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

• Status: NOT_YET_RECRUITING
• Trial end date: 2026-04-01

Summary

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).

• Phase: PHASE1

Details

• Lead Sponsor: Kashiv BioSciences, LLC
• Collaborators: Clinexcel Research, Ahmedabad, India; Eric Solutions LLC
• Treatments: Fulvestrant