio Inc..
Trial summary
This study is a randomized, double-blind, placebo-controlled, single ascending dose (SAD) and multiple ascending doses (MAD) of SGB-3403 when single administered subcutaneously to healthy volunteers and multiple administered subcutaneously to subjects with elevated LDL-C to evaluate the safety, tolerance, PK, and PD. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperlipidemias
- What is being tested?
- SGB-3403 and Atorvastatin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- 18 Feb 2024to 30 May 2025
- 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 and female subjects aged 18 to 55 years are included.
- Body mass index between 19 and 32 kg/m2, inclusive.
- Physical examination, vital signs, 12-lead electrocardiogram, and laboratory tests will be normal or slightly abnormal but not clinically significant according to the Investigator's judgment.
- Willing to comply with the protocol required visit schedule and visit requirements and provide written informed consent.
- Male and female subjects aged 18 to 65 years are included.
- Body mass index between 19 and 35 kg/m2, inclusive.
- Serum LDL-C ≥ 2.6mmol/L (≤ 100 mg/dL) and ≤ 4.9 mmol/L (≤ 190 mg/dL) at screening.
- Fasting triglyceride < 4.52 mmol/L (< 400 mg/dL) at screening.
Who cannot join
- An underlying known disease or surgical or medical condition that, in the opinion of the Investigator, might interfere with the interpretation of the clinical study results.
- The positive result of hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab), human immunodeficiency virus (HIV) antibody, or syphilis at screening.
- Alanine aminotransferase (ALT), total bilirubin (TBIL), aspartate aminotransferase (AST), alkaline phosphatase (ALP), or gamma-glutamyl transferase (GGT) > 1.5 × ULN (upper limit of normal).
- Serum creatinine exceeds the upper limit of normal at screening.
- History of multiple drug allergies or allergic reactions to an oligonucleotide or N acetylgalactosamine (GalNAc).
- History of intolerance to subcutaneous (SC) injection or relevant abdominal scarring (surgical, burns, etc.)
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- Received an investigational agent within 28 days or 5 half-lives (whichever is longer) before the first dose of the study drug or are in another clinical study, received INCLISIRAN within 1 year.
- Use any Chinese herbs, vitamins, or supplements known to affect lipid metabolism (e.g., fish oil > 1000 mg/ day, medicines, or health products containing red yeast rice) within 28 days before receiving the test drug.
- Any conditions which, in the opinion of the Investigator, would make the subject unsuitable for enrollment or could interfere with the subject's participation in or completion of the study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, SAD and MAD Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered SGB-3403 in Healthy Volunteers and Subjects With Elevated LDL-C
This study is a randomized, double-blind, placebo-controlled, single ascending dose (SAD) and multiple ascending doses (MAD) of SGB-3403 when single administered subcutaneously to healthy volunteers and multiple administered subcutaneously to subjects with elevated LDL-C to evaluate the safety, tolerance, PK, and PD.
Read the detailed description
This study is a randomized, double-blind, placebo-controlled, single ascending dose (SAD) and multiple ascending doses (MAD) of SGB-3403 when single administered subcutaneously to healthy volunteers and multiple administered subcutaneously to subjects with elevated LDL-C. The study will be performed in 2 phases: SAD and MAD.
- Conditions
- Hyperlipidemias
- Being tested
- SGB-3403, Atorvastatin, Placebo
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SGB-3403Drug
SGB-3403 is a synthetic, chemically modified small interfering ribonucleic acid (siRNA) targeting proprotein convertase subtilisin kexin type 9 (PCSK9) messenger ribonucleic acid (mRNA) with a covalently attached triantennary N-acetylgalactosamine (GalNAc) ligand.
