A Study to Evaluate SGB-3403 in Healthy Volunteers and Subjects With Elevated Low-Density Lipoprotein Cholesterol (LDL-C)

NCT ID: NCT06239714

Last Updated: 2024-02-02

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-18
• Study Completion Date: 2025-05-30

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

SGB-3403(SAD)

Group Type: EXPERIMENTAL

SGB-3403

Intervention Type: DRUG

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.

placebo(SAD)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Normal saline 0.9%

SGB-3403(Non-Statin MAD)

Group Type: EXPERIMENTAL

SGB-3403

Intervention Type: DRUG

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.

placebo(Non-Statin MAD)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Normal saline 0.9%

SGB-3403 and atorvastatin(statin MAD)

Group Type: EXPERIMENTAL

SGB-3403

Intervention Type: DRUG

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.

Atorvastatin

Intervention Type: OTHER

The dosage of atorvastatin was determined by the investigator

placebo and atorvastatin(statin MAD)

Group Type: PLACEBO_COMPARATOR

Atorvastatin

Intervention Type: OTHER

The dosage of atorvastatin was determined by the investigator

Placebo

Intervention Type: OTHER

Normal saline 0.9%

Interventions

SGB-3403

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.

Intervention Type: DRUG

Atorvastatin

The dosage of atorvastatin was determined by the investigator

Intervention Type: OTHER

Placebo

Normal saline 0.9%

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.)
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Suzhou Sanegene Bio Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Xiaolin He, Master

Role: CONTACT

xiaolin_he@sanegenebio.com

+086 18132286536

Xuekun Yao, Master

Role: CONTACT

xuekun_yao@sanegenebio.com

+086 15830172897

Other Identifiers

SGB-3403-001

Identifier Type: -

Identifier Source: org_study_id