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

NCT06239714 | Unknown Phase 1

• 1 other identifier: SGB-3403-001
• Study Type: interventional
• Target: 64
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hyperlipidemias

Outcome Measures

Primary Outcomes (4)

• 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

  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

  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

  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

  169 days

Secondary Outcomes (6)

• Maximum observed plasma concentration (Cmax)

  48 hours

• Area under the concentration-time curve (AUC)

  48 hours

• LDL-C change from baseline

  180 days

• LDL-C change from baseline

  265 days

• PCSK9 change from baseline

  180 days

Study Arms (6)

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

Interventions

SGB-3403 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.

SGB-3403 and atorvastatin(statin MAD); SGB-3403(Non-Statin MAD); SGB-3403(SAD)

Atorvastatin OTHER

The dosage of atorvastatin was determined by the investigator

SGB-3403 and atorvastatin(statin MAD); placebo and atorvastatin(statin MAD)

Placebo OTHER

Normal saline 0.9%

placebo and atorvastatin(statin MAD); placebo(Non-Statin MAD); placebo(SAD)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Suzhou Sanegene Bio Inc.: lead

MeSH Terms

Conditions

Hyperlipidemias

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Central Study Contacts

Xiaolin He, Master

CONTACT

+086 18132286536; xiaolin_he@sanegenebio.com

Xuekun Yao, Master

CONTACT

+086 15830172897; xuekun_yao@sanegenebio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2024
• First Posted: February 2, 2024
• Study Start: February 18, 2024
• Primary Completion: February 18, 2025
• Study Completion: May 30, 2025
• Last Updated: February 2, 2024

Record last verified: 2024-01