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.
Participants will:
Receive 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.
Dosing will be administered in a sequential cohort-wise manner across five cohorts, with DSMB oversight for safety monitoring and dose escalation.
Primary Endpoint:
Safety and tolerability will be assessed based on the occurrence, severity, and relationship of adverse events (AEs), including serious adverse events (SAEs).
Secondary Endpoint:
Pharmacokinetic (PK) parameters will be evaluated, including Cmax (maximum concentration), Tmax (time to maximum concentration), AUC (area under the curve), and T1/2 (half-life).
Able to provide written Informed Consent and communicate with the investigator and comprehend study-related procedures.
Healthy, postmenopausal females aged 45 to 60 years old (inclusive), as determined by medical history and physical examination.
Body Mass Index at screening between 18 and 30 kg/m2, inclusive.
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).
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.
Parallel
KSHN001034
DrugTest 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.
KSHN001034
DrugTest 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.
KSHN001034
DrugTest 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.
KSHN001034
DrugTest 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.
KSHN001034
DrugTest 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.
Fulvestrant
DrugReference 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.
Number of participants with treatment-related Adverse events as assessed by CTCAE v5.0
Adverse events reported after dosing will be evaluated
Pharmacokinetic parameter
Evaluate the Peak Plasma Concentration (Cmax)
Pharmacokinetic parameter
Evaluate the Area under the plasma concentration versus time curve (AUC)
Pharmacokinetic parameter
Evaluate the Time to maximum concentration (Tmax)
Pharmacokinetic parameter
Evaluate the half life (T1/2)
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Kashiv BioSciences, LLC
Lead sponsor
Eric Solutions LLC
Collaborator
Clinexcel Research, Ahmedabad, India
Collaborator
