[Translation] A randomized, double-blind, placebo-controlled Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single-dose escalation of FY101 injection in Chinese participants
主要目的
(1)评价FY101注射液单次给药在中国参与者中的安全性和耐受性。
次要目的
(1)评价FY101注射液单次给药在中国参与者中的药代动力学特征;
(2)评价FY101注射液单次给药在中国参与者中的药效动力学特征;
(3)评价FY101注射液单次给药在中国参与者中的免疫原性。
[Translation] Primary objectives
(1) To evaluate the safety and tolerability of a single dose of FY101 injection in Chinese participants.
Secondary objectives
(1) To evaluate the pharmacokinetic characteristics of a single dose of FY101 injection in Chinese participants;
(2) To evaluate the pharmacodynamic characteristics of a single dose of FY101 injection in Chinese participants;
(3) To evaluate the immunogenicity of a single dose of FY101 injection in Chinese participants.