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

Exclusion Criteria21

• 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.
• 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.
• QTc (Bazzett) interval ≥450 ms on ECG at screening.
• Any major surgery requiring general anesthesia within 3 months prior to screening.
• 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
• History or presence of malignancy in the last 5 years
• 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.
• Received or intending to receive a vaccination in the two weeks prior to dosing, or anytime during study participation.
• Donated blood within 60 days of screening or otherwise experienced blood loss of \>250 mL within the same period.
• Presence of low platelet count (i.e. lower than LLN), bleeding issues or family history of bleeding disorders.
• Participant has a history of hypersensitivity to heparin as checked at screening.
• History of hypersensitivity or idiosyncratic reaction to test drug or any drug chemically similar to the drug under investigation or any of the excipients.
• The participant has any estrogen- dependent conditions including benign breast conditions
• The participant has a history of osteoporosis or any disease affecting bone or steroid metabolism.
• Intolerance to/ fear of venipuncture, needles, or blood draws.
• Positive serum pregnancy test during screening or Lactating mothers
• 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.
• 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.
• The participant has consumed grapefruit-containing beverages and foods 7 days prior to dosing.
• Any condition that, in the opinion of the investigator, might interfere with study objectives.
• Subjects with abnormal international normalized ratio (INR) at screening