Comparing a new fulvestrant formulation (KSHN001034) to Faslodex in healthy postmenopausal women

A Phase 1, Open Label, Randomized, Multiple Ascending Dose (MAD) Study Evaluating the Safety, Tolerability and Pharmacokinetics of KSHN001034 in Healthy Postmenopausal Female Volunteers

We will test whether KSHN001034, a new formulation of fulvestrant given by intramuscular or subcutaneous injection, is safe and produces similar blood levels to Faslodex in healthy postmenopausal women.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 45 Years to 60 Years
• Sex: Female
• Sponsor: Kashiv BioSciences, LLC (Industry-sponsored)
• Locations: 2 sites (Miami Lakes, Florida and 1 other locations)
• Trial ID: NCT06995482 on ClinicalTrials.gov

What this trial studies

This is a phase 1, open-label, randomized multiple-ascending-dose comparison of KSHN001034 and US-licensed Faslodex (fulvestrant) in healthy postmenopausal women. Participants are randomized 3:1 to receive KSHN001034 (administered IM or SC at low, medium, or high dose across five sequential cohorts) or Faslodex 500 mg IM, with dose escalation governed by a DSMB after review of cumulative safety and PK data. PK blood sampling is performed from Day 1 through Day 36 to estimate parameters such as Cmax and AUC, while safety is monitored via adverse event reporting and CTCAE v5.0 grading. The primary outcome is safety and tolerability, with secondary endpoints comparing pharmacokinetic profiles between the test product and the reference product.

Who should consider this trial

Good fit: Ideal candidates are healthy postmenopausal women aged 45–60 years with BMI 18–30 kg/m2, adequate venous access, no significant medical conditions, and the ability to give informed consent and follow study procedures.

Not a fit: Women with active breast cancer, premenopausal status, significant comorbidities, abnormal screening labs, or those outside the specified age/BMI ranges are unlikely to receive benefit from participation.

Why it matters

Potential benefit: If successful, KSHN001034 could provide a fulvestrant option with similar exposure that may allow subcutaneous administration or improved tolerability and convenience compared with current intramuscular Faslodex.

How similar studies have performed: Fulvestrant (Faslodex) is an established drug and prior efforts to develop alternative or subcutaneous formulations have shown promise, but KSHN001034 is a novel formulation that still requires human PK and safety data.

Eligibility criteria

Inclusion Criteria:

1. Able to provide written Informed Consent and communicate with the investigator and comprehend study-related procedures.
2. Healthy, postmenopausal females aged 45 to 60 years old (inclusive), as determined by medical history and physical examination.
3. Body Mass Index at screening between 18 and 30 kg/m2, inclusive.
4. 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).
5. Participant must be healthy on the basis of their medical history, a physical examination, vital signs, and 12-lead Electrocardiogram (ECG) performed during screening and as determined by the Principal Investigator (PI).
6. Hemoglobin at screening and Day (-1) ≥ 11 g/dl
7. Ability to communicate well and to comply with the requirements of the entire study.
8. Adequate venous access and can able to give required blood samples.

Exclusion Criteria:

1. 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.
2. 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.
3. QTc (Bazzett) interval ≥450 ms on ECG at screening.
4. Any major surgery requiring general anesthesia within 3 months prior to screening.
5. Known or suspected history of alcohol dependency or addictive substance use, as judged by the investigator Note: Participants will be required to abstain from recreational use of soft addictive substances (such as marijuana) within 2 weeks or hard addictive substances (such as cocaine, phencyclidine, crack, opioid derivatives including heroin, and amphetamine derivatives) within 2 months prior to screening
6. History or presence of malignancy in the last 5 years
7. Positive testing for human immunodeficiency virus (HIV I or II), hepatitis B (hepatitis B surface antigen \[HBsAg\]), or hepatitis C (Anti-HCV antibody) at screening.
8. Received or intending to receive a vaccination in the two weeks prior to dosing, or anytime during study participation.
9. Donated blood within 60 days of screening or otherwise experienced blood loss of \>250 mL within the same period.
10. Presence of low platelet count (i.e. lower than LLN), bleeding issues or family history of bleeding disorders.
11. Participant has a history of hypersensitivity to heparin as checked at screening.
12. History of hypersensitivity or idiosyncratic reaction to test drug or any drug chemically similar to the drug under investigation or any of the excipients.
13. The participant has any estrogen- dependent conditions including benign breast conditions
14. The participant has a history of osteoporosis or any disease affecting bone or steroid metabolism.
15. Intolerance to/ fear of venipuncture, needles, or blood draws.
16. Positive serum pregnancy test during screening or Lactating mothers
17. Has received another new chemical entity/investigational drug within 28 days or 5 half-lives of investigational drug (whichever is longer) of the first administration of investigational product in this study.
18. Use of any prescribed or non-prescribed medication, herbal remedies, megadose vitamins (intake of 20 to 600 times the recommended daily dose) and minerals during the 2 weeks prior to the first administration of investigational product.
19. The participant has consumed grapefruit-containing beverages and foods 7 days prior to dosing.
20. Any condition that, in the opinion of the investigator, might interfere with study objectives.
21. Subjects with abnormal international normalized ratio (INR) at screening

Where this trial is running

Miami Lakes, Florida and 1 other locations

• Floridian Clinical Research LLC — Miami Lakes, Florida, United States (Recruiting)
• Synergen Bio Pvt. Ltd. — Pune, Maharashtra, India (Recruiting)

Study contacts

• Study coordinator: Pawan Singh

Conditions Healthy Postmenopausal Women