A Study to Evaluate SGB-3403 in Healthy Volunteers and Subjects With Elevated Low-Density Lipopro… (NCT06239714) | Clinical Trial Compass
UnknownPhase 1
A Study to Evaluate SGB-3403 in Healthy Volunteers and Subjects With Elevated Low-Density Lipoprotein Cholesterol (LDL-C)
64 participantsStarted 2024-02-18
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 INCLI…
What they're measuring
1
Number of participants with adverse events (AEs)
Timeframe: 57 days
2
Number of participants with abnormal laboratory tests results
Timeframe: 57 days
3
Number of participants with adverse events (AEs)
Timeframe: 169 days
4
Number of participants with abnormal laboratory tests results