AtorvastatinOther
The dosage of atorvastatin was determined by the investigator
PlaceboOther
Normal saline 0.9%
| Study group | Role | What they receive |
|---|---|---|
| SGB-3403(SAD) | Experimental | Not described Receives: Drug: SGB-3403 |
| placebo(SAD) | Placebo comparator | Not described Receives: Other: Placebo |
| SGB-3403(Non-Statin MAD) | Experimental | Not described Receives: Drug: SGB-3403 |
| placebo(Non-Statin MAD) | Placebo comparator | Not described Receives: Other: Placebo |
| SGB-3403 and atorvastatin(statin MAD) | Experimental | Not described Receives: Drug: SGB-3403; Other: Atorvastatin |
| placebo and atorvastatin(statin MAD) | Placebo comparator | Not described Receives: Other: Atorvastatin; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events (AEs)
To evaluate the safety and tolerability of SGB-3403 when administered subcutaneously as a single dose to healthy volunteers
Measured: 57 days
Number of participants with abnormal laboratory tests results
To evaluate the safety and tolerability of SGB-3403 when administered subcutaneously as a single dose to healthy volunteers
Measured: 57 days
Number of participants with adverse events (AEs)
To evaluate the safety and tolerability of SGB-3403 when administered subcutaneously in multiple-dose to subjects with elevated LDL-C
Measured: 169 days
Number of participants with abnormal laboratory tests results
To evaluate the safety and tolerability of SGB-3403 when administered subcutaneously in multiple-dose to subjects with elevated LDL-C
Measured: 169 days
Secondary outcomes (6)
Maximum observed plasma concentration (Cmax)
To characterize the pharmacokinetics of SGB-3403 in healthy volunteers and subjects with elevated LDL-C
Measured: 48 hours
Area under the concentration-time curve (AUC)
To characterize the pharmacokinetics of SGB-3403 in healthy volunteers and subjects with elevated LDL-C
Measured: 48 hours
LDL-C change from baseline
To evaluate the pharmacodynamic effect of SGB-3403 on serum levels of LDL-C in healthy volunteers
Measured: 180 days
LDL-C change from baseline
To evaluate the pharmacodynamic effect of SGB-3403 on serum levels of LDL-C in subjects with elevated LDL-C
Measured: 265 days
PCSK9 change from baseline
To evaluate the pharmacodynamic effect of SGB-3403 on plasma levels of proprotein convertase subtilisin/kexin type 9 in healthy volunteers
Measured: 180 days
PCSK9 change from baseline
To evaluate the pharmacodynamic effect of SGB-3403 on plasma levels of proprotein convertase subtilisin/kexin type 9 in subjects with elevated LDL-C
Measured: 265 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2024
- Study start18 Feb 2024 (estimated)
- Primary completion18 Feb 2025 (estimated)
- Study completion30 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperlipidemiasStudies 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suzhou Sanegene Bio Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06239714
- Sponsor's protocol ID
- SGB-3403-001
- Status last verified
- Jan 2024
- First submitted
- 8 Jan 2024
- Last updated
- 2 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Placebo-Controlled, SAD and MAD Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered SGB-3403 in Healthy Volunteers and Subjects With Elevated LDL-C
- ClinicalTrials.gov ID
- NCT06239714
- Acronym / sponsor ID
- SGB-3403-001
- Conditions
- Hyperlipidemias
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Suzhou Sanegene Bio Inc.Industry (pharma, biotech, devices)
- Study start
- 18 Feb 2024 (estimated)
- Primary completion
- 18 Feb 2025 (estimated)
- Study completion
- 30 May 2025 (estimated)
- First posted
- 2 Feb 2024 (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 study is a randomized, double-blind, placebo-controlled, single ascending dose (SAD) and multiple ascending doses (MAD) of SGB-3403 when single administered subcutaneously to healthy volunteers and multiple administered subcutaneously to subjects with elevated LDL-C to evaluate the safety, tolerance, PK, and PD.
