[Translation] A single-center, randomized, double-blind, placebo-controlled, dose-escalating Phase Ia clinical trial to evaluate the safety, tolerability, and pharmacokinetics of a single dose of AA001 in healthy Chinese adult participants
主要目的:
评价健康成年参与者单次静脉滴注给予AA001单抗的安全性及耐受性。
次要目的:
1)评价健康成年参与者单次静脉滴注给予AA001单抗的药代动力学特征;
2)评价健康成年参与者单次静脉滴注给予AA001单抗的免疫原性。
[Translation] Primary objective:
To evaluate the safety and tolerability of a single intravenous infusion of AA001 monoclonal antibody in healthy adult participants.
Secondary objectives:
1) To evaluate the pharmacokinetic characteristics of a single intravenous infusion of AA001 monoclonal antibody in healthy adult participants;
2) To evaluate the immunogenicity of a single intravenous infusion of AA001 monoclonal antibody in healthy adult participants.