[Translation] A randomized, double-blind, placebo-controlled phase I clinical trial in healthy participants to evaluate the safety, tolerability, and pharmacokinetics of different single and multiple doses of FB7013 injection.
主要目的:评价FB7013注射液在健康参与者中单剂量递增(SAD)和多剂量递增(MAD)的临床安全性、耐受性。
次要目的:
1. 获得FB7013注射液在健康参与者中的临床药代动力学特性。
探索性目的:
1. 评价FB7013注射液在健康参与者中对血浆MASP-2蛋白水平的影响。
2. 评价FB7013注射液对血清补体成分和活性的影响。
3. 评价FB7013注射液潜在的免疫原性。
[Translation] Primary Objective: To evaluate the clinical safety and tolerability of FB7013 injection in healthy participants using single-dose escalation (SAD) and multiple-dose escalation (MAD) regimens.
Secondary Objectives:
1. To obtain the clinical pharmacokinetic characteristics of FB7013 injection in healthy participants.
Exploratory Objectives:
1. To evaluate the effect of FB7013 injection on plasma MASP-2 protein levels in healthy participants.
2. To evaluate the effect of FB7013 injection on serum complement components and activity.
3. To evaluate the potential immunogenicity of FB7013 injection.