[Translation] A randomized, double-blind, placebo-controlled, single- and multiple-dose ascending phase I clinical trial evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of IMC-003 for injection in healthy postmenopausal women
主要目的:评估绝经后健康女性皮下注射IMC-003的安全性、耐受性。
次要目的:评估绝经后健康女性皮下注射IMC-003的药代动力学(PK)特征;评估IMC-003的免疫原性。
探索性目的:血液中卵泡刺激素(FSH)水平在给药前后的变化;探索绝经后健康女性皮下注射IMC-003对骨代谢生物标志物及骨密度(仅限于多次给药的受试者)的影响。
[Translation] Primary Objective: To evaluate the safety and tolerability of subcutaneous administration of IMC-003 in healthy postmenopausal women.
Secondary Objectives: To evaluate the pharmacokinetic (PK) profile of IMC-003 in healthy postmenopausal women; and to assess the immunogenicity of IMC-003.
Exploratory Objectives: To assess changes in follicle-stimulating hormone (FSH) levels in the blood before and after administration; and to investigate the effects of subcutaneous administration of IMC-003 on bone metabolism biomarkers and bone mineral density (limited to subjects who received multiple doses) in healthy postmenopausal women.