[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"healthy-postmenopausal-women\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:healthy-postmenopausal-women":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":5},"100592596","phase-1-multiple-ascending-dose-study-to-evaluate-the-safety-tolerability-and-pharmacokinetics-of-kshn001034-in-healthy-postmenopausal-female-volunteers-100592596",false,"NCT06995482","Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of KSHN001034 in Healthy Postmenopausal Female Volunteers","A Phase 1, Open Label, Randomized, Multiple Ascending Dose (MAD) Study Evaluating the Safety, Tolerability and Pharmacokinetics of KSHN001034 in Healthy Postmenopausal Female Volunteers","Inclusion Criteria:\n\n1. Able to provide written Informed Consent and communicate with the investigator and comprehend study-related procedures.\n2. Healthy, postmenopausal females aged 45 to 60 years old (inclusive), as determined by medical history and physical examination.\n3. Body Mass Index at screening between 18 and 30 kg\u002Fm2, inclusive.\n4. Post-menopausal females (Menopause is defined as the female is either 12 months off menstrual period after the age of 50 years, or 12 months off menstrual period after the age of 45 years and FSH \\> 40 mIU\u002FmL Note: Amenorrhea should not be due to lactation).\n5. Participant must be healthy on the basis of their medical history, a physical examination, vital signs, and 12-lead Electrocardiogram (ECG) performed during screening and as determined by the Principal Investigator (PI).\n6. Hemoglobin at screening and Day (-1) ≥ 11 g\u002Fdl\n7. Ability to communicate well and to comply with the requirements of the entire study.\n8. Adequate venous access and can able to give required blood samples.\n\nExclusion Criteria:\n\n1. History or presence of cardiovascular, pulmonary, hepatic, renal, hematologic, coagulation, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease or any other clinical significant abnormalities during screening investigations which, in the opinion of the PI, may either put the participant at risk because of participation in the study, or influence the results or the participant's ability to participate in the study.\n2. Evidence of organ dysfunction \\[e.g. liver dysfunction; ≥ Upper Limit of Normal (ULN) for ALT, AST or ALP or renal dysfunction (\\\u003C90 mL\u002Fmin of creatinine clearance by Cockroft-Gault formula\\] or any clinically significant abnormalities in other clinical laboratory parameters at screening as determined by the investigator.\n3. QTc (Bazzett) interval ≥450 ms on ECG at screening.\n4. Any major surgery requiring general anesthesia within 3 months prior to screening.\n5. Known or suspected history of alcohol dependency or addictive substance use, as judged by the investigator Note: Participants will be required to abstain from recreational use of soft addictive substances (such as marijuana) within 2 weeks or hard addictive substances (such as cocaine, phencyclidine, crack, opioid derivatives including heroin, and amphetamine derivatives) within 2 months prior to screening\n6. History or presence of malignancy in the last 5 years\n7. Positive testing for human immunodeficiency virus (HIV I or II), hepatitis B (hepatitis B surface antigen \\[HBsAg\\]), or hepatitis C (Anti-HCV antibody) at screening.\n8. Received or intending to receive a vaccination in the two weeks prior to dosing, or anytime during study participation.\n9. Donated blood within 60 days of screening or otherwise experienced blood loss of \\>250 mL within the same period.\n10. Presence of low platelet count (i.e. lower than LLN), bleeding issues or family history of bleeding disorders.\n11. Participant has a history of hypersensitivity to heparin as checked at screening.\n12. History of hypersensitivity or idiosyncratic reaction to test drug or any drug chemically similar to the drug under investigation or any of the excipients.\n13. The participant has any estrogen- dependent conditions including benign breast conditions\n14. The participant has a history of osteoporosis or any disease affecting bone or steroid metabolism.\n15. Intolerance to\u002F fear of venipuncture, needles, or blood draws.\n16. Positive serum pregnancy test during screening or Lactating mothers\n17. Has received another new chemical entity\u002Finvestigational drug within 28 days or 5 half-lives of investigational drug (whichever is longer) of the first administration of investigational product in this study.