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

"Test Product: KSHN001034, 5 mL vial containing 113 mg/mL of KSHN001034, equivalent to 100 mg/mL of fulvestrant. Manufactured for Kashiv Biosciences LLC, USA.~• 6 subjects will receive low dose of KSHN001034 IM on Days 1, 8, 15, and 22."

"Test Product: KSHN001034, 5 mL vial containing 113 mg/mL of KSHN001034, equivalent to 100 mg/mL of fulvestrant. Manufactured for Kashiv Biosciences LLC, USA.~• 6 subjects will receive medium dose of KSHN001034 IM on Days 1, 8, 15, and 22."

"Test Product: KSHN001034, 5 mL vial containing 113 mg/mL of KSHN001034, equivalent to 100 mg/mL of fulvestrant. Manufactured for Kashiv Biosciences LLC, USA.~• 6 subjects will receive high dose of KSHN001034 IM on Days 1, 8, 15, and 22."

"Test Product: KSHN001034, 5 mL vial containing 113 mg/mL of KSHN001034, equivalent to 100 mg/mL of fulvestrant. Manufactured for Kashiv Biosciences LLC, USA.~• 6 subjects will receive low dose of KSHN001034 SC on Days 1, 8, 15, and 22."

"Test Product: KSHN001034, 5 mL vial containing 113 mg/mL of KSHN001034, equivalent to 100 mg/mL of fulvestrant. Manufactured for Kashiv Biosciences LLC, USA.~• 6 subjects will receive medium dose of KSHN001034 SC on Days 1, 8, 15, and 22."

"Reference Product: Faslodex® (Fulvestrant), 5 mL pre-filled syringe containing 250 mg/5 mL of fulvestrant, administered as two 5 mL injections (total 500 mg) via intramuscular (IM) injection. Marketed by AstraZeneca.~• 2 subjects will receive 500 mg Fulvestrant IM on Days 1 and 15."