Actively Recruiting

Phase 1
Age: 45Years - 60Years
FEMALE
Healthy Volunteers
NCT06995482

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

Led by Kashiv BioSciences, LLC · Updated on 2026-02-12

40

Participants Needed

2

Research Sites

41 weeks

Total Duration

On this page

Sponsors

K

Kashiv BioSciences, LLC

Lead Sponsor

E

Eric Solutions LLC

Collaborating Sponsor

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

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

Who Can Participate

Age: 45Years - 60Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Able to provide written informed consent and understand study procedures
  • Healthy postmenopausal females aged 45 to 60 years
  • Body mass index between 18 and 30 kg/m2
  • Postmenopause defined as no menstrual period for 12 months after age 50, or after age 45 with FSH > 40 mIU/mL
  • Healthy based on medical history, physical exam, vital signs, and ECG
  • Hemoglobin level at screening and Day -1 of at least 11 g/dl
  • Ability to communicate well and comply with study requirements
  • Adequate venous access for blood sampling
Not Eligible

You will not qualify if you...

  • History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, coagulation, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease
  • Evidence of organ dysfunction or abnormal lab values including liver or kidney function
  • QTc interval of 450 ms or more on ECG
  • Major surgery requiring general anesthesia within 3 months prior to screening
  • History or suspicion of alcohol or substance dependency
  • History of cancer within the last 5 years
  • Positive tests for HIV, hepatitis B, or hepatitis C
  • Vaccination within 2 weeks prior to dosing or during study
  • Blood donation or loss greater than 250 mL within 60 days prior to screening
  • Low platelet count, bleeding issues, or family history of bleeding disorders
  • History of hypersensitivity to heparin or the study drug or similar drugs
  • Estrogen-dependent conditions including benign breast conditions
  • History of osteoporosis or bone or steroid metabolism disease
  • Intolerance or fear of needles or blood draws
  • Positive pregnancy test or lactation
  • Use of investigational drugs within 28 days or 5 half-lives prior to study
  • Use of medications, herbal remedies, or megadose vitamins/minerals within 2 weeks prior to dosing
  • Consumption of grapefruit-containing foods or drinks within 7 days prior to dosing
  • Any condition that might interfere with study objectives as judged by investigator
  • Abnormal international normalized ratio (INR) at screening

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 2 locations

1

Floridian Clinical Research LLC

Miami Lakes, Florida, United States, 33016

Actively Recruiting

2

Synergen Bio Pvt. Ltd.

Pune, Maharashtra, India, 411003

Actively Recruiting

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Research Team

P

Pawan Singh

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

5

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