A Single-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of FXR0906 in Healthy Adult Participants With or Without Elevated Triglycerides
This is a phase 1, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics effects of a single dose of FXR0906 injection or placebo in Chinese healthy adult volunteers with or without TG increase.
This phase 1 study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single dose of FXR0906 injection in healthy adults with or without TG increase. Eligible enrolled participants will be randomized to 3 groups receiving FXR0906 (dose 1 or dose 2) or placebo on Day 1 and will be followed up for about 26 weeks
Inclusion criteria： 1\. Males or females aged ≥18 and ≤55 years at the time of screening; 2. Body mass index (BMI) ≥18.0 and ≤35.0 kg/m² at the time of screening, with female participants weighing \>45 kg and male participants weighing \>50 kg; 3. Fasting serum triglyceride (TG) level TG \> 80 mg/dL (0.90 mmol/L) during screening; 4. Fasting LDL-C level ≥ 70 mg/dL (1.81 mmol/L) during screening;
Exclusion criteria: 1. History or presence of clinically significant diseases/abnormality, or with clinically significant symptoms/signs, or self-reported diseases, unsuitable for enrollement in the judgement of the investigator. 2\. Fasting blood glucose ≥7.0 mmol/L or HbA1c ≥6.5% during screening. 3. Use of any lipid-lowering treatment (e.g., drugs lowering LDL-C or TG), including but not limited to statins, ezetimibe, fibrates, omega-3 fatty acids, nutritional supplements, or other treatment regimens altering serum lipids within 30 days prior to screening, or use of any ASO or siRNA therapies lowering serum lipids within 12 months prior to screening.. 4\. Use of investigational drugs or instruments within 3 months prior to screening , or plans to participate in other clinical trials during this study. 5. Clinical laboratory parameters during screening meeting any of the following criteria: 1. ALT and/or AST \>1.5 × ULN 2. ALT and/or AST \> ULN and ≤1.5 × ULN, deemed clinically significant and unsuitable for participation in the clinical trial by the investigator 3. INR \> ULN, deemed clinically significant and unsuitable for participation in the clinical trial by the investigator 4. Estimated glomerular filtration rate (eGFR) \<90 mL/min/1.73 m2 (using MDRD formula) 5. Other examination abnormalities deemed clinically significant and unsuitable for participation in the clinical trial by the investigator
[{"measure":"safety","timeFrame":"through study completion, an average of 26 weeks"}]