A Study to Evaluate SGB-3403 in Healthy Volunteers
- Conditions
- HypercholesterolemiaCardiovascular - Other cardiovascular diseases
- Registration Number
- ACTRN12623000439640
- Lead Sponsor
- Sanegene Bio Australia Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Stopped early
- Sex
- All
- Target Recruitment
- 13
1.Male and female subjects aged 18 to 55 years are included.
2. Body mass index between 18 and 32 kg/m2, inclusive.
3.COVID-19 test negative before being admitted to the clinical study site.
4.Subjects and partners must agree to use 2 methods of highly effective contraception from signing informed consent until completion of the follow-up visit or postdose 90 days (whichever is longer).
1.The positive result of hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab), human immunodeficiency virus (HIV) antibody, or syphilis at screening.
2.Alanine aminotransferase (ALT), total bilirubin (TBIL), aspartate aminotransferase (AST), alkaline phosphatase (ALP), or gamma-glutamyl transferase (GGT) greater than or equal to 2 × ULN; or, if AST, ALP, or GGT greater than or equal to 1 × ULN, but less than or equal to 2 × ULN and considered clinically relevant by the Investigator.
3.History of multiple drug allergies or allergic reactions to an oligonucleotide or N acetylgalactosamine (GalNAc).
4.History of intolerance to subcutaneous (SC) injection or relevant abdominal scarring (surgical, burns, etc.)
5.Received an investigational agent (including PCSK9 inhibitors) within 30 days or 5 half-lives (whichever is longer) before the first dose of the study drug or are in another clinical study.
6.History or clinical evidence of drug abuse within the 12 months before screening or positive screen for drugs of abuse.
7.Alcohol consumption greater than 14 standard drinks per week within one month before screening or positive screen for an alcohol breath test (1 standard drink equal to 10 grams of alcohol).
8.Regular tobacco use equal to 5 cigarettes per day within 6 months before screening.
9.Donate more than 500 mL of blood within 90 days before the first dose of the study drug.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method