Detailed description
This study is a randomized, double-blind, placebo-controlled, single ascending dose (SAD) and multiple ascending doses (MAD) of SGB-3403 when single administered subcutaneously to healthy volunteers and multiple administered subcutaneously to subjects with elevated LDL-C. The study will be performed in 2 phases: SAD and MAD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| SGB-3403(SAD) | Experimental | Drug: SGB-3403 |
| placebo(SAD) | Placebo comparator | Other: Placebo |
| SGB-3403(Non-Statin MAD) | Experimental | Drug: SGB-3403 |
| placebo(Non-Statin MAD) | Placebo comparator | Other: Placebo |
| SGB-3403 and atorvastatin(statin MAD) | Experimental | Drug: SGB-3403, Other: Atorvastatin |
| placebo and atorvastatin(statin MAD) | Placebo comparator | Other: Atorvastatin, Other: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male and female subjects aged 18 to 55 years are included.
- Body mass index between 19 and 32 kg/m2, inclusive.
- Physical examination, vital signs, 12-lead electrocardiogram, and laboratory tests will be normal or slightly abnormal but not clinically significant according to the Investigator's judgment.
- Willing to comply with the protocol required visit schedule and visit requirements and provide written informed consent.
- Male and female subjects aged 18 to 65 years are included.
Key exclusion criteria (9 listed)
- An underlying known disease or surgical or medical condition that, in the opinion of the Investigator, might interfere with the interpretation of the clinical study results.
- The positive result of hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab), human immunodeficiency virus (HIV) antibody, or syphilis at screening.
- Alanine aminotransferase (ALT), total bilirubin (TBIL), aspartate aminotransferase (AST), alkaline phosphatase (ALP), or gamma-glutamyl transferase (GGT) > 1.5 × ULN (upper limit of normal).
- Serum creatinine exceeds the upper limit of normal at screening.
- History of multiple drug allergies or allergic reactions to an oligonucleotide or N acetylgalactosamine (GalNAc).
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 |
|---|---|---|
| SGB-3403SGB-3403 is a synthetic, chemically modified small interfering ribonucleic acid (siRNA) targeting proprotein convertase subtilisin kexin type 9 (PCSK9) messenger ribonucleic acid (mRNA) with a covalently attached triantennary N-acetylgalactosamine (GalNAc) ligand. | Drug | SGB-3403 and atorvastatin(statin MAD), SGB-3403(Non-Statin MAD), SGB-3403(SAD) |
| AtorvastatinThe dosage of atorvastatin was determined by the investigator | Other | SGB-3403 and atorvastatin(statin MAD), placebo and atorvastatin(statin MAD) |
| PlaceboNormal saline 0.9% | Other | placebo and atorvastatin(statin MAD), placebo(Non-Statin MAD), placebo(SAD) |
Primary outcome
Number of participants with adverse events (AEs)
Time frame: 57 days
To evaluate the safety and tolerability of SGB-3403 when administered subcutaneously as a single dose to healthy volunteers
Number of participants with abnormal laboratory tests results
Time frame: 57 days
To evaluate the safety and tolerability of SGB-3403 when administered subcutaneously as a single dose to healthy volunteers
Number of participants with adverse events (AEs)
Time frame: 169 days
To evaluate the safety and tolerability of SGB-3403 when administered subcutaneously in multiple-dose to subjects with elevated LDL-C
Number of participants with abnormal laboratory tests results
Time frame: 169 days
To evaluate the safety and tolerability of SGB-3403 when administered subcutaneously in multiple-dose to subjects with elevated LDL-C
6 secondary outcomes
Maximum observed plasma concentration (Cmax)
Time frame: 48 hours
Area under the concentration-time curve (AUC)
Time frame: 48 hours
LDL-C change from baseline
Time frame: 180 days
LDL-C change from baseline
Time frame: 265 days
PCSK9 change from baseline
Time frame: 180 days
PCSK9 change from baseline
Time frame: 265 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SGB-3403 and Atorvastatin in people with Hyperlipidemias, run by Suzhou Sanegene Bio Inc..
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 8 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 2 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaolin He, Master (+086 18132286536, xiaolin_he@sanegenebio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events (AEs) (time frame: 57 days). The study lists 4 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 2 Feb 2024.