Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of KSHN001034 in Healthy Postmenopausal Female Volunteers
NCT06995482
This study is recruiting at 1 US site in 1 state, according to its ClinicalTrials.gov record last updated .
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.
Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov
Conditions studied
- Healthy Postmenopausal Women
Eligibility basics and study details
- Study type
- Interventional
- Phase
- Phase 1
- Ages
- 45 to 60 years
- Sex
- Female
- Healthy volunteers
- Accepted
- Sponsor
- Kashiv BioSciences, LLC
- Last updated on ClinicalTrials.gov
- February 12, 2026
These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.
US recruiting sites
Florida · 1
- Floridian Clinical Research LLC · Miami Lakes, FL
Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.