[Translation] Phase I clinical trial of safety, tolerability, pharmacokinetics and pharmacodynamics of single subcutaneous injection of long-acting human follicle stimulating hormone in healthy Chinese female subjects
主要目的: 评价SJ02药物在健康女性受试者中单次给药的安全性及耐受性; 次要目的: 评价SJ02药物在健康女性受试者中单次给药的药代动力学特征; 评价SJ02药物在健康女性受试者中单次给药的药效学特征; 评估SJ02药物在健康女性受试者中的免疫原性。
[Translation] Primary objective: To evaluate the safety and tolerability of a single dose of SJ02 in healthy female subjects; Secondary objective: To evaluate the pharmacokinetics of a single dose of SJ02 in healthy female subjects; To evaluate the pharmacodynamic profile of a single dose of SJ02 drug in healthy female subjects; to evaluate the immunogenicity of SJ02 drug in healthy female subjects.