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

Launched by SUZHOU SANEGENE BIO INC. · Jan 25, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called SGB-3403, which is being tested for its safety and effectiveness in lowering "bad" cholesterol (LDL-C) levels. The study will involve healthy volunteers and people with elevated cholesterol. Participants will receive either the treatment or a placebo (a substance with no active effects) to see how well it works and how the body reacts to it.

To be eligible for this study, participants should be between 18 and 65 years old and have a specific range of body weight and cholesterol levels. Healthy volunteers should have normal health checks, while those with high cholesterol should have levels that fall within a certain range. Participants can expect to undergo various health assessments and follow a schedule of visits, all while providing informed consent to take part in the trial. It's important to note that this study is not yet recruiting participants, so there will be some time before it begins.

Gender

ALL

Eligibility criteria

• Inclusion Criteria in SAD:
• • 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.
• Exclusion Criteria in SAD:
• • 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.
• Inclusion Criteria in MAD:
• • 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.