A Randomized, Double-blind, Placebo-controlled, Single and Multiple Dose Escalation Phase I Clini… (NCT07118085) | Clinical Trial Compass
RecruitingPhase 1
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
China56 participantsStarted 2025-08-18
Plain-language 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.
Who can participate
Age range45 Years – 75 Years
SexFEMALE
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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 voluntarily participate and sign the informed consent form.
Exclusion Criteria:
* The subjects must meet any of the following conditions to be eligible for this trial:
(1) (During the screening period/In the admission interview) They had or currently have clinically significant diseases or abnormalities as determined by the investigators, including but not limited to cardiovascular, respiratory, digestive tract, endocrine, hematological, liver, immune, metabolic, urinary, skin, central nerv…
What they're measuring
1
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
Timeframe: from enrollment to the end of treatment at 12 weeks
Trial details
NCT IDNCT07118085
SponsorImmuneOnco Biopharmaceuticals (Shanghai) Inc.