[Translation] A Phase I clinical study evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of LYN101 after a single dose in healthy subjects and multiple doses in postmenopausal women with low bone mass
主要目的:评估LYN101在健康受试者中单次给药和在低骨量绝经后女性受试者中多次给药的安全性和耐受性。 次要目的:评估LYN101单次给药、多次给药的药物代谢动力学特征、免疫原性以及生物标志物的影响。探索性目的:探索LYN101治疗后受试者骨密度(腰椎、全髋骨和股骨颈)的影响。
[Translation] Primary Objective: To evaluate the safety and tolerability of LYN101 after a single dose in healthy subjects and repeated doses in postmenopausal women with low bone mass. Secondary Objective: To evaluate the pharmacokinetic profile, immunogenicity, and biomarker effects of single and repeated doses of LYN101. Exploratory Objective: To investigate the effects of LYN101 treatment on bone mineral density (bone mineral density) at the lumbar spine, total hip, and femoral neck.