[Translation] A single-center, randomized, double-blind, placebo-controlled study evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of FXR0906 in healthy adult participants with or without elevated triglycerides.
主要目的:评估伴或不伴甘油三脂升高中国健康成人参与者单次皮下注射FXR0906后的安全性和耐受性。
次要目的:评估FXR0906及其代谢物AS3’N-1在成人参与者中血浆PK特征;评估FXR0906对成人参与者血清APOC3水平的影响;评估FXR0906对成人参与者血清TG水平的影响。
探索性目的:评估FXR0906在成人参与者中的免疫原性;评估FXR0906对成人参与者血脂相关探索性PD指标的影响(包括但不限于血清LDL-C、VLDL-C、总胆固醇、非HDL-C、HDL-C、ApoB、ApoB-48、ApoB-100、载脂蛋白A1(ApoA1)和残余胆固醇等)。
[Translation] Primary Objective: To evaluate the safety and tolerability of a single subcutaneous injection of FXR0906 in healthy Chinese adult participants with or without elevated triglycerides.
Secondary Objectives: To evaluate the plasma pharmacokinetic characteristics of FXR0906 and its metabolite AS3’N-1 in adult participants; to evaluate the effect of FXR0906 on serum APOC3 levels in adult participants; and to evaluate the effect of FXR0906 on serum TG levels in adult participants.
Exploratory Objectives: To evaluate the immunogenicity of FXR0906 in adult participants; and to evaluate the effect of FXR0906 on lipid-related exploratory PD markers in adult participants (including but not limited to serum LDL-C, VLDL-C, total cholesterol, non-HDL-C, HDL-C, ApoB, ApoB-48, ApoB-100, apolipoprotein A1 (ApoA1), and residual cholesterol, etc.).