SAD Study to Evaluate Safety, Tolerability, and Pharmacokinetic Profile of AMN1126 in Healthy Post-Menopausal Females

Exclusion Criteria

• •1. The participant is surgically induced postmenopausal female.
• •2. Pregnant or lactating female participant.
• •3. Any history of clinically significant cardiac, renal, neurologic, metabolic, pulmonary, gastrointestinal, chronic hepatic disease or any other disease which in the judgment of the Investigator would interfere with the study or confound the study results.
• •4. History of allergy or major allergic reaction considered to be clinically significant by the Investigator.
• •5. Receiving or has received any investigational drug within the 30 days before receiving KSHN001126.
• •6. History or presence of low platelet count, bleeding issues or family history of bleeding disorders.
• •7. Participant has a history of hypersensitivity to heparin as checked at screening.
• •8. The participant has known allergy to the drug under investigation, or to any ingredient in the preparation
• •9. The participant has an evidence of antagonistic personality, poor motivation, emotional or intellectual problems likely to limit the validity of the consent to participation in the study or limit the ability to comply with the protocol requirements.
• •10. Donated blood within 60 days of screening or otherwise experienced blood loss of \>250 mL within the same period.
• •11. Intending to begin new concomitant drug therapy or over-the-counter medication anytime from screening to the time of administration of study drug.
• •12. Received or intending to receive a vaccination in the two weeks prior to dosing, or anytime during study participation.
• •13. Received treatment with a drug that has not received regulatory approval for an indication during the 60 days preceding study enrollment.
• •14. History of drug and/or alcohol dependence within past 12 months, and/or positive results on drug of abuse or alcohol tests.
• •15. The participant is a smoker (smoker is defined as reporting tobacco use in the previous 3 months and/or has urine cotinine level equal or more than 500 ng/ml)
• •16. Has taken any regular, prescribed, or over-the-counter medication with the exception of acetaminophen (maximum 2 g/day) or multi- vitamins in the 2 weeks prior to dosing (other medication may only be taken with the specific approval of the Investigator in consultation with the Medical Monitor).
• •17. The participant with history of consuming alcohol or caffeine or related xanthine containing foods or beverages such as caffeine in tea, coffee, chocolates, cola and pepsi for 48 hours prior to dosing.
• •18. The participant has consumed grapefruit-containing beverages and foods 7 days prior to dosing.
• •19. Malignancy within the last 5 years, with the exception of successfully treated basal cell carcinoma and carcinoma in situ uteri.
• •20. The participant has prior history of hormonal replacement therapy.
• •21. The participant has any estrogen- dependent conditions including breast cancer.
• •22. Any condition that, in the opinion of the investigator, might interfere with study objectives.
• •23. The participant has a history of osteoporosis or any disease affecting bone or steroid metabolism.
• •24. Intolerance to/ fear of venipuncture, needles, or blood draws