\n18. Use of any prescribed or non-prescribed medication, herbal remedies, megadose vitamins (intake of 20 to 600 times the recommended daily dose) and minerals during the 2 weeks prior to the first administration of investigational product.\n19. The participant has consumed grapefruit-containing beverages and foods 7 days prior to dosing.\n20. Any condition that, in the opinion of the investigator, might interfere with study objectives.\n21. Subjects with abnormal international normalized ratio (INR) at screening",true,"FEMALE","45 Years","60 Years",{"count":21,"type":22},40,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","The goal of this clinical trial is to evaluate if KSHN001034 demonstrates safety, tolerability, and a comparable pharmacokinetic (PK) profile to the reference product, Faslodex® (fulvestrant), which is used for the treatment of hormone receptor-positive breast cancer.\n\nParticipants will:\n\nReceive either the test product (KSHN001034) or the reference product (Faslodex®) administered intramuscularly (IM) or subcutaneously (SC) at doses of low, medium, or high , with doses conducted in 5 cohorts and these participants will be healthy postmenopausal female volunteers.\n\nDosing will be administered in a sequential cohort-wise manner across five cohorts, with DSMB oversight for safety monitoring and dose escalation.\n\nPrimary Endpoint:\n\nSafety and tolerability will be assessed based on the occurrence, severity, and relationship of adverse events (AEs), including serious adverse events (SAEs).\n\nSecondary Endpoint:\n\nPharmacokinetic (PK) parameters will be evaluated, including Cmax (maximum concentration), Tmax (time to maximum concentration), AUC (area under the curve), and T1\u002F2 (half-life).",[28],"Healthy Postmenopausal Women","RECRUITING","2026-02-10",{"date":32,"type":33},"2026-02-12","ACTUAL",{"date":35,"type":33},"2025-08-18",{"date":37,"type":22},"2026-06",{"name":39,"class":40},"Kashiv BioSciences, LLC","INDUSTRY",{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":47,"enrollmentInfo":48,"targetDuration":4,"studyType":23,"phases":50,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":53,"lastUpdatePostDateStruct":54,"startDateStruct":56,"completionDateStruct":57,"leadSponsor":59,"locationsCount":62},"100602021","phase-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-100602021","NCT07118085","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","Inclusion Criteria:\n\n* (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\u002FL, 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\u002Fm2 (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.\n\nExclusion Criteria:\n\n* The subjects must meet any of the following conditions to be eligible for this trial:\n\n  (1) (During the screening period\u002FIn 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 nervous system, and chronic kidney diseases, or diseases that the investigators consider to have safety issues or affect the PK evaluation; (2) (During the screening period\u002FIn the admission interview) They have active bleeding (such as peptic ulcer, intracranial hemorrhage, skin ecchymosis, nosebleed, gum bleeding) at present; or within the previous 6 months, they have any disease history that may increase the risk of bleeding (such as tumor bleeding, spontaneous hematoma, eye bleeding, hemoptysis, gastrointestinal bleeding or ulcer, hematuria, frequent nosebleeds\u002Fgum bleeding, frequent subcutaneous or skin ecchymosis, etc.); (3) (During the screening period\u002FIn the admission interview) They have a history of malignant tumors in the past or currently; (4) (During the screening period\u002FIn the admission interview) They have a history of thrombosis, cerebral infarction, or myocardial infarction; (5) (During the screening period\u002FIn the admission interview) They cannot tolerate venipuncture blood collection or have a history of fainting or hemoversion; (6) (During the screening period\u002FIn the admission interview) They have a history of tuberculosis, or they have a severe local or systemic infection within 3 months before screening; (7) (During the screening period\u002FIn the admission interview) They have a severe allergic history (such as angioedema, anaphylactic shock), allergic constitution (such as being allergic to pollen, two or more drugs\u002Ffood), or are known to have previously been allergic to large molecule protein preparations\u002Fmonoclonal