[Translation] A randomized, double-blind, parallel, single-dose subcutaneous Phase I clinical trial comparing the pharmacokinetic characteristics, safety and immunogenicity of QL2111 and Emgality® in healthy Chinese adult subjects
主要研究目的:研究单次皮下注射候选药QL2111与参照药Emgality®在健康受试者体内的药代动力学,评价皮下注射两种制剂的药代动力学相似性。
次要研究目的:研究单次皮下注射候选药QL2111 120mg和参照药Emgality®120mg在健康受试者中的安全性和免疫原性。
[Translation] Primary study objective: To study the pharmacokinetics of a single subcutaneous injection of the candidate drug QL2111 and the reference drug Emgality® in healthy subjects, and to evaluate the pharmacokinetic similarity of the two formulations for subcutaneous injection.
Secondary study objective: To study the safety and immunogenicity of a single subcutaneous injection of the candidate drug QL2111 120 mg and the reference drug Emgality® 120 mg in healthy subjects.