A Randomized, Double-blind, Placebo-controlled, Single and Multiple Dose Escalation Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of IMC-003 for Injection in Healthy Postmenopausal Women
Trial Parameters
Brief Summary
this study is a randomized, double-blind, placebo-controlled, single and multiple dose escalation Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of IMC-003 for injection in healthy postmenopausal women.
Eligibility Criteria
Inclusion Criteria: * (1) The age range for screening is 45 to 75 years (inclusive of the boundary values), and post-menopausal females; (2) Before screening, spontaneous amenorrhea has lasted for at least 12 months, or spontaneous amenorrhea for at least 6 months or amenorrhea caused by hysterectomy with serum FSH level \> 40 IU/L, or bilateral oophorectomy with or without hysterectomy for ≥ 6 weeks; (3) At the time of screening, the weight is ≥ 45 kg and the body mass index (BMI) is within the range of 18.0 to 30.0 kg/m2 (inclusive of the boundary values); (4) Physical examination, vital sign examination, electrocardiogram examination, laboratory tests, etc. are normal (platelet count is greater than the lower limit of the normal value) or judged by the investigator to be abnormal but without clinical significance; (5) Fully understand the trial content, the trial drug, the trial process, etc., can communicate well with the researcher, willing to abide by the trial regulations, and v