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.
(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 voluntarily participate and sign the informed consent form.
None
Parallel
experimental Arm IMC-003
DrugPart 1: Single Dose Dose Escalation (SAD): single administration, with the test drug or placebo administered respectively. Part 2: Multiple Dose Dose Escalation (MAD): Administer for 5 consecutive times (unless the subject cannot tolerate, withdraw prematurely, or is lost to follow-up, etc.), with the test drug or placebo administered respectively.
The placebo Arm: The placebo of IMC-003
DrugPart 1(SAD) subject will receive IMC-003 once ; Part 2 (MAD) subject will receive the placebo of IMC-003 for 5 times, with an interval of 21 days between each administration.
The number and incidence rate of adverse events (AE), serious adverse events (SAE), severity, as well as their correlation with the investigational drug; various laboratory tests, vital signs, physical examinations, 12-lead electrocardiogram, etc., showi
Click on the lead sponsor to view all of their trials.
