Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of KSHN001034 in Healthy Postmenopausal Female Volunteers

Launched by KASHIV BIOSCIENCES, LLC · May 21, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called KSHN001034 to see if it is safe and well-tolerated in healthy postmenopausal women. The trial will compare KSHN001034 to an existing treatment called Faslodex®, which is used for certain types of breast cancer. Participants will receive either KSHN001034 or Faslodex® through an injection, with doses being given in low, medium, or high amounts. The study will look closely at any side effects and how the body processes the medication.

To be eligible for this trial, women must be between 45 and 60 years old, in good health, and have a body mass index (BMI) between 18 and 30. They should also be postmenopausal, meaning they have not had a menstrual period for at least 12 months. Participants will need to communicate well and be able to provide blood samples. It’s important to note that certain health conditions or medications may exclude someone from participating. The trial is not yet recruiting, but if you or someone you know fits the eligibility criteria, this could be an opportunity to contribute to important research in breast cancer treatment.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Able to provide written Informed Consent and communicate with the investigator and comprehend study-related procedures.
• • 2. Healthy, postmenopausal females aged 45 to 60 years old (inclusive), as determined by medical history and physical examination.
• • 3. Body Mass Index at screening between 18 and 30 kg/m2, inclusive.
• • 4. 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/mL Note: Amenorrhea should not be due to lactation).
• • 5. 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).
• • 6. Hemoglobin at screening and Day (-1) ≥ 11 g/dl
• • 7. Ability to communicate well and to comply with the requirements of the entire study.
• • 8. Adequate venous access and can able to give required blood samples.
• Exclusion Criteria:
• • 1. 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.
• • 2. Evidence of organ dysfunction \[e.g. liver dysfunction; ≥ Upper Limit of Normal (ULN) for ALT, AST or ALP or renal dysfunction (\<90 mL/min of creatinine clearance by Cockroft-Gault formula\] or any clinically significant abnormalities in other clinical laboratory parameters at screening as determined by the investigator.
• • 3. QTc (Bazzett) interval ≥450 ms on ECG at screening.
• • 4. Any major surgery requiring general anesthesia within 3 months prior to screening.
• • 5. 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
• • 6. History or presence of malignancy in the last 5 years
• • 7. 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.
• • 8. Received or intending to receive a vaccination in the two weeks prior to dosing, or anytime during study participation.
• • 9. Donated blood within 60 days of screening or otherwise experienced blood loss of \>250 mL within the same period.
• • 10. Presence of low platelet count (i.e. lower than LLN), bleeding issues or family history of bleeding disorders.
• • 11. Participant has a history of hypersensitivity to heparin as checked at screening.
• • 12. History of hypersensitivity or idiosyncratic reaction to test drug or any drug chemically similar to the drug under investigation or any of the excipients.
• • 13. The participant has any estrogen- dependent conditions including benign breast conditions
• • 14. The participant has a history of osteoporosis or any disease affecting bone or steroid metabolism.
• • 15. Intolerance to/ fear of venipuncture, needles, or blood draws.
• • 16. Positive serum pregnancy test during screening or Lactating mothers
• • 17. Has received another new chemical entity/investigational drug within 28 days or 5 half-lives of investigational drug (whichever is longer) of the first administration of investigational product in this study.
• • 18. 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.
• • 19. The participant has consumed grapefruit-containing beverages and foods 7 days prior to dosing.
• • 20. Any condition that, in the opinion of the investigator, might interfere with study objectives.
• • 21. Subjects with abnormal international normalized ratio (INR) at screening