antibodies, known to be allergic to the test drug or its excipients or similar drugs; (8) (During the screening period\u002FIn the admission interview) They have used any prescription drugs or herbal medicines within 4 weeks before administration, and used over-the-counter drugs or dietary supplements (including vitamins, calcium supplements, etc.) within 2 weeks; (9) (During the screening period\u002FIn the admission interview) They have used drugs that may affect bone metabolism within 6 months before administration, and are expected to use drugs that may affect bone metabolism during this trial. These drugs include but are not limited to the following: estrogen-containing contraceptives, bisphosphonates, fluoride, hormone replacement therapy (such as terbutalone, estrogen, estrogen-like compounds, such as raloxifene), calcitonin, strontium, parathyroid hormone or its derivatives, vitamin D supplements (\\>1000 IU\u002Fday), calcium supplements, glucocorticoids (except those who used inhaled or other local corticosteroid drugs within 2 weeks before screening), anabolic steroid drugs (such as megestrolone, phenylpropionate nandrolone, hydroxyethyl testosterone, stanazolol, kalicornol, danazol, etc.), calcitriol, etc.; and any drugs that affect platelet function or cause changes in the body's coagulation function; (10) (During the screening period\u002FIn the admission interview) They have used teriparatide; (11) (During the screening period\u002FIn the admission interview) They have used any drugs that affect platelet count, function, or cause changes in the body's coagulation function within 4 weeks before administration; (12) (During the screening period\u002FIn the admission interview) They have donated blood or had a blood loss of ≥ 400 mL within 3 months before administration; (13) (During the screening period\u002FIn the admission interview) They have undergone major surgery within 3 months before screening or are expected to have major surgery during this trial (including the screening period); (14) (During the screening period\u002FIn the admission interview) They are heavy smokers or have a daily smoking amount of ≥ 5 cigarettes within 3 months before administration, or they cannot stop using any tobacco products during the trial; (15) (Screening period \u002F Admission consultation) Alcoholics or those who consumed more than 14 standard units of alcohol per week within 6 months prior to the first administration (1 standard unit contains 17.5 ml or 14 grams of pure alcohol, the alcohol content of different types of beverages is indicated by volume ratio, and the daily alcohol intake is equivalent to 70 ml of 50° liquor or 700 ml of 5° beer), or those who were unwilling to stop drinking alcohol or consuming any alcoholic products during the trial; those with a positive alcohol breath test result; (16) (Screening period \u002F Admission consultation) Those who consumed excessive tea, coffee, and\u002For caffeinated beverages every day within 3 months prior to screening (more than 8 cups, 1 cup = 250 mL); (17) (Screening period \u002F Admission consultation) Those with a history of drug abuse, or those with positive results from multiple drug screening tests for urine combined screening; (18) (Screening period \u002F Admission consultation) Those who have previously used drugs targeting the same target, including participants in clinical studies of drugs targeting the same target; (19) (Screening period \u002F Admission consultation) Those who participated in any clinical trials of drugs or medical devices within 3 months prior to administration and used the study drugs, vaccines, or devices; (20) Those with positive results for hepatitis B surface antigen, hepatitis C virus antibody, human immunodeficiency virus antibody, or Treponema pallidum specific antibody; (21) (Screening period \u002F Admission consultation) Those cannot guarantee that they will refrain from consuming drugs, foods, or beverages that can induce or inhibit liver metabolic enzymes from 1 week before the trial and throughout the trial period; (22) Other reasons as determined by the investigator that make participation in this trial inappropriate.","75 Years",{"count":49,"type":22},56,[25],"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.",[28],"2025-12-07",{"date":55,"type":33},"2025-12-15",{"date":35,"type":33},{"date":58,"type":22},"2027-08-20",{"name":60,"class":61},"ImmuneOnco Biopharmaceuticals (Shanghai) Inc.","OTHER",1]